Skip to main content
NCBI home page
NIHPA Author Manuscripts logoLink to NIHPA Author Manuscripts
. Author manuscript; available in PMC: 2026 Jan 30.
Published before final editing as: J Subst Use Addict Treat. 2025 Nov 27:209849. doi: 10.1016/j.josat.2025.209849

Gender-specific addiction research needed now more than ever: Reflections from 25 years of the NIDA Clinical Trials Network Gender Special Interest Group

Aimee N C Campbell a, A Kathleen Burlew b, Constance Guille c, Mia A Haidamus d, Denise A Hien e, Therese Killeen c, Michelle R Lofwall f, Margaret M Paschen-Wolff a, Christi A Patten g, Dawn E Sugarman d,h, T John Winhusen b, Ludmila N Bakhireva i, Amy M Loree j, Shayna Mazel k, Shelly F Greenfield d,h
PMCID: PMC12853563  NIHMSID: NIHMS2131662  PMID: 41314548

1. INTRODUCTION

1.1. Women & Substance Use Disorder Research Landscape

Research on substance use disorders (SUDs) has historically disproportionately focused on male populations resulting in a limited understanding regarding the etiology, progression, and treatment outcomes of SUDs in women. The establishment of the Office of Research on Women’s Health (ORWH, 2021) in 1990 marked a pivotal step toward addressing gender disparities in addiction research. However, the inclusion of women in clinical studies remained limited until the U.S. government’s 1993 mandate advocating for the inclusion of women of childbearing potential (FDA, 1993). This initiative was further reinforced by the National Institutes of Health (NIH) mandate that women and minority populations be included in federally funded clinical trials (FDA, 1994). NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research updated in 2001 stated that investigators conducting Phase III clinical trials must review evidence “to show whether or not clinically important sex/gender and race/ethnicity differences in the intervention effect are to be expected” and have a proposed plan for the appropriate analysis of these differences (NIH, 2022).

In the 1980s, men were five times more likely than women to meet criteria for alcohol use disorder (AUD) (Helzer et al., 1991); the ratio narrowed to 1.4:1 in 2023 (Substance Abuse and Mental Health Services Administration [SAMHSA], 2024). Between 2001 and 2013, heavy drinking among women increased by 58% versus a 16% increase in men and past-year prevalence of AUD in women increased by 84% versus 35% in men (Grant et al., 2017). Between 2013 and 2019, the gender gap narrowed across all SUDs, with significant variation by race, ethnicity, and marginalized identities (Center for Behavioral Health Statistics and Quality, 2021; Mereish et al., 2014; Mereish et al., 2023; Keuroghlian et al., 2015; Hughto et al., 2021). Given the rapidly closing disparity in substance use between men and women (Keyes et al., 2011; Seedat et al., 2010; White et al., 2020), more robust research on the intersection of sex, gender, and SUDs is critically needed.

Multiple studies demonstrate significant sex- and gender-related differences in SUD trajectories. Women tend to advance more rapidly from initial substance use to SUD than men, a phenomenon referred to as “telescoping” (Lewis et al., 2014; Randall et al., 1999; Diehl et al., 2007; Hernandez et al., 2004; Towers et al., 2023). Women with SUDs also exhibit higher rates of and more severe co-occurring psychiatric disorders (e.g., depression, anxiety, eating disorders, posttraumatic stress disorder [PTSD]) (Polak et al., 2023; Kliewer et al., 2022). Furthermore, upon treatment entry, women exhibit heightened vulnerability to adverse medical and social consequences of substance use (Office of Public Health and Science, 2012); Gentilello et al., 2000; Henskens et al., 2005) and can exhibit more severe symptoms than men, raising notable clinical and public health concerns.

Findings on treatment efficacy by gender are mixed. Several large randomized clinical trials (RCTs) of SUD treatment have not identified gender differences in primary treatment outcomes (e.g., days of use, abstinence) (Greenfield et al., 2010; McHugh et al., 2013) as men and women may appear to respond similarly to behavioral and/or pharmacotherapy interventions (Hien et al., 2010; McHugh et al., 2018). However, the interaction of gender with other factors, such as socioeconomic status, psychiatric comorbidities, and trauma histories, can differentially impact treatment efficacy and recovery trajectories between men and women (McHugh et al., 2018; Sugarman et al., 2017).

The recognition of gender differences in SUDs has led to the development of gender-specific treatments for women (i.e., designed to address unique biopsychosocial factors influencing women’s substance use and recovery; Johnstone et al., 2023), including group therapy for women with SUD (Greenfield et al., 2014), pregnant and postpartum women (Kropp et al., 2023; see also Habersham et al., 2025), women with co-occurring trauma (Hien et al., 2019), and women in the criminal legal system (Messina et al., 2016; Messina et al., 2021). Gender-specific treatment programs have been associated with improved treatment outcomes compared to mixed-gender programs, primarily driven by enhanced retention and recovery rates among women (Johnstone et al., 2023; McHugh et al., 2018; Niv & Hser, 2007; Greenfield et al., 2014; Valeri et al., 2018). Despite unique treatment needs and the availability of effective interventions, many women with SUDs remain untreated due to systemic barriers, stigma, and limited access (Barbosa-Leiker et al., 2021; Greenfield et al., 2007; Levine et al., 2023). Moreover, women have lower treatment retention than men (McCrady et al., 2020). These gaps in knowledge underscore the urgent need for increased investigation into the relationship between gender, sex, and SUDs (Meyer et al., 2019).

1.2. Gender Special Interest Group: Role & Impact within NIDA’s Clinical Trials Network

The National Institute on Drug Abuse National Drug Abuse Treatment Clinical Trials Network (CTN) is a national SUD research network comprised of 16 academic “nodes” and their community partners (e.g., healthcare organizations; SUD treatment, mental health, and harm reduction programs) located throughout the U.S. The CTN-affiliated Gender Special Interest Group (GSIG) was a resource providing consultation to CTN investigators and other research team members to incorporate gender-related considerations into the development, planning, design, and execution of new studies. This resource included consultation on recruitment, retention, assessment, treatment, and outcomes for women with SUD. Similarly, the GSIG advised on the development of data analytic plans to accommodate a specific sample of women and gender diverse participants, analyses of sex and gender differences, and/or analyses of differences among subgroups of women participants, including race/ethnicity, socioeconomic, and co-occurring mental health disorders/symptoms.

Convened in 2000 (and formally supported through February 2025), the GSIG was one of the longest running special interest groups in the CTN. This group of investigators continues to meet monthly and is comprised of approximately 40 network members. GSIG members identify critical areas of investigation concerning SUD treatment for women (including adolescent girls and transgender women), and other gender diverse people (e.g., non-binary individuals) historically underrepresented in and excluded from research. The GSIG has developed concepts, conducted secondary data analyses (Paschen-Wolff et al., 2023; Campbell et al., 2018; Barbosa-Leiker et al., 2020) and critical reviews pertaining to sex and gender differences and gender-related issues in SUD treatment (Greenfield et al., 2007; Brooks et al., 2013; Barbosa-Leiker et al., 2021), including a recent JAMA Psychiatry commentary on the research impact of the 2023 U.S. Supreme Court decision overturning Roe v. Wade (Campbell & Greenfield, 2024).

The following sections illustrate these efforts through examples of (1) women-specific CTN trials (see Table 1); and (2) secondary analyses of data from CTN trials to ascertain sex differences in outcomes and other measures. This article concludes with recommendations for sex and gender-relevant research.

TABLE 1:

Summary of Key Trials with Women in the NIDA Clinical Trials Network (CTN)

Trial number Title Study population Intervention Key findings
CTN-0013 Motivational Enhancement Therapy (MET) for Pregnant Women Women with substance use disorders (SUD) who are pregnant Randomized controlled trial (RCT) of MET vs. standard of care No difference between MET and standard care; MET might be more beneficial in minoritized racial/ethnic groups.
CTN-0015 Women and Trauma Study (WTS) Women with SUD and posttraumatic stress disorder (PTSD) in community treatment settings RCT of integrated PTSD and SUD cognitive behavioral intervention vs. health education control Significant improvements in PTSD symptoms and substance use outcomes in both arms. Evidence for safety of trauma groups in SUD care. Addressing trauma is essential for achieving recovery in this population.
CTN-0019 Reducing HIV Risk Behaviors Among Women in Drug Treatment Women with SUD in community treatment settings RCT of 5-session safer sex skills building intervention vs. 1-session HIV education Gender-specific, skills building was effective and sustainable in reducing sexual risk behavior
CTN-0080 Medication Treatment for opioid use disorder (OUD) in Expectant Mothers (MOMs) Adults, 18–41 years with singleton pregnancies RCT of weekly long-acting injectable buprenorphine vs. sublingual buprenorphine or buprenorphine/naloxone Pending results: maternal illicit opioid use during pregnancy and 1-year postpartum, neonatal opioid withdrawal severity
CTN-0123 Wiidookaage’Win: Developing a Facebook program for Supporting Opioid Recovery Among American Indian (AI) Women AI or Alaska Native women in an urban native community, ≥18 years, prescribed medications for OUD with ≥1 month of opioid abstinence Private, 3-month, moderated, culturally aligned Facebook group intervention as an adjunct to medications for OUD (uncontrolled pilot) Intervention receptivity high. Key themes included the importance of culture, drawing upon strengths, and confidentiality and trust. Treatment satisfaction was very high.
Open in a new tab

2. GENDER-SPECIFIC TRIALS IN THE CTN

2.1. CTN-0013 Motivational Enhancement Therapy (MET) to Improve Treatment Utilization and Outcome in Pregnant Women with SUDS

This study was developed with the goal of comparing three individual motivational enhancement therapy (MET) sessions to standard treatment among pregnant women. MET sessions focused on developing rapport, exploring perceived pros and cons of using substances, reviewing client feedback about substance use consequences and the status of pregnancy, and developing a change plan or strengthening the commitment to change. Participants attended 62% of scheduled treatment on average and reported decreased substance use during the first month of treatment; there were no differences between MET and standard care. Results suggested efficacy of MET varied by clinical site and that MET might be more beneficial, versus standard care, for decreasing substance use in participants from minoritized racial/ethnic groups.

2.2. CTN-0015 Women and Trauma Study (WTS)

The Women and Trauma Study (WTS) represents a groundbreaking effort to address co-occurring trauma-related disorders and SUD among women. As the largest RCT on women with SUDs in community settings, WTS has significantly influenced both clinical practice and research methodologies, with implications for improving outcomes in this vulnerable population (Hien, Wells et al., 2009; Hien et al., 2010; Hien et al. 2015).

2.2.1. Study Scope and Implementation

Adult women (N=353) across six states and seven community treatment programs were enrolled. The protocol development team included an equal mix of clinical researchers and community providers; these same groups were involved in all subsequent publications (over 35 to date with 74 co-authors). This extensive collaboration reflected the study’s commitment to inclusivity and comprehensive data collection. WTS compared Seeking Safety (Najavits, 2002), a cognitive behavioral treatment of PTSD and SUD, with Women’s Health Education (Hien et al., 2009), a health education attention control.

2.2.2. Key Findings and Contributions

WTS demonstrated that integrating trauma-focused care improved PTSD symptoms and had downstream impact on substance use outcomes (Hien et al., 2004; Hien, Litt et al., 2009; Killeen et al., 2008). Further, the study provided evidence that integrated, dual-focus trauma groups could be safely implemented in substance use care (Killeen et al., 2008). The study provided solid evidence that treatment addressing trauma is essential for achieving recovery in this population and opened the door to future studies to apply trauma-processing models which are currently the gold standard of care for PTSD (Back et al., 2010; Brady et al., 1997; Hien et al., 2015; Norman et al., 2019).

The integration of PTSD and SUD treatment through skills-based trauma models like Seeking Safety marked a pivotal shift in how community programs approach co-occurring disorders (Hien, Wells et al., 2009; Hien et al., 2010; Hien et al. 2015; Hien et al., 2020). Notably, many of the participating programs had not previously assessed trauma, but through WTS, they became regional leaders in providing trauma-informed care with over 100 clinicians trained in the skills-based treatment models (Hien et al., 2020).

The study dataset was also used in several secondary analysis grants to advance research methods by employing data-driven techniques to identify subthreshold and full PTSD (Hien et al., 2015; Morgan-Lopez et al., 2020; Ruglass et al., 2014), utilizing Item Response Theory (IRT) and other statistical innovations to reduce measurement bias and enhance equity in diagnostic assessments (Hien, Cohen et al., 2009; Morgan-Lopez et al., 2020; Ruglass et al., 2015; Ruglass et al., 2020; Saavedra et al., 2021). Additionally, Project Harmony pooled raw data of individual patients from 39 international clinical trials to examine comparative effectiveness of eight different treatment types (behavioral and pharmacological) to treatment-as-usual, corrected for measurement non-equivalences and other data biases (Hien et al., 2024; Hien et al, 2023). These methodological innovations paved the way for defining clinically significant changes in recovery outcomes beyond traditional abstinence metrics contributing to more equitable and effective diagnostic practices.

2.2.3. Secondary Study Findings: Eating Disorders

WTS also implemented an ancillary study (CTN0015-A) to assess the prevalence of eating disorder (ED) symptoms, their relationship to SUD and PTSD symptoms, and their impact on treatment outcomes among a subset of women (n=122) from the larger trial, given that EDs are more prevalent in women than men (Luce et al., 1999; Mond et al., 2004; Udo et al., 2018) and among people with SUD (Bahij et al., 2019; Robinson et al., 2023). A common path between these two disorders is trauma; both substance use and eating behaviors may be used to self-treat symptoms (Brady et al., 1997). At baseline, women in this study reported concerns about weight, shape, and eating at a higher rate (38.7%) than women in the general US population. Women endorsing any past 28-day binge eating episodes at baseline (29%) had significantly less improvement in both PTSD symptom reduction and SUD abstinence (Cohen et al., 2010).

CTN GSIG researchers also utilized a large national dataset of private (N=345) and public (N=351) SUD treatment programs to evaluate ED assessment and treatment practices. Although half of programs reported screening for ED, less than 15% used standardized instruments and only 15%–17% reported attempting to treat individuals with low intensity ED (Gordon et al., 2008; Killeen et al., 2011). ED treatment is complex but critical to address alongside co-occurring SUD to promote sustained recovery (Brewerton et al., 2014).

2.3. CTN-0019 Reducing HIV Risk Behaviors Among Women in Drug Treatment

In the mid-2000s, a pair of studies tested HIV risk reduction interventions designed specifically for the unique needs of women and men. Women who use drugs, even if they are in drug treatment, are at especially high risk of HIV because they are often in primary sexual relationships with men who use drugs, some continue to use drugs despite being in treatment, and, under the influence of drugs are more likely to engage in condomless sex. SUD treatment had previously been shown to reduce activities related to drug use that increase the risk of HIV transmission (Sorensen & Copeland, 2000), but sexual risk behaviors had received less attention. CTN-0019, the women’s risk reduction protocol (Safer Sex Skills Building), evaluated a 5-session, group-delivered program for women in SUD treatment designed to build safer sex skills and reduce condomless sexual risk behavior (Tross et al., 2008). Compared to standard of care at the time (one session of HIV education), findings showed that Safer Sex Skills Building was effective and sustainable in reducing women’s risk behavior in community SUD treatment.

2.3.1. Adaptation of the Safer Sex Skills Building Intervention with Black Women

The CTN-0019 trial results led to a subsequent non-CTN study investigating whether culturally adapting the risk reduction intervention to address the unique risk factors facing Black women would increase effectiveness (Burlew et al., 2023). In collaboration with Black women with lived experience, systematic surface and deep-structural adaptation methods were used to refine and pilot the intervention (Falzarano & Zipp, 2013; Resnicow et al., 2000; Wingood & DiClemente, 2008;). Modifications altered the presentation without changing the curriculum (e.g., changing names in scenarios to be more culturally familiar) and supplemented the core components with curriculum to incorporate culture, social experiences, and values (e.g., examination of the role of community gender norms on sexual decision-making).

In the pilot work, Black women (N=48) were recruited from a substance use treatment clinic and participated in three 2.5-hour sessions of either the culturally adapted or standard intervention. At 6-week follow-up, more (48%) women in the culturally adapted version self-reported condom use with their casual partners versus (29%) in the standard version; the groups did not differ on self-reported condom use with primary partners. Cultural adaptation of efficacious HIV risk reduction interventions offers promise among Black women who use substances.

2.4. CTN-0080 Medication Treatment for Opioid Use Disorder (OUD) in Expectant Mothers (MOMS): A Pragmatic Randomized Trial Comparing Two Buprenorphine Formulations

CTN-0080 is a multi-site, two-arm, open-label, non-inferiority trial evaluating long-acting injectable (LAI) buprenorphine compared to sublingual (SL) buprenorphine (B) or buprenorphine/naloxone (B-Nx) during the peripartum period on an array of maternal, neonatal, and infant outcomes. Adults 18–41 years with singleton pregnancies were enrolled and randomized to weekly injectable CAM2038 (Brixadi®) or SL B/B-Nx whereby study medication was available throughout pregnancy and one-year postpartum. The primary study objective is to evaluate the effects of LAI-B versus SL B/B-Nx on maternal illicit opioid use during pregnancy and one year postpartum, measured by urine drug screen and neonatal opioid withdrawal severity measured by the number of days infants received opioid treatment in the hospital. Determining the economic value of LAI-B, compared to SL B/B-Nx, is another study objective.

2.4.1. Findings to Date

A total of 140 pregnant participants were randomized. Data collection is complete and analyses began in early 2025 on main study outcomes. Several CTN-0080-related papers have already contributed to the field. One paper focused on the organizational characteristics of the clinical sites treating pregnant persons with opioid use disorder (OUD) and the services offered (Kropp et al., 2023). Also, a baseline assessment of 155 pregnant participants screened for CTN-0080 evaluated trauma experiences and the association between persisting posttraumatic distress (PPD) events and health-related quality of life (HRQoL) (Winhusen et al., 2025). Over half (54.8%) had PPD events and, compared to participants without PPD events, reported greater pain interference; those experiencing childhood PPD events had significantly worse HRQoL. This analysis highlights the importance of trauma screening, trauma informed care, and access to mental health services. Lastly, a published case report described the use of LAI-B shared lessons learned from the clinical sites and practical tips on dose titration, management of injection site reactions, and fear of needles (Lofwall et al., 2023).

2.4.2. Messaging SUD Care to Peripartum Persons

While CTN-0080 was enrolling participants, materials to improve messaging for underserved patients, family/friends, clinicians, and other professionals involved in the care of peripartum persons with OUD were developed as part of the NIH Implementing a Maternal Health and Pregnancy Outcomes Vision for Everyone (IMPROVE) initiative. The team worked closely with NIDA, NIDA contractor Bizzell US, and persons with lived experience to develop flyers, posters, fact sheets, clinical discussion guides, patient workbook, and social media messages aimed at improving health literacy around 1) medication treatment for OUD (MOUD) during pregnancy and the postpartum period, 2) breastfeeding and MOUD, and 3) understanding one’s rights to treatment including how the Americans with Disabilities Act can protect access to MOUD. The materials are available in Spanish and in versions for different ethnic and racial groups (see National Drug Abuse Treatment Clinical Trials Network Dissemination Library).

2.5. CTN-0123 Wiidookaage’Win: Developing a Facebook program for Supporting Opioid Recovery Among American Indian Women

OUD disproportionately impacts American Indian and Alaska Native (AI/AN) adults due in part to generations of historical trauma and inequities across social determinants of health (Spencer, Garnett, & Minino, 2024; Skewes & Blume, 2019; Soto et al., 2022). The Minnesota Indian Women’s Resource Center and other Native community members identified the need to support opioid recovery among AI/AN women in Minnesota. Gender-specific interventions developed for AI/AN women in recovery from OUD did not yet exist (Barbosa-Leiker et al., 2021). Strong social support networks have been found to facilitate opioid recovery (Shanmugam, 2017), and such networks align with the AI/AN value of interdependence (Hill, 2006). A prior study found that a private, moderated Facebook group intervention was feasible and signaled efficacy for nicotine cessation among AI/AN adults (Patten et al., 2023), but the feasibility of this approach to support opioid recovery had not been studied.

2.5.1. Scope and Implementation

CTN-0123 utilized a community-based participatory research approach (CBPR) to develop a private, 3-month, moderated, culturally aligned Facebook group intervention to support opioid recovery among AI/AN women as an adjunct to MOUD. A community advisory committee of Native women with lived experience, Elders, and healthcare providers was convened to co-design the study protocol and intervention; guidance was also provided from Minnesota Tribal health leaders. An Elder Native woman named the study Wiidookaage’Win, which means “the place for help, the time of helping” in Ojibwe.

The Facebook intervention encourages acceptance and peer-based social support, addressing the role of stress/trauma in substance use, mindfulness-based relapse prevention (MBRP; Bowen et al., 2021), and Stress Management and Resiliency Training (SMART) program practices (Sood, 2019). An online landing page included local cultural and community resources to support recovery, local Native artwork, video stories, photographs, poetry, and songs focused on positive self-care and cultural reconnection. Two women (one Native) moderated the Facebook group, posting content and encouraging conversations. To develop and refine the content, qualitative work was conducted with 14 AI/AN women in recovery and 12 interested parties (e.g., AI/AN healthcare providers) followed by a 30-day beta-test of the intervention with 10 AI/AN women in recovery recruited from the Minneapolis-St. Paul, MN community.

2.5.2. Key Findings

Intervention receptivity was high. Positive words used to describe the intervention included: beautiful, connection, community, support, and strength. From content analysis, key themes were (a) the importance of reconnecting to culture for recovery, (b) media and text should resonate with AI/AN culture and strengths (e.g., positivity, resilience), and (c) the need to maintain confidentiality and build trust (Young et al., 2024). During the beta test, participants engaged (i.e., views, reactions, posts, comments, votes) a median of 33 times (range 12–98) and treatment satisfaction scores were high (Mean=4.8/5.0; range: 4.4–5.0) (Roche et al., 2024). Frequently discussed topics were managing opioid recovery, change, and interconnectedness. Open-ended feedback indicated participants felt acknowledged seeing others’ recovery stories; all expressed interest in serving as a peer moderator in future iterations of the Facebook group. All participants self-reported opioid abstinence (confirmed by urine drug screen) and continued MOUD use. Findings were shared with community partners and considered relevant and impactful for the urban Native community in Minnesota addressing an expressed community need and co-designed with AI/AN women and interested parties. A pilot RCT is currently underway to evaluate the intervention’s feasibility and potential effectiveness.

3. SECONDARY ANALYSES OF SEX DIFFERENCES IN COMPLETED CTN TRIALS

3.1. CTN-0037 STRIDE Stimulant Reduction Intervention using Dosed Exercise

In this study, participants were monitored for 36 weeks while engaging in the exercise program which included session attendance and home assignments. Overall, the study showed no difference between experimental and control arms (exercise vs. health education), and no gender differences, on the primary outcome (percent days of stimulant abstinence) (Trivedi et al. 2007). Sex differences in the effects of exercise on physiologic measures were explored (Killeen et al., 2020). Women were less likely to adhere to prescribed exercise and to achieve physical benefits. Specifically, body mass index (BMI), waist circumference (WC) and heart rate measures increased over time in women compared to reductions that were seen in men. These findings can help inform future research on gender-specific interventions that use adjunctive exercise in SUD programs.

3.2. CTN-0051 Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment

GSIG members leveraged data from a 24-week open-label randomized comparative effectiveness study of buprenorphine vs. extended-release naltrexone among people (N=570) with OUD (Lee et al., 2018) to produce three analyses focused on gender differences: baseline characteristics (Campbell, et al., 2018), substance use and mental health in older and younger men and women (Barbosa-Leiker et al., 2020), and clinical and psychosocial outcomes by sex (Paschen-Wolff et al., 2023). Given the relative paucity of literature specific to women receiving MOUD, these analyses contributed meaningful information leveraging a large community-based dataset.

A paper on baseline data demonstrated that women were significantly younger, had greater economic vulnerability and psychiatric comorbidity, and greater prevalence of sexual and physical abuse histories, versus men. In an analysis comparing older versus emerging adults by sex, differences in clinical characteristics by age were similar for men and women. One finding of note, older women reported more mental health problems compared to younger women, while younger men reported greater mental health problems compared to older men. Finally, in an analysis reporting psychosocial outcomes among a subsample of participants who successfully initiated onto the medications, women randomized to extended-release naltrexone had greater odds of employment at 6-month follow-up versus those randomized to buprenorphine. Together, these findings have implications for tailoring interventions and ancillary services for women (and men) with OUD. Further, these analyses illuminate subgroups of women who may need specific vocational, mental health, and physical health services to enhance the effectiveness of SUD care.

4. RESEARCH NEEDS TO IMPROVE TREATMENT FOR WOMEN WITH SUD

4.1. Beyond Sex as a Dichotomous Predictor of Outcome

While sex alone has not been found to predict SUD treatment outcomes, there are important characteristics of individuals and subgroups of individuals that may differentially affect treatment and other quality of life outcomes (McHugh et al., 2018; Sugarman et al., 2017). For example, as noted previously in secondary analyses of CTN-0051, the main outcome showed no significant sex differences in successful initiation onto either medication (Lee et al., 2018). However, subsequent analyses found that females successfully initiated onto extended-release naltrexone had significantly greater odds of employment at 6-month follow-up compared with females successfully initiated onto buprenorphine-naloxone (Paschen-Wolff et al., 2023). Extended-release naltrexone requires less treatment burden, as it is dispensed by monthly injection, which may have made employment opportunities easier for women who tend to have competing responsibilities on their time (e.g., childcare, caring for elders). This finding suggests there is a need to reduce barriers to employment for women. Examining sex as a dichotomous independent predictor of treatment outcome obscures findings such as these. It will be important that future studies incorporate analyses that account for factors that vary by sex/gender, for example: socioeconomic characteristics (e.g., educational attainment, employment, dependent children), marital status, co-occurring psychiatric disorders (e.g., depression, anxiety, PTSD), and history of trauma. See Table 2 for research recommendations.

TABLE 2:

Research Recommendations for NIDA Clinical Trials Network (CTN) and Other Substance Use Disorder (SUD) Treatment Research

RECOMMENDATIONS IMPLEMENTATION STRATEGIES
1. Future CTN trials should systematically and consistently measure sex/gender assigned at birth, gender, and sexual identity. • Systematically employ the Gender Special Interest Group-developed sexual orientation or gender identity measures (based on existing recommendations and tools from the National Academies of Sciences, Engineering, and Medicine, the National LGBTQIA+ Health Education Center (National LGBTQIA+ Health Education Center: a program of the Fenway Institute), and the PhenX Toolkit) in all CTN trials.
2. CTN investigators should design trials that account for intersectionality from concept to measures development to study recruitment. • Employ novel and community-based recruitment strategies to recruit appropriately sized samples of racial, ethnic, and sexual and gender minority populations to examine both intra- and intergroup differences in treatment response.
• Collaborate with diverse community partners from study beginning to end, using community-based participatory research methods to build community trust (Israel et al., 1998; 2005; LaVeaux et al., 2009).
3. Future CTN analyses on gender differences should account for factors that vary by gender and that may impact treatment outcomes. • Examples of factors that vary by gender: Age, socioeconomic characteristics (e.g., educational attainment, employment, dependent children); marital status; co-occurring psychiatric disorders (e.g., depression, anxiety, posttraumatic stress disorder); and history of trauma.
4. To address the challenge of recruiting an adequate sample of participants that are diverse with respect to gender, age, race, and ethnicity, CTN investigators should consider employing an innovative methodology that combines data from multiple studies. • Example of innovative methodology: Project Harmony (Saavedra et al., 2021; Hien et al., 2024) which harmonized and analyzed data from over 40 independent trials. This methodology can enlarge sample size, address measurement variation, increase population diversity, and boost statistical power.
5. Future CTN trials should use an appropriate timeline of outcomes, which is also important in study design. • Example of an appropriate timeline: In CTN-0015 Women & Trauma Study, more distal follow-up timepoints allowed for examination of the temporal association between posttraumatic stress disorder and substance use improvement (Hien et al., 2010).
6. Future CTN trials should include reproductive health measures as part of their assessment batteries. • Research is needed on understudied reproductive health topics, such as the effect of perimenopause and menopause on substance use.
• Include assessments of menstrual history inclusive of menstrual pain and menstrual cycle-related mood changes.
• Examine the role of reproductive health in substance use including pregnancies, miscarriages, termination of pregnancies, and parenting.
7. Research is needed on effective interventions for perinatal and postpartum periods; work which the CTN is well-situated to conduct • Design and test delivery models that improve perinatal and postpartum substance use disorder identification, treatment, communication, and care coordination.
• Test and implement interventions to reduce inappropriate triggering circumstances and severity of penalties for pregnant people who use substances.
• Develop shared decision-making tools for patients and providers with evidence on risks and alternatives to substance use.
• Develop and test interventions that target common reasons for perinatal cannabis use that have potential to alleviate maternal suffering, reduce use and associated harms.
Open in a new tab

4.2. Intersectional and Marginalized Identities

Women with marginalized identities, like women of color (Mereish et al., 2014; Mereish et al., 2023; SAMHSA, 2019) and sexual and gender minority (SGM) women (Hughto et al., 2021; Keuroghlian et al., 2015), experience disproportionately high rates of SUD compared to white, heterosexual, and cisgender women due in part to identity-related stressors and using substances as a coping mechanism (Brooks et al., 1981; Hendricks et al., 2012; Meyer et al., 2003). Stigma and discrimination intensify rates of substance use and SUD among women with intersecting marginalized identities (Mereish et al., 2014; Mereish et al., 2023; Pachankis et al., 2020). Intersectional stigma can also present additional barriers to accessing SUD treatment (Flentje et al., 2016; Matsuzaka et al., 2020). Perceived stigma can inhibit disclosure of risky substance use to health care providers, resulting in missed opportunities for linkage to treatment (McNeely et al., 2018). Gender-specific interventions that account for intersectional stigma and discrimination among women need to address SUD disparities and barriers to SUD treatment and may be more acceptable and effective among women (Matsuzaka et al., 2020; McHugh et al., 2018; Thompson et al., 2016). Despite these findings, existing interventions to reduce structural stigma toward people who use drugs have not addressed the intersections of sexism, racism, homophobia, or transphobia (Livingston et al., 2012).

The CTN has led numerous large, multisite clinical trials, but few have consistently or systematically measured sexual orientation or gender identity (SOGI). When SOGI has been measured in CTN studies, sample sizes of LGBTQ+ populations have often been too small to compare substance use outcomes by SOGI (e.g., Campbell et al., 2018; Paschen-Wolff et al., 2025). Without consistent and robust data on SOGI, investigators will be challenged to systematically examine substance use outcomes in LGBTQ+ communities or develop and assess effectiveness of potentially affirming SUD interventions.

It will be important that (1) future CTN and other SUD trials systematically and consistently measure sex/gender assigned at birth and gender and sexual identity; and (2) investigators design trials that account for intersectionality, including in measures development and targeted recruitment. In 2023, the CTN GSIG collaboratively compiled measures to assess SOGI based on existing recommendations and tools from the National Academies of Sciences, Engineering, and Medicine (2022), the National LGBTQIA+ Health Education Center (2022), and the PhenX Toolkit (Hamilton et al., 2011). It is also recommended that studies employ novel and community-based recruitment strategies to increase engagement and recruitment of SGM populations to examine both intra- and intergroup differences in substance use outcomes (e.g., substance use among LGBTQ+ people of color compared to white LGBTQ+ people). Further, trials may consider collaborations with diverse LGBTQ+ community partners in all stages of the research using CBPR research methods to enhance community trust (Israel et al., 2005; Israel et al., 1998; LaVeaux et al., 2009).

4.3. Sample Size and Study Design Considerations

The interaction between certain baseline characteristics (e.g., age, race, ethnicity) and sex or gender is often not examined in clinical trials because most treatment outcome studies do not have adequate sample sizes to conduct these statistical tests. Employing innovative methodologies that combine data from multiple studies may be one approach to examine the interaction of these characteristics on outcomes. One example is Project Harmony (Hien et al., 2024; Saavedra et al., 2021), which harmonized and analyzed data from over 40 independent trials. This type of methodology enlarges the sample size, addresses measurement variation, increases population diversity, and boosts statistical power.

Choosing the appropriate timeline for assessing specific outcomes is also critical. For example, in the WTS (CTN-0015), more distal follow-up timepoints allowed for examination of temporal association between PTSD and substance use improvement (Hien et al., 2010). When timepoints are more proximal, key effects of interventions that take longer to manifest can be missed.

4.4. Menstrual Cycle and Reproductive Health Assessments in Clinical Trails

Menstrual pain (i.e., dysmenorrhea), a disabling condition affecting up to 90% of reproductive age girls and women, is associated with disruptions in daily life (e.g., missed school and work) and can negatively impact quality of life, sleep, and mood (MacGregor et al., 2023). Menstrual pain can put individuals at risk for substance misuse; heavy drinking, cigarette smoking, and cannabis use have all been linked to menstrual pain (Wilsnack et al., 1984; Qin et al., 2020; Sinclair et al., 2023). Evidence also suggests that menstrual cycle characteristics can have important influences on substance use behaviors (Joyce, Good, et al. 2021), including increased substance use among individuals experiencing premenstrual dysphoric disorder or premenstrual syndrome (Joyce, Good, et al., 2021) and negative affect across the menstrual cycle (Joyce, Thompson et al., 2021). To develop targeted interventions, it is important to understand the potential mechanisms (e.g., pain, negative affect) that link menstrual cycle phases to substance use, as well as individual differences in cycle-related fluctuations in substance use risks. Further, SUD research should include assessments of menstrual history, including menstrual pain and menstrual cycle-related mood changes. Understanding the role of reproductive health in substance use is also important (i.e., pregnancies, miscarriages, termination of pregnancies, parenting) and clinical trials should include reproductive health measures as part of the assessment. Finally, research on understudied topics, such as the effect of perimenopause and menopause on substance use, is long overdue.

4.5. Pregnancy, Postpartum, and Parenting

Drug overdose and suicide combined constitute the leading cause of maternal mortality during pregnancy or the postpartum year in the U.S. with most (80–100%) of these deaths determined to be preventable (Han et al., 2024; Trost et al., 2022; ACIMM, 2024). Factors contributing to these deaths are primarily attributable to a failure of detection and treatment engagement, and lack of communication and care coordination (ACIMM, 2024). National organizations recommend universal screening and referral to treatment for perinatal SUDs and mental health conditions (ACOG, 2015; ACP, 2022; Clarke, De Faria, & Alpert, 2023), but most women are not screened (80–90%) (Moyer, 2013; Krist et al., 2020; Hermann et al., 2019; Bauman et al., 2018) and do not receive treatment (75–80%) (Byatt et al., 2015; Martino et al., 2018). Importantly, care coordination must include overcoming extensive social and structural determinants of health that impede access to resources and treatment (Clear-Perry et al., 2021; APA, 2023). Integrated treatment programs that target women-specific perinatal SUD issues (e.g., prenatal care, addiction, mental health, parenting, employment, childcare) are optimal for maternal and child health outcomes, however barriers to implementation persist (Moreland & McRae-Clark, 2018; Berman et al., 2022). Designing, testing, and disseminating optimal patient- and provider-informed healthcare delivery models that improve perinatal SUD identification, treatment and communication and care coordination during pregnancy and the postpartum year are greatly needed (Echols et al., 2023; Guille et al., 2024).

Most women with perinatal SUDs (83%) will abstain from substance use in pregnancy, but 80% will return to use within 4.5 months postpartum (Forray et al, 2015), increasing risk for overdose and death (60% of maternal overdose deaths occur 7–12 months postpartum; Han et al., 2024). Identifying, developing, and testing interventions to be delivered in late pregnancy or early postpartum targeting potential mediating (i.e., social determinants of health, trauma, stress, sleep, pain) (Pardo et al., 2024; Skelton et al., 2020) or moderating factors (i.e., discontinuation of effective medications for SUD and mental health disorders) (Schiff et al., 2021; Trinh et al., 2023) that contribute to substance use may decrease the risk of return to substance use during this critical window. Even when services are available to pregnant and postpartum individuals, stigma and discrimination, particularly among minority and disadvantaged populations (Weber et al., 2021), are barriers. The role of community health workers, peer recovery specialists, and community doulas in reducing stigma and facilitating recovery is another area of recent research interest (Gannon et al. 2024).

Stigma and discrimination are further compounded by punitive laws in response to perinatal substance use which have increased in recent years; 25 states now enforce criminalization (e.g., homicide manslaughter), termination of parental rights, involuntary commitment to treatment, and/or charges of child abuse or neglect and/or in response to perinatal substance. These laws persist despite well-established maternal, fetal and newborn harms associated with adoption of these laws (Bruzelius et al., 2024). Policy work is needed to amend these laws in ways that protect women and children’s health. In the meantime, testing and implementing interventions to decrease the inappropriate and dramatic variability in the triggering circumstances and severity of penalties within and between states are needed.

Cannabis is the most used illicit substance during pregnancy and is associated with a host of poor maternal and child outcomes (Hayes, Delker & Bandoli, 2023). Its increasing use during pregnancy and postpartum is complicated by public perception of purported health benefits, medical and recreational legalization, and the misperception that cannabis is natural and therefore harmless (Chernek & Skelton, 2022; Jarlenski et al., 2017). Despite professional organizations discouraging cannabis use (ACOG, 2017), providers often feel ill-equipped to counsel patients (Kitsantas & Pursell, 2024). Shared decision-making tools for patients and providers with up-to-date evidence on the risks and alternatives to use are greatly needed to promote informed decision-making (Guille et al., 2019). Additionally, developing and testing interventions that target common reasons for perinatal cannabis use (e.g., poor sleep, nausea, anxiety) (Weisbeck et al., 2021) have the potential to both alleviate maternal suffering and reduce cannabis use and its associated harms.

5. CONCLUSION

The prevalence of substance use and SUDs in women is steadily increasing, and the gender prevalence ratio is narrowing across substances, with prevalence rates in adolescent girls exceeding that of boys (SAMHSA, 2023). Women are a heterogeneous population who face unique clinical vulnerabilities, including faster progression to dependence and physiological harm, higher rates of co-occurring psychiatric disorders, and considerable medical and social consequences of substance use. However, existing substance use research and non-specialized treatment programs do not adequately address these distinct clinical factors, presenting a significant barrier to effective SUD treatment. It is imperative that SUD research considers the unique needs of women and other gender diverse people to continue to develop and deliver effective, patient-centered treatment. Supporting and prioritizing focused workgroups and other bodies, like the NIDA CTN GSIG, that hold expertise and experience in these areas is a critical way to continue to build upon these efforts.

Acknowledgements:

The authors are indebted to Carmen L. Rosa, MS (retired), for her leadership within the Clinical Trials Network and Gender Special Interest Group. She tirelessly promoted science and scholarship aimed towards improving the health outcomes of women and others underrepresented and/or under resourced in addiction research and treatment. The authors also acknowledge the many research participants and community partners that undertake and promote research in support of the wellbeing of others.

Funding:

The research trial data reported, as well as historical work of the Clinical Trials Network Gender Special Interest Group described in this manuscript, was supported in part by grants from the National Institutes of Health, National Institute on Drug Abuse (NIDA): UG1DA013035 (MPIs: McNeely, Nunes, Campbell); UG1DA015831 (MPIs: Weiss, D’Onofrio); UG1DA049468 (PI: Grando, Page); UG1DA013732 (PI: Winhusen); UG1DA013727 (MPIs: Barth, Brady); UG1DA040316 (PI: Bart); K23DA05078 (PI: Sugarman).

Footnotes

Disclaimer: The content of this manuscript is solely the responsibilities of the authors and does not necessarily represent the official views of the National Institutes of Health or institutional affiliations of the authors.

Note: In this paper, the terms, “women” and “woman” refer to anyone who identifies as a woman (including transgender and cisgender women), regardless of their sex or gender assigned at birth. When describing “gender-specific” interventions, these refer to interventions tailored to women’s needs and experiences (inclusive of transgender and cisgender women) based on their gender and other intersectional identities (e.g., sexual orientation, race, ethnicity, transgender experience). “Sex” refers to individuals’ sex assigned at birth based on their genitalia and/or chromosomes. Some studies do not specify whether gender identity and/or sex were assessed and some only assessed sex. As such, we use the term, “sex” when citing data or studies that only measured sex but not gender identity. When reporting data, we have retained terminology used in the original trials’ publications.

REFERENCES

  1. Advisory Committee on Infant and Maternal Mortality (ACIMM). (2024). Pregnancy-related deaths: Data from maternal mortality review committees in 36 U.S. states, 2017–2019. Retrieved from https://www.cdc.gov/maternal-mortality/php/data-research/mmrc-2017-2019.html [Google Scholar]
  2. Agterberg S, Schubert N, Overington L, & Corace K (2020). Treatment barriers among individuals with co-occurring substance use and mental health problems: Examining gender differences. Journal of Substance Abuse Treatment, 112, 29–35. 10.1016/j.jsat.2020.01.005 [DOI] [PubMed] [Google Scholar]
  3. American Academy of Pediatrics. (2022). Perinatal mental health and social support. Retrieved from https://www.aap.org/en/patient-care/perinatal-mental-health-and-social-support [Google Scholar]
  4. American College of Obstetricians and Gynecologists (ACOG). (2017). Marijuana use during pregnancy and lactation. Committee Opinion No. 722. https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2017/10/marijuana-use-during-pregnancy-and-lactation [Google Scholar]
  5. American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins—Obstetrics (ACOG). (2015). ACOG Practice Bulletin No. 633: Alcohol abuse and other substance use disorders: Ethical issues in obstetric and gynecologic practice. Obstetrics & Gynecology, 125(6), 1529–1537. 10.1097/01.AOG.0000466371.86393.9b [DOI] [PubMed] [Google Scholar]
  6. American Psychiatric Association. (2023). Perinatal mental health and substance use disorders. Retrieved from https://www.psychiatry.org/getmedia/344c26e2-cdf5-47df-a5d7-a2d444fc1923/APA-CDC-Perinatal-Mental-and-Substance-Use-Disorders-Whitepaper.pdf [Google Scholar]
  7. Back SE (2010). Toward an improved model of treating co-occurring PTSD and substance use disorders. The American Journal of Psychiatry, 167(1), 11–13. 10.1176/appi.ajp.2009.09111602 [DOI] [PMC free article] [PubMed] [Google Scholar]
  8. Bahji A, Mazhar MN, Hudson CC, Nadkarni P, MacNeil BA, & Hawken E (2019). Prevalence of substance use disorder comorbidity among individuals with eating disorders: A systematic review and meta-analysis. Psychiatry Research, 273, 58–66. 10.1016/j.psychres.2019.01.007 [DOI] [PubMed] [Google Scholar]
  9. Barbosa-Leiker C, Campbell ANC, McHugh RK, Guille C, & Greenfield SF (2021). Opioid use disorder in women and the implications for treatment. Psychiatric Research and Clinical Practice, 3(1), 3–11. 10.1176/appi.prcp.20190051 [DOI] [PMC free article] [PubMed] [Google Scholar]
  10. Barbosa-Leiker C, Campbell ANC, Pavlicova M, Scodes J, Burlew AK, Hatch-Maillette M, Mennenga SE, Mitchell SG, Novo P, Nunes EV, Rotrosen J, & Greenfield SF (2020). Substance use and mental health in emerging adult vs older adult men and women with Opioid Use Disorder. The American Journal on Addictions, 29(6), 536–542. 10.1111/ajad.13059 [DOI] [PMC free article] [PubMed] [Google Scholar]
  11. Bauman BL, Ko JY, Cox S, D’Angelo Mph DV, Warner L, Folger S, Tevendale HD, Coy KC, Harrison L, & Barfield WD (2020). Vital signs: Postpartum depressive symptoms and provider discussions about perinatal depression - United States, 2018. MMWR. Morbidity and Mortality Weekly Report, 69(19), 575–581. 10.15585/mmwr.mm6919a2 [DOI] [PMC free article] [PubMed] [Google Scholar]
  12. Berman JS, Dobbins E, Theis E, Murray M, & Stockdale H (n.d.). Integrating OB/GYN and SUD care: Policy challenges and opportunities. National Library of Medicine. https://collections.nlm.nih.gov/catalog/nlm:nlmuid-9918367883906676-pdf [Google Scholar]
  13. Bowen S, Chawla N, Grow J, & Marlatt GA (2021). Mindfulness-based Relapse Prevention for Addictive Behaviors: A Clinician’s Guide. Guilford Press. [Google Scholar]
  14. Brady KT (1997). Posttraumatic stress disorder and comorbidity: Recognizing the many faces of PTSD. The Journal of Clinical Psychiatry, 58(S9), 12–15. [PubMed] [Google Scholar]
  15. Brewerton TD, & Brady K (2014). The role of stress, trauma, and PTSD in the etiology and treatment of eating disorders, addictions, and substance use disorders. In Brewerton TD & Baker DA (Eds.), Eating Disorders, Addictions and Substance Use Disorders: Research, Clinical and Treatment Perspectives (pp. 379–404). Springer; Berlin Heidelberg. 10.1007/978-3-642-45378-6_17 [DOI] [Google Scholar]
  16. Brooks AJ, Lokhnygina Y, Meade CS, Potter JS, Calsyn DA, & Greenfield SF (2013). Racial/ethnic differences in the rates and correlates of HIV risk behaviors among drug abusers. The American Journal on Addictions, 22(2), 136–147. 10.1111/j.1521-0391.2013.00303.x [DOI] [PMC free article] [PubMed] [Google Scholar]
  17. Brooks VR (1981). Minority Stress and Lesbian Women. Lexington Books, D.C. Health and Co. [Google Scholar]
  18. Bruzelius E, Underhill K, Askari MS, Kajeepeta S, Bates L, Prins SJ, Jarlenski M, & Martins SS (2024). Punitive legal responses to prenatal drug use in the United States: A survey of state policies and systematic review of their public health impacts. International Journal of Drug Policy, 126, 104380. 10.1016/j.drugpo.2024.104380 [DOI] [PMC free article] [PubMed] [Google Scholar]
  19. Burlew AK, McCuistian C, & Lanaway D (2023). Culturally adapted safer sex skills building: Development and initial testing of an HIV prevention intervention for Black women using substances in the United States. Health Education Research, 38(6), 527–536. 10.1093/her/cyad037. [DOI] [PubMed] [Google Scholar]
  20. Byatt N, Levin LL, Ziedonis D, Moore Simas TA, & Allison J (2015). Enhancing participation in depression care in outpatient perinatal care settings: A systematic review. Obstetrics and Gynecology, 126(5), 1048–1058. 10.1097/AOG.0000000000001067 [DOI] [PMC free article] [PubMed] [Google Scholar]
  21. Campbell ANC, & Greenfield SF (2024). Post-Dobbs challenges in research and patient protections. JAMA Psychiatry, 81(6), 535–536. 10.1001/jamapsychiatry.2024.0598 [DOI] [PubMed] [Google Scholar]
  22. Campbell ANC, Barbosa-Leiker C, Hatch-Maillette M, Mennenga SE, Pavlicova M, Scodes J, Saraiya T, Mitchell SG, Rotrosen J, Novo P, Nunes EV, & Greenfield SF (2018). Gender differences in demographic and clinical characteristics of patients with opioid use disorder entering a comparative effectiveness medication trial. The American Journal on Addictions, 27(6), 465–470. 10.1111/ajad.12784 [DOI] [PMC free article] [PubMed] [Google Scholar]
  23. Center for Behavioral Health Statistics and Quality. (2021). Racial/ethnic differences in mental health service use among adults and adolescents (2015–2019) (Publication No. PEP21-07-01-002). Rockville, MD: Substance Abuse and Mental Health Services Administration. Retrieved from https://www.samhsa.gov/data [Google Scholar]
  24. Chernek BA, & Skelton KR (2022). Attitudes toward cannabis use during labor in the United States. Womens Health Reports, 3(1), 124–130. 10.1089/whr.2021.0125 [DOI] [PMC free article] [PubMed] [Google Scholar]
  25. Clarke DE, De Faria L, Alpert JE, The Perinatal Mental Health Advisory Panel, & The Perinatal Mental Health Research Team. (2023). Perinatal Mental and Substance Use Disorder: White Paper. Washington, DC: American Psychiatric Association. Retrieved from https://www.psychiatry.org/maternal [Google Scholar]
  26. Cohen LR, Greenfield SF, Gordon S, Killeen T, Jiang H, Zhang Y, & Hien D (2010). Survey of eating disorder symptoms among women in treatment for substance abuse. American Journal of Addiction, 19(3), 245–251. 10.1111/j.1521-0391.2010.00038.x [DOI] [PMC free article] [PubMed] [Google Scholar]
  27. Crear-Perry J, Correa-de-Araujo R, Lewis Johnson T, McLemore MR, Neilson E, & Wallace M (2021). Social and structural determinants of health inequities in maternal health. Journal of Women’s Health, 30(2), 230–235. 10.1089/jwh.2020.8682 [DOI] [PMC free article] [PubMed] [Google Scholar]
  28. Diehl A, Croissant B, Batra A, Mundle G, Nakovics H, & Mann K (2007). Alcoholism in women: is it different in onset and outcome compared to men? European Archives of Psychiatry and Clinical Neuroscience, 257(6), 344–351. 10.1007/s00406-007-0737-z [DOI] [PubMed] [Google Scholar]
  29. Echols A, Collins S, Akbarali S, Dronamraju R, & Uesugi K (2023). Public health approaches to perinatal substance use: An overview of strategic directions. Maternal and Child Health Journal, 27(S1), 1–4. 10.1007/s10995-023-03792-4 [DOI] [PMC free article] [PubMed] [Google Scholar]
  30. Falzarano M, & Pinto Zipp G (2013). Seeking consensus through the use of the Delphi technique in health sciences research. Journal of Allied Health, 42(2), 99–105. [PubMed] [Google Scholar]
  31. Flentje A, Livingston NA, & Sorensen JL (2016). Meeting the needs of lesbian, gay, and bisexual clients in substance abuse treatment. Counselor, 17(3), 54–59. [PMC free article] [PubMed] [Google Scholar]
  32. Food and Drug Administration, U.S. Department of Health and Human Services. (1993). Guidelines for the study and evaluation of gender differences in the clinical evaluation of drugs. Federal Register, 58, 39406–39416. [PubMed] [Google Scholar]
  33. Food and Drug Administration, U.S. Department of Health and Human Services. (1994). Guidelines on the inclusion of women and minorities as subjects in clinical research. NIH Guide, 23. [Google Scholar]
  34. Forray A, Merry B, Lin H, Ruger JP, & Yonkers KA (2015). Perinatal substance use: A prospective evaluation of abstinence and relapse. Drug and Alcohol Dependence, 150, 147–155. 10.1016/j.drugalcdep.2015.02.027 [DOI] [PMC free article] [PubMed] [Google Scholar]
  35. Gannon M, Short V, Keith S, Hand D, Oliner LO, Yang A, Haerizadeh-Yazdi N, Ize-Iyamu A, Kelly E, Weinstein L, Goyal N, Jeminiwa R, & Abatemarco D (2024). Scarce perinatal social support for women with OUD: Opportunities for doula services. Midwifery, 138, 104169. 10.1016/j.midw.2024.104169 [DOI] [PubMed] [Google Scholar]
  36. Gentilello LM, Rivara FP, Donovan DM, Villaveces A, Daranciang E, Dunn CW, & Ries RR (2000). Alcohol problems in women admitted to a level I trauma center: a gender-based comparison. The Journal of Trauma, 48(1), 108–114. 10.1097/00005373-200001000-00018. [DOI] [PubMed] [Google Scholar]
  37. Gordon SM, Johnson JA, Greenfield SF, Cohen L, Killeen T, & Roman PM (2008). Assessment and treatment of co-occurring eating disorders in publicly funded addiction treatment programs. Psychiatric Services, 59(9), 1056–1059. 10.1176/ps.2008.59.9.1056 [DOI] [PMC free article] [PubMed] [Google Scholar]
  38. Grant BF, Chou SP, Saha TD, Pickering RP, Kerridge BT, Ruan WJ, Huang B, Jung J, Zhang H, Fan A, & Hasin DS (2017). Prevalence of 12-Month alcohol use, high-risk drinking, and DSM-IV Alcohol Use Disorder in the United States, 2001–2002 to 2012–2013: Results from the National Epidemiologic Survey on Alcohol and Related Conditions. JAMA psychiatry, 74(9), 911–923. 10.1001/jamapsychiatry.2017.2161. [DOI] [PMC free article] [PubMed] [Google Scholar]
  39. Greenfield SF, Back SE, Lawson K, & Brady KT (2010). Substance abuse in women. The Psychiatric Clinics of North America, 33(2), 339–355. 10.1016/j.psc.2010.01.004. [DOI] [PMC free article] [PubMed] [Google Scholar]
  40. Greenfield SF, Brooks AJ, Gordon SM, Green CA, Kropp F, McHugh RK, Lincoln M, Hien D, & Miele GM (2007). Substance abuse treatment entry, retention, and outcome in women: a review of the literature. Drug and Alcohol Dependence, 86(1), 1–21. 10.1016/j.drugalcdep.2006.05.012. [DOI] [PMC free article] [PubMed] [Google Scholar]
  41. Greenfield SF, Sugarman DE, Freid CM, Bailey GL, Crisafulli MA, Kaufman JS, Wigderson S, Connery HS, Rodolico J, Morgan-Lopez AA, & Fitzmaurice GM (2014). Group therapy for women with substance use disorders: results from the Women’s Recovery Group Study. Drug and Alcohol Dependence, 142, 245–253. 10.1016/j.drugalcdep.2014.06.035. [DOI] [PMC free article] [PubMed] [Google Scholar]
  42. Guille C, Jones HE, Abuhamad A, & Brady KT (2019). Shared decision-making tool for treatment of perinatal Opioid Use Disorder. Psychiatric Research and Clinical Practice, 1(1), 27–31. 10.1176/appi.prcp.20180004 [DOI] [PMC free article] [PubMed] [Google Scholar]
  43. Guille C, King C, King K, Kruis R, Ford D, Maldonado L, Nietert PJ, Brady KT, & Newman RB (2024). Text and telephone screening and referral improved detection and treatment of maternal mental health conditions. Health Affairs, 43(4), 548–556. 10.1377/hlthaff.2023.01432 [DOI] [PMC free article] [PubMed] [Google Scholar]
  44. Habersham LL, Townsel C, Terplan M, & Hurd YL (2025). Substance use and use disorders during pregnancy and the postpartum period. Americna Journal of Obstetrics and Gynecology, 232(4), 337–353. 10.1016/j.ajog.2025.01.007 [DOI] [PubMed] [Google Scholar]
  45. Hamilton CM, Strader LC, Pratt JG, Maiese D, Hendershot T, Kwok RK, Hammond JA, Huggins W, Jackman D, Pan H, Nettles DS, Beaty TH, Farrer LA, Kraft P, Marazita ML, Ordovas JM, Pato CN, Spitz MR, Wagener D, Williams M, … Haines J (2011). The PhenX Toolkit: Get the most from your measures. American Journal of Epidemiology, 174(3), 253–260. 10.1093/aje/kwr193 [DOI] [PMC free article] [PubMed] [Google Scholar]
  46. Han B, Compton WM, Einstein EB, Elder E, & Volkow ND (2024). Pregnancy and postpartum drug overdose deaths in the US before and during the COVID-19 pandemic. JAMA Psychiatry, 81(3), 270–283. 10.1001/jamapsychiatry.2023.4523 [DOI] [PMC free article] [PubMed] [Google Scholar]
  47. Hayes S, Delker E, & Bandoli G (2023). The prevalence of cannabis use reported among pregnant individuals in the United States is increasing, 2002–2020. Journal of Perinatology, 43(3), 387–389. 10.1038/s41372-022-01550-y. [DOI] [PMC free article] [PubMed] [Google Scholar]
  48. Helzer JE, Burnam A, & McEvoy LT (1991). Alcohol abuse and dependence. In Robins LN & Regier DA (Eds.), Psychiatric Disorders in America: The Epidemiological Catchment Area Study (pp. 81–115). The Free Press. [Google Scholar]
  49. Hendricks ML, & Testa RJ (2012). A conceptual framework for clinical work with transgender and gender nonconforming clients: An adaptation of the minority stress model. Professional Psychology: Research and Practice, 43(5), 460–467. 10.1037/a0029597 [DOI] [Google Scholar]
  50. Henskens R, Mulder CL, Garretsen H, Bongers I, & Sturmans F (2005). Gender differences in problems and needs among chronic, high-risk crack abusers: Results of a randomized controlled trial. Journal of Substance Use, 10(2–3), 128–140. 10.1080/14659890412331336444. [DOI] [Google Scholar]
  51. Hermann A, Karabell S, Greiner M, Jackson T, & Saxon A. (2019). Position statement on assuring the appropriate care of pregnant and newly delivered women with substance use disorders [position statement]. American Psychiatric Association. [Google Scholar]
  52. Hernandez-Avila CA, Rounsaville BJ, & Kranzler HR (2004). Opioid-, cannabis- and alcohol-dependent women show more rapid progression to substance abuse treatment. Drug and alcohol dependence, 74(3), 265–272. 10.1016/j.drugalcdep.2004.02.001 [DOI] [PubMed] [Google Scholar]
  53. Hien D, Litt L, & Cohen LR (2019). Seeking Safety: A present-focused integrated treatment for PTSD and substance use disorders (pgs. 183–207). In Vujanovic AA, & Back SE (Eds.). (2019). Posttraumatic Stress and Substance Use Disorders: A Comprehensive Clinical Handbook. Routledge. [Google Scholar]
  54. Hien DA, Campbell ANC, Ruglass LM, Saavedra L, Matthews AG, Kiriakos G, & Morgan-Lopez A (2015). Maximizing effectiveness trials in PTSD and SUD through secondary analysis: Benefits and limitations using the National Institute on Drug Abuse Clinical Trials Network “Women and Trauma” study as a case example. Journal of Substance Abuse Treatment, 56, 23–33. 10.1016/j.jsat.2015.04.001 [DOI] [PMC free article] [PubMed] [Google Scholar]
  55. Hien DA, Campbell AN, Killeen T, Hu MC, Hansen C, Jiang H, Hatch-Maillette M, Miele GM, Cohen LR, Gan W, Resko SM, DiBono M, Wells EA, & Nunes EV (2010). The impact of trauma-focused group therapy upon HIV sexual risk behaviors in the NIDA Clinical Trials Network “Women and trauma” multi-site study. AIDS and Behavior, 14(2), 421–430. 10.1007/s10461-009-9573-7 [DOI] [PMC free article] [PubMed] [Google Scholar]
  56. Hien DA, Cohen LR, & Campbell ANC (2009). Methodological innovation to increase the utility and efficiency of psychotherapy research for patients with co-occurring mental health and substance use disorders. Professional Psychology: Research and Practice, 40(5), 502–509. 10.1037/a0014966 [DOI] [PMC free article] [PubMed] [Google Scholar]
  57. Hien DA, Cohen LR, Miele GM, Litt LC, & Capstick C (2004). Promising treatments for women with comorbid PTSD and substance use disorders. American Journal of Psychiatry, 161(8), 1426–1432. 10.1176/appi.ajp.161.8.1426 [DOI] [PubMed] [Google Scholar]
  58. Hien DA, Morgan-López AA, Saavedra LM, Ruglass LM, Ye A, Lopez-Castro T, Fitzpatrick S, Killeen T, Norman SB, Ebrahimi CT, & Back SE (2023). Project Harmony: A meta-analysis with individual patient data on behavioral and pharmacologic trials for comorbid posttraumatic stress and alcohol or other drug use disorders. American Journal of Psychiatry, 180(2), 155–166. 10.1176/appi.ajp.22010071 [DOI] [PMC free article] [PubMed] [Google Scholar]
  59. Hien DA, Papini S, Saavedra LM, Bauer AG, Ruglass LM, Ebrahimi CT, Fitzpatrick S, Lopez-Castro T, Norman SB, Killeen TK, Back SE, & Morgan-Lopez AA (2024). Project Harmony: A systematic review and network meta-analysis of psychotherapy and pharmacologic trials for comorbid posttraumatic stress, alcohol, and other drug use disorders. Psychological Bulletin, 150(3), 319–353. 10.1037/bul0000409 [DOI] [PMC free article] [PubMed] [Google Scholar]
  60. Hien DA, Wells EA, Jiang H, Suarez-Morales L, Campbell ANC, Cohen LR Miele GM, Killeen T, Brigham GS, Zhang Y, Hansen C, Hodgkins C, Hatch-Maillette M, Brown C, Kulaga A, Kirstman-Valente A, Chu M, Sage R, Robinson JA, Liu D, & Nunes EV (2009). Multisite randomized trial of behavioral interventions for women with co-occurring PTSD and substance use disorders. Journal of Consulting and Clinical Psychology, 77(4), 607–619. 10.1037/a0016227 [DOI] [PMC free article] [PubMed] [Google Scholar]
  61. Hien D, Kropp F, Wells EA, Campbell ANC, Hatch-Maillette M, Hodgkins C, Killeen T, Lopez-Castro T, Morgan-Lopez A, Ruglass LM, Saavedra L, & Nunes EV (2020). The “Women and Trauma” study and its national impact on advancing trauma-specific approaches in community substance use treatment and research. Journal of Substance Abuse Treatment, 112, 12–17. 10.1016/j.jsat.2020.02.003 [DOI] [PMC free article] [PubMed] [Google Scholar]
  62. Hien D, Litt LC, Cohen LR, Miele GM, & Campbell A (2009). Moving research to practice: Three community-based examples of concurrent trauma and substance abuse treatment. In Trauma Services for Women in Substance Abuse Treatment: An Integrated Approach (pp. 199–222). 10.1037/11864-011 [DOI] [Google Scholar]
  63. Hill DL (2006). Sense of belonging as connectedness, American Indian worldview, and mental health. Archives of Psychiatric Nursing, 20(5), 210–216. 10.1016/j.apnu.2006.04.003 [DOI] [PubMed] [Google Scholar]
  64. Hughto JMW, Quinn EK, Dunbar MS, Rose AJ, Shireman TI, & Jasuja GK (2021). Prevalence and Co-occurrence of Alcohol, Nicotine, and Other Substance Use Disorder Diagnoses Among US Transgender and Cisgender Adults. JAMA Network Open, 4(2), e2036512. 10.1001/jamanetworkopen.2020.36512 [DOI] [PMC free article] [PubMed] [Google Scholar]
  65. Israel BA, Parker EA, Rowe Z, Salvatore A, Minkler M, López J, Butz A, Mosley A, Coates L, Lambert G, Potito PA, Brenner B, Rivera M, Romero H, Thompson B, Coronado G, & Halstead S (2005). Community-based participatory research: Lessons learned from the Centers for Children’s Environmental Health and Disease Prevention Research. Environmental Health Perspectives, 113(10), 1463–1471. 10.1289/ehp.7675 [DOI] [PMC free article] [PubMed] [Google Scholar]
  66. Israel BA, Schulz AJ, Parker EA, & Becker AB (1998). Review of community-based research: Assessing partnership approaches to improve public health. Annual Review of Public Health, 19, 173–202. 10.1146/annurev.publhealth.19.1.173 [DOI] [PubMed] [Google Scholar]
  67. Jarlenski M, Koma JW, Zank J, Bodnar LM, Bogen DL, & Chang JC (2017). Trends in perception of risk of regular marijuana use among US pregnant and nonpregnant reproductive-aged women. American Journal of Obstetrics and Gynecology, 217(6), 705–707. 10.1016/j.ajog.2017.08.015 [DOI] [PMC free article] [PubMed] [Google Scholar]
  68. Johnstone S, Dela Cruz GA, Kalb N, Tyagi SV, Potenza MN, George TP, & Castle DJ (2023). A systematic review of gender-responsive and integrated substance use disorder treatment programs for women with co-occurring disorders. The American Journal of Drug and Alcohol Abuse, 49(1), 21–42. 10.1080/00952990.2022.2130348. [DOI] [PubMed] [Google Scholar]
  69. Joyce KM, Good KP, Tibbo P, Brown J, & Stewart SH (2021). Addictive behaviors across the menstrual cycle: a systematic review. Archives of Women’s Mental Health, 24(4), 529–542. 10.1007/s00737-020-01094-0 [DOI] [PubMed] [Google Scholar]
  70. Joyce KM, Thompson K, Good KP, Tibbo PG, O’Leary ME, Perrot TS, Hudson A, & Stewart SH (2021). The impact of depressed mood and coping motives on cannabis use quantity across the menstrual cycle in those with and without pre-menstrual dysphoric disorder. Addiction, 116(10), 2746–2758. 10.1111/add.15465 [DOI] [PubMed] [Google Scholar]
  71. Keuroghlian AS, Reisner SL, White JM, & Weiss RD (2015). Substance use and treatment of substance use disorders in a community sample of transgender adults. Drug and Alcohol Dependence, 152, 139–146. 10.1016/j.drugalcdep.2015.04.008 [DOI] [PMC free article] [PubMed] [Google Scholar]
  72. Keyes KM, Grant BF, & Hasin DS (2008). Evidence for a closing gender gap in alcohol use, abuse, and dependence in the United States population. Drug and Alcohol Dependence, 93(1–2), 21–29. 10.1016/j.drugalcdep.2007.08.017. [DOI] [PMC free article] [PubMed] [Google Scholar]
  73. Killeen TK, Greenfield SF, Bride BE, Cohen L, Gordon SM, & Roman PM (2011). Assessment and treatment of co-occurring eating disorders in privately funded addiction treatment programs: Eating disorders and addiction treatment. American Journal of Addiction, 20(3), 205–211. 10.1111/j.1521-0391.2011.00122.x [DOI] [PMC free article] [PubMed] [Google Scholar]
  74. Killeen TK, Wolf B, Greer TL, Carmody T, Rethorst CD, & Trivedi MH (2020). Gender and racial/ethnic differences in physiologic responses in the Stimulant Reduction Intervention using Dosed Exercise Study. Addictive Behaviors, 110, 106546. 10.1016/j.addbeh.2020.106546 [DOI] [PMC free article] [PubMed] [Google Scholar]
  75. Killeen T, Hien D, Campbell ANC, Brown C, Hansen C, Jiang H, Kristman-Valente A, Neuenfeldt C, Rocz de la Luz N, Sampson R, Suarez-Morales L, Wells E, Brigham G, Nunes EV (2008). Adverse events in an integrated trauma-focused intervention for women in community substance abuse treatment. Journal of Substance Abuse Treatment, 35(3), 304–311. 10.1016/j.jsat.2007.12.001 [DOI] [PMC free article] [PubMed] [Google Scholar]
  76. Kitsantas P, & Pursell SR (2024). Are health care providers caring for pregnant and postpartum women ready to confront the perinatal cannabis use challenge? American Journal of Perinatology, 41(S 01), e3249–e3254. 10.1055/s-0043-1777669 [DOI] [PubMed] [Google Scholar]
  77. Kliewer W, Svikis DS, Yousaf N, Ashton H, & Cyrus JW (2022). Psychosocial interventions for alcohol and/or drug misuse and use disorders in women: A systematic review. Journal of Women’s Health, 31(9), 1271–1304. 10.1089/jwh.2021.0488. [DOI] [PubMed] [Google Scholar]
  78. Krist AH, Davidson KW, Mangione CM, Barry MJ, Cabana M, Caughey AB, Curry SJ, Donahue K, Doubeni CA, Epling JW Jr, Kubik M, Ogedegbe G, Pbert L, Silverstein M, Simon MA, Tseng CW, & Wong JB (2020). Screening for unhealthy drug use: US Preventive Services Task Force recommendation statement. JAMA, 323(22), 2301–2309. 10.1001/jama.2020.8020 [DOI] [PubMed] [Google Scholar]
  79. Kropp FB, Smid MC, Lofwall MR, Wachman EM, Martin PR, Murphy SM, Wilder CM, & Winhusen TJ (2023). Collaborative care programs for pregnant and postpartum individuals with opioid use disorder: Organizational characteristics of sites participating in the NIDA CTN0080 MOMs study. Journal of Substance Use & Addiction Treatment, 149, 209030. 10.1016/j.josat.2023.209030 [DOI] [PMC free article] [PubMed] [Google Scholar]
  80. Kulesza M, Larimer ME, & Rao D (2013). Substance use related stigma: What we know and the way forward. Journal of Addictive Behaviors, Therapy & Rehabilitation, 2(2), 782. 10.4172/2324-9005.1000106 [DOI] [PMC free article] [PubMed] [Google Scholar]
  81. LaVeaux D, & Christopher S (2009). Contextualizing CBPR: Key principles of CBPR meet the Indigenous research context. Pimatisiwin, 7(1), 1. [PMC free article] [PubMed] [Google Scholar]
  82. Lee JD, Nunes EV Jr, Novo P, Bachrach K, Bailey GL, Bhatt S, Farkas S, Fishman M, Gauthier P, Hodgkins CC, King J, Lindblad R, Liu D, Matthews AG, May J, Peavy KM, Ross S, Salazar D, Schkolnik P, Shmueli-Blumberg D, … Rotrosen J (2018). Comparative effectiveness of extended-release naltrexone versus buprenorphine-naloxone for opioid relapse prevention (X:BOT): a multicentre, open-label, randomised controlled trial. Lancet, 391(10118), 309–318. 10.1016/S0140-6736(17)32812-X [DOI] [PMC free article] [PubMed] [Google Scholar]
  83. Levine EA, Sugarman DE, Rockas M, McHugh RK, Jordan C, & Greenfield SF (2023). Alcohol treatment access and engagement among women in the USA: A targeted review of the literature 2012–2022. Current Addiction Reports, 10, 638–648. 10.1007/s40429-023-00515-1. [DOI] [PMC free article] [PubMed] [Google Scholar]
  84. Lewis B, Hoffman LA, & Nixon SJ (2014). Sex differences in drug use among polysubstance users. Drug and Alcohol Dependence, 145, 127–133. 10.1016/j.drugalcdep.2014.10.003 [DOI] [PMC free article] [PubMed] [Google Scholar]
  85. Livingston JD, Milne T, Fang ML, & Amari E (2012). The effectiveness of interventions for reducing stigma related to substance use disorders: A systematic review. Addiction, 107(1), 39–50. 10.1111/j.1360-0443.2011.03601.x [DOI] [PMC free article] [PubMed] [Google Scholar]
  86. Lofwall MR, Young JL, Hansen Z, Wachman EM, Wilder C, Guille C, Charles JE, Leeman L, Gray JR, & Winhusen TJ (2023). What to expect with pregnant or postpartum prescribing of extended-release buprenorphine (CAM2038). Journal of Clinical Gynecology & Obstetrics, 12(3), 110–116. 10.14740/jcgo919 [DOI] [PMC free article] [PubMed] [Google Scholar]
  87. Luce KH, & Crowther JH (1999). The reliability of the Eating Disorder Examination–Self-Report Questionnaire version (EDE-Q). International Journal of Eating Disorders, 25(3), 349–351. [DOI] [PubMed] [Google Scholar]
  88. MacGregor B, Allaire C, Bedaiwy MA, Yong PJ, & Bougie O (2023). Disease burden of dysmenorrhea: Impact on life course potential. International Journal of Women’s Health, 15, 499–509. 10.2147/IJWH.S380006. [DOI] [PMC free article] [PubMed] [Google Scholar]
  89. Martino S, Ondersma SJ, Forray A, Olmstead TA, Gilstad-Hayden K, Howell HB, Kershaw T, & Yonkers KA (2018). A randomized controlled trial of screening and brief interventions for substance misuse in reproductive health. American Journal of Obstetrics and Gynecology, 218(3), 322.e1–322.e12. 10.1016/j.ajog.2017.12.005 [DOI] [PMC free article] [PubMed] [Google Scholar]
  90. Matsuzaka S, & Knapp M (2020). Anti-racism and substance use treatment: Addiction does not discriminate, but do we?. Journal of Ethnicity in Substance Abuse, 19(4), 567–593. 10.1080/15332640.2018.1548323 [DOI] [PubMed] [Google Scholar]
  91. McCrady BS, Epstein EE, & Fokas KF (2020). Treatment interventions for women with Alcohol Use Disorder. Alcohol Research: Current Reviews, 40(2), 08. 10.35946/arcr.v40.2.08. [DOI] [PMC free article] [PubMed] [Google Scholar]
  92. McHugh RK, Devito EE, Dodd D, Carroll KM, Potter JS, Greenfield SF, Connery HS, & Weiss RD (2013). Gender differences in a clinical trial for prescription opioid dependence. Journal of Substance Abuse Treatment, 45(1), 38–43. 10.1016/j.jsat.2012.12.007. [DOI] [PMC free article] [PubMed] [Google Scholar]
  93. McHugh RK, Votaw VR, Sugarman DE, & Greenfield SF (2018). Sex and gender differences in substance use disorders. Clinical Psychology Review, 66, 12–23. 10.1016/j.cpr.2017.10.012. [DOI] [PMC free article] [PubMed] [Google Scholar]
  94. McNeely J, Kumar PC, Rieckmann T, Sedlander E, Farkas S, Chollak C, Kannry JL, Vega A, Waite EA, Peccoralo LA, Rosenthal RN, McCarty D, & Rotrosen J (2018). Barriers and facilitators affecting the implementation of substance use screening in primary care clinics: A qualitative study of patients, providers, and staff. Addiction Science & Clinical Practice, 13(1), 8. 10.1186/s13722-018-0110-8 [DOI] [PMC free article] [PubMed] [Google Scholar]
  95. Mereish EH, & Bradford JB (2014). Intersecting identities and substance use problems: Sexual orientation, gender, race, and lifetime substance use problems. Journal of Studies on Alcohol and Drugs, 75(1), 179–188. 10.15288/jsad.2014.75.179. [DOI] [PMC free article] [PubMed] [Google Scholar]
  96. Mereish EH, Fish JN, & Watson RJ (2023). Intersectional Minority Stress and alcohol, tobacco, and cannabis use among sexual and gender minority adolescents of color: Moderating role of family support. LGBT Health, 10(1), 18–25. 10.1089/lgbt.2021.0430. [DOI] [PMC free article] [PubMed] [Google Scholar]
  97. Messina NP, Braithwaite J, Calhoun S, & Kubiak S (2016). Examination of a violence prevention program for female offenders. Violence and Gender, 3(3), 143–149. 10.1089/vio.2015.0048. [DOI] [Google Scholar]
  98. Messina N, & Zwart E (2021). Breaking the silence and healing trauma for incarcerated women: Peer-facilitated delivery of a brief intervention. MOJ Women’s Health, 10(1), 8–16. 10.15406/mojwh.2021.10.00280. [DOI] [Google Scholar]
  99. Meyer IH (2003). Prejudice, social stress, and mental health in lesbian, gay, and bisexual populations: Conceptual issues and research evidence. Psychological bulletin, 129(5), 674–697. 10.1037/0033-2909.129.5.674 [DOI] [PMC free article] [PubMed] [Google Scholar]
  100. Meyer JP, Isaacs K, El-Shahawy O, Burlew AK, & Wechsberg W (2019). Research on women with substance use disorders: Reviewing progress and developing a research and implementation roadmap. Drug and Alcohol Dependence, 197, 158–163. 10.1016/j.drugalcdep.2019.01.017 [DOI] [PMC free article] [PubMed] [Google Scholar]
  101. Meyers SA, Earnshaw VA, D’Ambrosio B, Courchesne N, Werb D, & Smith LR (2021). The intersection of gender and drug use-related stigma: A mixed methods systematic review and synthesis of the literature. Drug and Alcohol Dependence, 223, 108706. 10.1016/j.drugalcdep.2021.108706 [DOI] [PMC free article] [PubMed] [Google Scholar]
  102. Mond JM, Hay PJ, Rodgers B, Owen C, & Beumont PJV (2004). Validity of the Eating Disorder Examination Questionnaire (EDE-Q) in screening for eating disorders in community samples. Behavior Research and Therapy, 42(5), 551–567. 10.1016/S0005-7967(03)00161-X [DOI] [PubMed] [Google Scholar]
  103. Moreland AD, & McRae-Clark A (2018). Parenting outcomes of parenting interventions in integrated substance-use treatment programs: A systematic review. Journal of Substance Abuse Treatment, 89, 52–59. 10.1016/j.jsat.2018.03.005 [DOI] [PMC free article] [PubMed] [Google Scholar]
  104. Morgan-López AA, Killeen TK, Saavedra LM, Hien DA, Fitzpatrick S, Ruglass LM, & Back SE (2020). Crossover between diagnostic and empirical categorizations of full and subthreshold PTSD. Journal of Affective Disorders, 274, 832–840. 10.1016/j.jad.2020.05.031 [DOI] [PMC free article] [PubMed] [Google Scholar]
  105. Moyer VA (2013). Screening and behavioral counseling interventions in primary care to reduce alcohol misuse: U.S. preventive services task force recommendation statement. Annals of Internal Medicine, 159(3), 210–218. 10.7326/0003-4819-159-3-201308060-00652 [DOI] [PubMed] [Google Scholar]
  106. Najavits LM (2002). Seeking Safety: A Treatment Manual for PTSD and Substance Abuse. New York: Guilford. [DOI] [PubMed] [Google Scholar]
  107. National Academies of Sciences, Engineering, and Medicine. (2022). Measuring Sex, Gender Identity, and Sexual Orientation. The National Academies Press. [PubMed] [Google Scholar]
  108. National Drug Abuse Treatment Clinical Trials Network Dissemination Library. Prenatal Action for Taking Healthy Steps (PATHS) Toolkit. CTN Dissemination Library. Retrieved from https://ctnlibrary.org/paths-oud-nida-ctn-di/ [Google Scholar]
  109. National Institute on Drug Abuse. (2015). About the CTN. Retrieved from https://nida.nih.gov/about-nida/organization/cctn/ctn/about-ctn [Google Scholar]
  110. National Institutes of Health. (2001). Inclusion of women and minorities in clinical research. National Institutes of Health. https://grants.nih.gov/policy-and-compliance/policy-topics/inclusion/women-and-minorities [Google Scholar]
  111. National Institutes of Health. (2022). Analyses and reports on the inclusion of women and minorities in clinical research. National Institutes of Health. https://grants.nih.gov/policy-and-compliance/policy-topics/inclusion/women-and-minorities/analyses [Google Scholar]
  112. National LGBTQIA+ Health Education Center: A Program of the Fenway Institute. (2022). Ready, set, go! Guidelines and tips for collecting patient data on sexual orientation and gender identity (SOGI) – 2022 Update. Retrieved from https://www.lgbtqiahealtheducation.org/publication/ready-set-go-a-guide-for-collecting-data-on-sexual-orientation-and-gender-identity-2022-update/ [Google Scholar]
  113. Niv N, & Hser YI (2007). Women-only and mixed-gender drug abuse treatment programs: service needs, utilization, and outcomes. Drug and Alcohol Dependence, 87(2–3), 194–201. 10.1016/j.drugalcdep.2006.08.017. [DOI] [PubMed] [Google Scholar]
  114. Norman SB, Trim R, Haller M, Davis BC, Myers US, Colvonen PJ, Blanes E, Lyons R, Siegel EY, Angkaw AC, Norman GJ, & Myers T (2019). Efficacy of integrated exposure therapy vs integrated coping skills therapy for comorbid posttraumatic stress disorder and alcohol use disorder: A randomized clinical trial. JAMA Psychiatry, 76(8), 791. 10.1001/jamapsychiatry.2019.0638 [DOI] [PMC free article] [PubMed] [Google Scholar]
  115. Office of Public Health and Science, Health and Human Services Department. (2012). Binge Drinking: A Serious, Under-Recognized Problem Among Women and Girls. [Government]. Health and Human Services Department. https://www.govinfo.gov/app/details/GOVPUB-HE20-PURL-gpo63965 [Google Scholar]
  116. Office of Research on Women’s Health. (2021). ORWH historical timeline: Milestones in women’s health research. National Institutes of Health. https://orwh.od.nih.gov/sites/orwh/files/docs/ORWH21_Timeline_508C.pdf [Google Scholar]
  117. Pachankis JE, McConocha EM, Clark KA, Wang K, Behari K, Fetzner BK, Brisbin CD, Scheer JR, & Lehavot K (2020). A transdiagnostic minority stress intervention for gender diverse sexual minority women’s depression, anxiety, and unhealthy alcohol use: A randomized controlled trial. Journal of Consulting and Clinical Psychology, 88(7), 613–630. 10.1037/ccp0000508 [DOI] [PMC free article] [PubMed] [Google Scholar]
  118. Pardo C, Watson B, Pinkhasov O, & Afable A (2024). Social determinants of perinatal mental health. Seminars in Perinatology, 48(6), 151946. 10.1016/j.semperi.2024.151946 [DOI] [PubMed] [Google Scholar]
  119. Paschen-Wolff MM, Kidd JD, & Paine EA (2023). The state of the research on opioid outcomes among lesbian, gay, bisexual, transgender, queer, and other sexuality- and gender-diverse populations: A scoping review. LGBT Health, 10(1), 1–17. 10.1089/lgbt.2022.0036 [DOI] [PMC free article] [PubMed] [Google Scholar]
  120. Paschen-Wolff MM, Tross S, Mindy Nelson C, Hatch MA, Meche D, Ertl MM, Wright L, & Laschober TC (2025). Factors associated with PrEP awareness and use among men who have sex with men who use drugs in the Southern United States. AIDS Care, 37(1), 21–32. 10.1080/09540121.2024.2438923 [DOI] [PubMed] [Google Scholar]
  121. Paschen-Wolff M, Greenfield SF, Kathryn McHugh R, Burlew K, Pavlicova M, Choo TH, Barbosa-Leiker C, Ruglass LM, Mennenga S, Rotrosen J, Nunes EV, & Campbell ANC (2023). Clinical and psychosocial outcomes by sex among individuals prescribed buprenorphine-naloxone (BUP-NX) or extended-release naltrexone (XR-NTX) for opioid use disorder. The American Journal on Addictions, 32(6), 584–592. 10.1111/ajad.13463 [DOI] [PMC free article] [PubMed] [Google Scholar]
  122. Patten CA, Koller KR, Sinicrope PS, Prochaska JJ, Young C, Resnicow K, Decker PA, Hughes CA, Merritt ZT, McConnell CR, Huang M, & Thomas TK (2023). Facebook intervention to connect Alaska Native people with resources and support to quit smoking: CAN Quit pilot randomized controlled trial. Nicotine & Tobacco Research, 25(4), 803–813. 10.1093/ntr/ntac221 [DOI] [PMC free article] [PubMed] [Google Scholar]
  123. Polak K, Haug NA, Dillon P, & Svikis DS (2023). Substance use disorders in women. The Psychiatric Clinics of North America, 46(3), 487–503. 10.1016/j.psc.2023.04.006 [DOI] [PubMed] [Google Scholar]
  124. Qin LL, Hu Z, Kaminga AC, Luo BA, Xu HL, Feng XL, & Liu JH (2020). Association between cigarette smoking and the risk of dysmenorrhea: A meta-analysis of observational studies. PloS One, 15(4), e0231201. 10.1371/journal.pone.0231201 [DOI] [PMC free article] [PubMed] [Google Scholar]
  125. Randall CL, Roberts JS, Del Boca FK, Carroll KM, Connors GJ, & Mattson ME (1999). Telescoping of landmark events associated with drinking: a gender comparison. Journal of Studies on Alcohol, 60(2), 252–260. 10.15288/jsa.1999.60.252 [DOI] [PubMed] [Google Scholar]
  126. Resnicow K, Soler R, Braithwaite RL, Ahluwalia JS & Butler J (2000). Cultural sensitivity in substance use prevention. Journal of Community Psychology, 28, 271–290. . [DOI] [Google Scholar]
  127. Robinson LD, Walter EE, Deane FP, & Larance BK (2023). Comorbid eating disorders among women receiving treatment for substance use disorders: A systematic review and meta-analysis. Addiction Research & Theory, 31(2), 114–126. 10.1080/16066359.2022.2127692 [DOI] [Google Scholar]
  128. Roche AI, Young A, Sabaque C, Kelpin SS, Sinicrope P, Pham C, Marsch LA, Campbell ANC, Venner K, Baker-DeKrey L, Wyatt T, WhiteHawk S, Nord T, Resnicow K, Young C, Brown A, Bart G, & Patten C (2024). Wiidookaage’win: Beta-test of a Facebook group intervention for Native women to support opioid use recovery. Journal of Substance Use & Addictive Treatments, 163, 209396. 10.1016/j.josat.2024.209396. [DOI] [PMC free article] [PubMed] [Google Scholar]
  129. Ruglass LM, Hien DA, Hu MC, Campbell ANC, Caldeira NA, Miele GM, & Chang DF (2015). Racial/ethnic match and treatment outcomes for women with PTSD and substance use disorders receiving community-based treatment. Community Mental Health Journal, 50(7), 811–822. 10.1007/s10597-014-9732-9 [DOI] [PMC free article] [PubMed] [Google Scholar]
  130. Ruglass LM, Morgan-López AA, Saavedra LM, Hien DA, Fitzpatrick S, Killeen TK, Back SE, & Lopez-Castro T (2020). Measurement nonequivalence of the Clinician-Administered PTSD Scale by race/ethnicity: Implications for quantifying posttraumatic stress disorder severity. Psychological Assessment, 32(11), 1015–1027. 10.1037/pas0000943 [DOI] [PMC free article] [PubMed] [Google Scholar]
  131. Ruglass LM, Papini S, Trub L, & Hien DA (2014). Psychometric properties of the Modified Posttraumatic Stress Disorder Symptom Scale among women with posttraumatic stress disorder and substance use disorders receiving outpatient group treatments. Journal of Trauma Stress Disorders and Treatment, 4(01), 1–7. 10.4172/2324-8947.1000139 [DOI] [PMC free article] [PubMed] [Google Scholar]
  132. Saavedra LM, Morgan-López AA, Hien DA, López-Castro T, Ruglass LM, Back SE, Fitzpatrick S, Norman SB, Killeen TK, Ebrahimi CT, Hamblen J, & CAST, the Consortium on Addictions, Stress and Trauma. (2021). Evaluating treatments for posttraumatic stress disorder, alcohol, and other drug use disorders using meta-analysis of individual patient data: Design and methodology of a virtual clinical trial. Contemporary Clinical Trials, 107, 106479. 10.1016/j.cct.2021.106479 [DOI] [PubMed] [Google Scholar]
  133. Schiff DM, Nielsen TC, Hoeppner BB, Terplan M, Hadland SE, Bernson D, Greenfield SF, Bernstein J, Bharel M, Reddy J, Taveras EM, Kelly JF, & Wilens TE (2021). Methadone and buprenorphine discontinuation among postpartum women with opioid use disorder. American Journal of Obstetrics & Gynecology, 225(4), 424.e1–424.e12. 10.1016/j.ajog.2021.04.210 [DOI] [PMC free article] [PubMed] [Google Scholar]
  134. Seedat S, Scott KM, Angermeyer MC, Berglund P, Bromet EJ, Brugha TS, Demyttenaere K, de Girolamo G, Haro JM, Jin R, Karam EG, Kovess-Masfety V, Levinson D, Medina Mora ME, Ono Y, Ormel J, Pennell BE, Posada-Villa J, Sampson NA, Williams D, … Kessler RC (2009). Cross-national associations between gender and mental disorders in the World Health Organization World Mental Health Surveys. Archives of General Psychiatry, 66(7), 785–795. 10.1001/archgenpsychiatry.2009.36 [DOI] [PMC free article] [PubMed] [Google Scholar]
  135. Shanmugam PK (2017). The influence of social factors in drug addiction–a mini review of work by Miller and Carroll. Journal of Alcoholism & Drug Dependence, 5(4), 272. [Google Scholar]
  136. Sinclair J, Abbott J, Proudfoot A, & Armour M (2023). The place of cannabinoids in the treatment of gynecological pain. Drugs, 83(17), 1571–1579. 10.1007/s40265-023-01951-z [DOI] [PMC free article] [PubMed] [Google Scholar]
  137. Skelton KR, Hecht AA, & Benjamin-Neelon SE (2020). Recreational cannabis legalization in the US and maternal use during the preconception, prenatal, and postpartum periods. International Journal of Environmental Research and Public Health, 17(3), 909. 10.3390/ijerph17030909 [DOI] [PMC free article] [PubMed] [Google Scholar]
  138. Skewes MC, & Blume AW (2019). Understanding the link between racial trauma and substance use among American Indians. American Psychologist, 74(1), 88–100. 10.1037/amp0000331 [DOI] [PMC free article] [PubMed] [Google Scholar]
  139. Sood A (2019). SMART with Dr. Sood: The Four-Module Stress Management and Resiliency Training Program. Global Center for Resiliency and Wellbeing. [Google Scholar]
  140. Sorensen JL, & Copeland AL (2000). Drug abuse treatment as an HIV prevention strategy: a review. Drug and Alcohol Dependence, 59(1), 17–31. 10.1016/s0376-8716(99)00104-0. [DOI] [PubMed] [Google Scholar]
  141. Soto C, West AE, Ramos GG, & Unger JB (2022). Substance and behavioral addictions among American Indian and Alaska Native populations. International Journal of Environmental Research and Public Health, 19(5), 2974. 10.3390/ijerph19052974 [DOI] [PMC free article] [PubMed] [Google Scholar]
  142. Spencer MR, Garnett MF, & Miniño AM (2024). Drug overdose deaths in the United States, 2002–2022. NCHS Data Brief, No. 491. National Center for Health Statistics. 10.15620/cdc:135849 [DOI] [Google Scholar]
  143. Substance Abuse and Mental Health Services Administration (SAMHSA). (2018). Results from the 2018 National Survey on Drug Use and Health: Detailed tables. Retrieved from https://www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHDetailedTabs2018R2/NSDUHDetTabsSect5pe2018.htm [Google Scholar]
  144. Substance Abuse and Mental Health Services Administration (SAMHSA). (2019). 2019 National Survey on Drug Use and Health: Women. Retrieved from https://www.samhsa.gov/data/sites/default/files/reports/rpt31102/2019NSDUH-Women/Women%202019%20NSDUH.pdf [Google Scholar]
  145. Substance Abuse and Mental Health Services Administration (SAMHSA). (2023). Lesbian, gay, and bisexual behavioral health: Results from the 2021 and 2022 National Surveys on Drug Use and Health (SAMHSA publication no. pep23-07-01-001). Center For Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Retrieved from https://www.samhsa.gov/data/report/LGB-Behavioral-Health-Report-2021-2022 [Google Scholar]
  146. Substance Abuse and Mental Health Services Administration (SAMHSA). (2024). 2023 NSDUH detailed tables. Retrieved from https://www.samhsa.gov/data/sites/default/files/reports/rpt47100/NSDUHDetailedTabs2023/NSDUHDetailedTabs2023/2023-nsduh-detailed-tables-sect1pe.htm [Google Scholar]
  147. Substance Abuse and Mental Health Services Administration. (2024). Key substance use and mental health indicators in the United States: Results from the 2023 National Survey on Drug Use and Health (HHS Publication No. PEP24-07-021, NSDUH Series H-59). Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. https://www.samhsa.gov/data/report/2023-nsduh-annual-national-report [Google Scholar]
  148. Sugarman DE, Reilly ME, & Greenfield SF (2017). Treatment outcomes for women with substance use disorders: A critical review of the literature (2010–2016). Current Addiction Reports, 4(4), 482–502. 10.1007/s40429-017-0172-9. [DOI] [Google Scholar]
  149. Thompson AE, Anisimowicz Y, Miedema B, Hogg W, Wodchis WP, & Aubrey-Bassler K (2016). The influence of gender and other patient characteristics on health care-seeking behaviour: A QUALICOPC study. BMC Family Practice, 17, 38. 10.1186/s12875-016-0440-0 [DOI] [PMC free article] [PubMed] [Google Scholar]
  150. Towers EB, Williams IL, Qillawala EI, Rissman EF, & Lynch WJ (2023). Sex/gender differences in the time-course for the development of substance use disorder: A focus on the telescoping effect. Pharmacological Reviews, 75(2), 217–249. 10.1124/pharmrev.121.000361 [DOI] [PMC free article] [PubMed] [Google Scholar]
  151. Trinh NTH, Munk-Olsen T, Wray NR, Bergink V, Nordeng HME, Lupattelli A, & Liu X (2023). Timing of antidepressant discontinuation during pregnancy and postpartum psychiatric outcomes in Denmark and Norway. JAMA Psychiatry, 80(5), 441–450. 10.1001/jamapsychiatry.2023.0041 [DOI] [PMC free article] [PubMed] [Google Scholar]
  152. Trivedi MH, Greer TL, Rethorst CD, Carmody T, Grannermann BD, Walker R, Warden D, Shores-Wilson K, Stoutenberg M, Oden N Silverstein M, Hodgkins C, Love L, Seamans C, Stotts A, Causey T, Szucs-Reed RP, Rinaldi P, Myrick H, … Nunes EV (2017). Randomized controlled trial comparing exercise to health education for stimulant use disorder: Results from the CTN-0037 Stimulant Reduction Intervention Using Dosed Exercise (STRIDE) study. The Journal of Clinical Psychiatry, 78(8), 1075–1082. 10.4088/JCP.15m10591 [DOI] [PMC free article] [PubMed] [Google Scholar]
  153. Tross S, Campbell AN, Cohen LR, Calsyn D, Pavlicova M, Miele GM, Hu MC, Haynes L, Nugent N, Gan W, Hatch-Maillette M, Mandler R, McLaughlin P, El-Bassel N, Crits-Christoph P, & Nunes EV (2008). Effectiveness of HIV/STD sexual risk reduction groups for women in substance abuse treatment programs: results of NIDA Clinical Trials Network Trial. Journal of Acquired Immune Deficiency Syndromes, 48(5), 581–589. 10.1097/QAI.0b013e31817efb6e. [DOI] [PMC free article] [PubMed] [Google Scholar]
  154. Trost SL, Beauregard JL, Smoots AN, Ko JY, Haight SC, Moore Simas TA, Byatt N, Madni SA, & Goodman D (2021). Preventing pregnancy-related mental health deaths: Insights from 14 U.S. Maternal Mortality Review Committees, 2008–2017. Health affairs, 40(10), 1551–1559. 10.1377/hlthaff.2021.00615 [DOI] [PMC free article] [PubMed] [Google Scholar]
  155. Udo T, & Grilo CM (2018). Prevalence and correlates of DSM-5-defined eating disorders in a nationally representative sample of U.S. adults. Biological Psychiatry, 84(5), 345–354. 10.1016/j.biopsych.2018.03.014 [DOI] [PMC free article] [PubMed] [Google Scholar]
  156. Valeri L, Sugarman DE, Reilly ME, McHugh RK, Fitzmaurice GM, & Greenfield SF (2018). Group therapy for women with substance use disorders: In-session affiliation predicts women’s substance use treatment outcomes. Journal of Substance Abuse Treatment, 94, 60–68. 10.1016/j.jsat.2018.08.008. [DOI] [PMC free article] [PubMed] [Google Scholar]
  157. Ware OD, Neukrug H, & Goode RW (2024). Mental health facilities with eating disorder treatment programs and substance use disorder treatment in the United States. Eating Disorders, 32(4), 387–400. 10.1080/10640266.2024.2310345 [DOI] [PubMed] [Google Scholar]
  158. Weber A, Miskle B, Lynch A, Arndt S, & Acion L (2021). Substance use in pregnancy: Identifying stigma and improving care. Substance Abuse and Rehabilitation, 12, 105–121. 10.2147/SAR.S319180 [DOI] [PMC free article] [PubMed] [Google Scholar]
  159. Weisbeck SJ, Bright KS, Ginn CS, Smith JM, Hayden KA, & Ringham C (2021). Perceptions about cannabis use during pregnancy: A rapid best-framework qualitative synthesis. Canadian Journal of Public Health, 112(1), 49–59. 10.17269/s41997-020-00346-x [DOI] [PMC free article] [PubMed] [Google Scholar]
  160. White AM (2020). Gender differences in the epidemiology of alcohol use and related harms in the United States. Alcohol Research: Current Reviews, 40(2), 01. 10.35946/arcr.v40.2.01 [DOI] [PMC free article] [PubMed] [Google Scholar]
  161. Wilsnack SC, Klassen AD, & Wilsnack RW (1984). Drinking and reproductive dysfunction among women in a 1981 national survey. Alcoholism, Clinical and Experimental Research, 8(5), 451–458. 10.1111/j.1530-0277.1984.tb05700.x [DOI] [PubMed] [Google Scholar]
  162. Wingood GM, & DiClemente RJ (2008). The ADAPT-ITT model: A novel method of adapting evidence-based HIV Interventions. Journal of Acquired Immune Deficiency Syndromes, 47(S1), S40–S46. 10.1097/QAI.0b013e3181605df1 [DOI] [PubMed] [Google Scholar]
  163. Winhusen TJ, Kropp F, Greenfield SF, Krans EE, Lewis D, Martin PR, Gordon AJ, Davies TH, Wachman EM, Douaihy A, Parker K, Xin X, Jalali A, & Lofwall MR (2025). Trauma prevalence and its association with health-related quality of life in pregnant persons with opioid use disorder. Journal of Addiction Medicine, 19(1), 20–25. 10.1097/ADM.0000000000001366 [DOI] [PMC free article] [PubMed] [Google Scholar]
  164. Young A, Sinicrope P, Kelpin S, Roche AI, Sabaque C, Pham C, Marsch LA, Campbell ANC, Venner K, Bastian E, Nord T, Mason G, Baker L, Wyatt T, Fish A, Bart G, & Patten CA (2024). Wiidookaage’Win: A community-based qualitative approach to developing a Facebook group intervention for Native women to support recovery from opioid use. American Journal of Health Promotion, 38(2), 205–218. 10.1177/08901171231205355 [DOI] [PMC free article] [PubMed] [Google Scholar]

RESOURCES