The Importance of Justice and Health Care Partnerships in MOUD Feasibility Trials

Abstract

This paper overviews the importance of justice and health-care partnerships in a MOUD feasibility trial in a rural Appalachian community. Research partners included a local jail, a local community supervision office, and a local community federally qualified health center. This paper describes the pilot feasibility study participants and methodology, as well as lessons learned including the challenges encountered and needed changes to address feasibility as the environment changes over time. Implications for social work research, practice, and policy advocacy focused on delivery of extended-release naltrexone and other MOUDs are discussed.

Social workers serve on the front lines of the opioid epidemic in various arenas, including health care and criminal justice. The staggering rates of drug overdose deaths continue to rise, particularly in light of COVID-19 restrictions leading to isolation and increased barriers to access to needed services (Centers for Disease Control and Prevention (CDC), 2020; Glick et al., 2020; Patel et al., 2021). Research has well documented the tremendous health and social consequences of the opioid epidemic in rural communities (Palombi et al., 2018). Rural Appalachia has been the epicenter of the opioid epidemic for the last couple of decades. As a region of the country with exceedingly high rates of poverty and limited medical and behavioral health services, it was uniquely vulnerable to the insurgence of prescription opioids that flooded the region in 1990s (Moody et al., 2017). The economic costs associated with the medical and social consequences of opioid use disorder and fatal opioid overdoses were estimated at more than 1 trillion dollars in 2017 (Luo et al., 2021), which has taken a tremendous toll on individuals, families, and communities in the impoverished areas of rural Appalachia (Betz et al., 2020).

Pronounced health disparities in rural Appalachia are often attributed to economic challenges, poverty, and limitations in health-care access (Appalachian Regional Commission, 2021); those health disparities have been exacerbated by the opioid epidemic (Maxwell, 2011), including disproportionate rates of overdose (Akers et al., 2016), injection drug use (Staton-Tindall et al., 2015), and risk for transmission of infectious diseases (Strathdee & Beyrer, 2015). Despite significant risks, rural Appalachians bear greater OUD-related health burdens due to limited access to treatment services because of transportation difficulties, long travel distances to existing services, wait lists, and service costs (Bunting et al., 2018; Oser & Harp, 2015). Rural substance users, including those in Appalachia, often report additional increased barriers to service access, including affordability, availability, acceptability, and stigma compared to urban substance users (Booth et al., 2000). Thus, there is an increased need for coordinated systems of care to reach high-risk, underserved individuals in rural Appalachia.

Despite growing evidence showing medications approved by the Food and Drug Administration (FDA) to treat opioid use disorder (MOUD) decrease risk of death, numerous barriers exist related to MOUD utilization in rural communities (Campbell et al., 2022; Lister et al., 2020), including those in Appalachia. With the increased number of individuals serving time in jails and prisons related to charges associated with opioid misuse, the criminal justice system provides a unique opportunity for implementation of MOUD, yet uptake remains low. Most MOUD protocols in jails and prisons are focused on either pregnant women or individuals who are actively in treatment programs, which is a small percentage of the overall number of individuals who need treatment (Scott et al., 2021; Substance Abuse and Mental Health Service Administration [SAMHSA], 2019). The majority of criminal justice systems lag behind in the promotion of evidence-based medication and behavioral health services for the treatment of MOUD, focusing instead mostly on punishment for the commission of crimes. Punishment has been prejudicial toward individuals who commit substance use-related crimes for the last 50 years since the War on Drugs (Cohen et al., 2022). Shifting the pendulum toward more of a public health addiction treatment model to change criminal behavior has been much more challenging (Volkow, 2021; Volkow et al., 2017). This, however, is critical for social work practice and research in order to better understand addiction as the driver of incarceration, re-incarceration, and overdose deaths at community reentry (Centers for Disease Control and Prevention (CDC), 2020).

The importance of partnerships and interagency collaboration has been touted as critical for success of expanding MOUD treatment in rural communities in particular (Campbell et al., 2022). Despite being uniquely positioned for interagency collaboration across disciplines of public health, public safety, and public welfare, social work is often underutilized, inadequately funded, and overlooked in the opioid-epidemic battle. Social workers are uniquely positioned to advance the implementation of MOUD treatment protocols which, in underserved rural communities, require partnerships between justice-settings (jails), those who monitor justice-involved individuals in the community (probation/parole), and clinical partners (who provide treatment including FDA-approved medications) and, across the partnership, an understanding of local and state policies on MOUD. Successful partnerships require a sense of shared values around treatment – values specific to how treatment should be delivered and who should receive it. This sense of shared values may require a shift away from traditional silos of thinking around whether addiction is a crime and thus needs punishment because laws were broken (possession, theft, property crime) and whether it is true medical illness. Addiction is a public health issue and a public safety issue – calling for critical efforts to bridge the arenas of health care and criminal justice. Within each of these arenas, evidence of misinformation and discrimination against addiction has been shown through violations of the Americans with Disabilities Act (ADA) within justice settings (Sinkman & Dorchak, 2022) and the need for the Wellstone and Domenici Mental Health Parity and Addiction Equality Act to help ensure behavioral and mental health disorders receive equal health insurance coverage similar to other medical illnesses (Centers for Medicare and Medicaid Services, n.d.). Thus, developing partnerships that bridge the gap between justice and health care must be aware of the potential for unconscious biases and stigma that are deeply rooted in those institutions, a challenge for which social work research, practice, and policy is uniquely positioned to respond.

In part, silos exist because of the way our federal and state and local policies are structured for addiction treatment, as well as the ways in which both justice and health-care settings are funded and reimbursed. This paper highlights the critical importance of establishing partnerships that span health and justice silos in order to deliver extended-release naltrexone (XR-NTX), an FDA-approved medication treatment for OUD, among justice-involved individuals with OUD in one rural community. Phase 1 of this study (Staton et al., 2021) included collaborative work with justice and health partners to culturally adapt the state Department of Corrections (DOC) XR-NTX protocol for use in one rural community. Grounded in the ADAPT-ITT framework, the XR-NTX protocol was adapted using focus groups, pilot testing, and expert consultation for delivery in a rural Appalachian community. The model was innovative in that there was no existing coordinated system of care for XR-NTX delivery at the time of study implementation, and Phase 1 provided a critical opportunity for partnership development in tailoring the protocol to be the best fit within the existing system to provide XR-NTX initiation in jail and continue follow-up XR-NTX injections during community supervision.

The current paper describes the components of the Phase 2 pilot trial (e.g., screening, medical evaluation, and initiation) in a small rural Appalachian community, a coordinated effort between the research team, the local jail, the local community supervision (Probation and Parole – P&P) office, and a local community federally qualified health center (FQHC). Lessons learned from this pilot trial are also discussed, including the challenges encountered and needed changes as the environment changes over time.

Materials and methods

Participants

Participants in the pilot feasibility trial were individuals with opioid use disorder, who were involved with the criminal justice system in one rural Appalachian county in Kentucky between September 2018 and March 2022. Referrals came from individuals working in the criminal justice system in the county, including individuals with the Department of Corrections (DOC) and the local Probation and Parole (P&P) office. Weekly check-ins were conducted between the University of Kentucky research staff and contacts at DOC and P&P to determine any new referrals who were currently incarcerated at the local jail and were expected to be released to community supervision with the county P&P office. Following implementation of COVID-19 restrictions, recruitment was expanded to include individuals who were currently on community supervision without the requirement of being incarcerated at the time of referral. University of Kentucky research staff encouraged partners to refer anyone who met these initial criteria, and research staff conducted screening to assess eligibility. Eligibility criteria are described in detail below and was determined at two study phases: (1) screening (meeting criteria consistent with OUD, community supervision in the targeted rural community, and willingness to participate), and (2) medical evaluation (body mass index under 40; liver enzyme values (i.e., AST and ALT) less than five times the upper limit of normal; no physical or mental health conditions that would interfere with study participation and negative pregnancy test and a willingness to use birth control (for female participants).

Measures

Severity of opioid use was assessed using the NIDA-modified version of the Alcohol, Smoking, and Substance Involvement Screening Test (NM-ASSIST; National Institute on Drug Abuse (NIDA), 2009; Staton et al., 2023). Two scales of NM-ASSIST were incorporated into the current study screening, including assessment of prescription opioids and street opioids (e.g., heroin and fentanyl) in the 3 months before incarceration. A substance involvement (SI) score ranging from 0 to 39 was computed based on responses to the frequency of problematic opioid use, with higher scores being indicative of higher degree of drug use severity (scores 4+ used for study eligibility indicate moderate need for intervention).

Severity of opioid use was also assessed using the DSM OUD Checklist (American Psychiatric Association (Eds.), 2013). The screening tool used to assess for DSM-V diagnosis of opioid use disorder was a locally developed checklist containing the 11 symptoms listed in the DSM for this diagnosis (American Psychiatric Association (Eds.), 2013); symptoms were assessed over the last 12 months and 30 days prior to incarceration. Endorsed criteria were summed for the 12-months and the 30-day time frames, separately, and sum of 2+ items in the last 12 months was considered consistent with meeting criteria for OUD.

Other measures of drug use included the Timeline Followback (TLFB; Sobell & Sobell, 1992) method of assessing the frequency of use of opioids and other substances during the last 30 days (including any possible time they were incarcerated). The TLFB was used in part to determine possible withdrawal and/or contraindication of the naltrexone challenge. Individuals who completed the baseline interview were also asked about age of first use of certain substances, route of administration, and years of regular use.

Procedure

Individuals who were referred to the study were contacted by research staff at rural jails prior to COVID-19 restrictions or in the community following restrictions. All sessions, whether at the jail or in the community, were conducted in a private space, and no jail staff were present for any interviews. Prior to consenting, all individuals were asked to complete a brief screen, which included the following: (1) interested in hearing about a study involving XR-NTX administration; (2) if they were incarcerated whether or not they anticipated being released in the next 30 days; (3) if they used opioids in the last year; and (4) if they anticipated being on community supervision in the targeted rural county. Individuals were also asked if they were currently enrolled in insurance coverage or were willing to obtain insurance for ongoing injections in the community. Individuals who reported an anticipated-release date in the next 30 days (if incarcerated), opioid use in the last year, and anticipated community supervision in the targeted rural county were screened for study eligibility by the research team.

Screening

Individuals who completed and passed the brief pre-screen described earlier were provided with informed consent. Consenting participants then completed the NM-ASSIST and DSM OUD Checklist, and the TLFB for all substance use in the last 30 days (including time incarcerated). Participants also completed a brief mental health assessment to determine any thoughts of harming themselves or others or experiencing hallucinations, as well as questions on injection practices, history of difficulty obtaining blood samples in health-care settings, and details about their insurance coverage. Participants’ weight and height were determined by calculating their body mass index (BMI). Participants received HIV/HCV pretest and posttest counseling and rapid HIV and HCV tests. Urine samples were tested using point-of-care tests for 13 substances (e.g., oxycodone, methadone, opiates, and buprenorphine), a separate fentanyl dipstick drug test, and a pregnancy test (for female participants). During COVID-19 restrictions, participants were unable to provide biological samples at the jail, but were able to schedule a time to for optional testing at the local research office. Female participants had to agree to use some form of birth control throughout the study to be eligible.

Following screening, inclusion criteria for being referred for Medical Evaluation included (1) NM-ASSIST score of 4+ for any drug or DSM OUD checklist score of 2+ for past 30 days or year opioid use; (2) currently incarcerated at the targeted local rural jail with an anticipated-release date in the next 30 days (revised during COVID-19 to include individuals not currently incarcerated); (3) anticipated community supervision at the rural county P&P office; and (4) willingness to participate. Participants were paid $25 for completing the screening session. Eligible participants meeting these study screening criteria were then provided with a more detailed main study consent document that reviewed the testing conducted during the medical evaluation, details on XR-NTX administration and study procedures, and potential risks with study participation. After main study informed consent, participants were referred to the study primary care treatment partner (local FQHC) for a medical evaluation session.

Medical evaluation

The local FQHC clinic scheduled staff to go to the local county jail to complete the medical evaluation in a private space prior to COVID-19 restrictions and scheduled the participant to come to the clinic following implementation of COVID-19 restrictions since visitors were no longer allowed at the jail. During the medical evaluation, the participant completed forms to be enrolled as a patient at the clinic; underwent a history and physical (H&P) examination with vital sign collection and BMI calculation; provided a urine sample for drug testing and pregnancy test (females only); and provided a blood sample for a complete blood count and comprehensive metabolic panel with liver function tests. Providers also completed the Clinical Opiate Withdrawal Scale (COWS) with participants to assess for opioid withdrawal symptoms. Blood was sent to a local laboratory for testing, and clinic staff typically obtained the results within 48 hours.

To be medically eligible to initiate XR-NTX, study participants needed to meet the following criteria: (1)BMI under 40; (2) liver enzyme values (i.e., AST and ALT) less than five times the upper limit of normal; (3) no physical or mental health conditions that would interfere with study participation; and (4) negative pregnancy test and a willingness to use birth control (for female participants). All participants were informed that XR-NTX initiation involved an oral naltrexone challenge (i.e., 12.5 mg test dose) and advised to abstain from opioid use. Participants with an opioid-positive urine test were asked about their recent opioid use to help determine when the naltrexone challenge could be scheduled. Eligible participants were scheduled to complete the XR-NTX Initiation session with clinic staff within a week of the medical evaluation.

Baseline study interview

Between the medical evaluation and XR-NTX Initiation, research staff completed a computerized baseline study interview with participants. The baseline study interview was internally developed and assessed substance use history, criminal justice involvement, and demographics (e.g., race, gender, employment) among other items (copy available upon request). The baseline interview was scheduled at the local county jail prior to COVID-19 restrictions or in the community following COVID-19. Baseline interviews were conducted one-on-one in a private location, and participants were paid $25 for completing the interview.

XR-NTX initiation

The FQHC clinic staff completed the XR-NTX Initiation session at the local county jail prior to COVID-19 restrictions or at the clinic after COVID-19 restrictions. At this visit, participants provided a urine sample to verify that there were no opioids present and female participants were not pregnant. A COWS assessment was performed, and scores less than 8 were required prior to administering the 12.5 mg oral naltrexone challenge dose. Participants were observed for 2 hr after oral naltrexone dose for any signs of precipitated withdrawal. Only those with repeat COWS less than 8 proceeded to receive the XR-NTX injection per standard clinical care. During the 2-hr observation period, participants met with a therapist for an intake for counseling and assessment of psychosocial needs/case management assistance, as part of the standard practice by the clinic, and reviewed the H&P for any updates. The clinic then scheduled the next injection and counseling/case management appointment(s) with the participant.

Ongoing injections

Prior to COVID-19, participants who successfully completed XR-NTX initiation were randomized to ongoing community injections (up to three injections) at the P&P office (experimental condition) or at the local FQHC clinic (treatment as usual) using the Research Randomizer (randomizer.org). Research staff informed the participant of the location of their community injections prior to their release from the jail and also left a reminder of their appointment in their belongings. Following COVID-19 restrictions for in-person visits at the jail and the P&P office, random assignment was no longer feasible, and all participants were scheduled to receive ongoing injections at the clinic.

Clinic staff scheduled and conducted ongoing injections at the local FQHC. Study participants could get three community injections through the study, then transition to care with the clinic. Only one community injection occurred at the P&P office in a private room with clinic staff only (i.e., no P&P staff present in order to ensure participant confidentiality) prior to the COVID shutdown of in-person visits at P&P. All other community injections occurred at the clinic. At the beginning of the session, participants provided urine samples for drug testing and pregnancy tests (female participants). Unlike the XR-NTX Initiation session, participants were not required to test negative for opioids in order to continue to receive XR-NTX. When participants tested positive for opioids, clinic staff completed the TLFB to assess for recent opioid use. If a lapse had occurred but the clinician determined that physical dependence on opioids was unlikely, the injection could proceed. If there were concerns about opioid physical dependence, another oral naltrexone challenge with COWS assessment could be conducted before proceeding with the XR-NTX injection (no participants were required to complete an additional naltrexone challenge). Participants were required to score less than 8 on the COWS to continue with the XR-NTX injection. During these community XR-NTX administration visits, participants also met with the therapist for counseling and a clinical case manager.

Study follow-up

Participants completed a follow-up interview with research staff three-months after their baseline interview. The follow-up interview was internally developed and included questions about their participation in the study and thoughts on MOUD, as well as similar questions asked at the study baseline. Tools utilized for tracking and locating participants for the 3-month interview included monitoring criminal justice databases, addresses and phone numbers provided by the participant, and social media (e.g., Facebook). Follow-up interviews were conducted by research staff in the community, and participants were paid $25 for completing the session plus an additional $25 study completion bonus.

Results

Screening

As shown in Figure 1, 69 individuals were referred to the study and completed the initial prescreening questions (interested in the study, anticipated release from jail in 30 days, opioid use in the past year, and planned supervision in the targeted county). Of those, 47 did not meet prescreening criteria (see, Figure 1). The remaining 22 participants were screened for the study by UK research staff, and of those, 21 were recommended to continue with the clinical medical evaluation phase of the study. One participant did not qualify to continue to the medical evaluation session due to current reports of hallucinations (receiving care from a provider).

Figure 1.

Participant flow figure.

On average, participants endorsed 10.5 criteria on the DSM OUD checklist over the last year, and 8.7 criteria over the last 30 days, indicating severe OUD. All participants reported lifetime use of prescription opioids and had an average NM-ASSIST score of 32.1 for misuse of prescription opioids, with 17 individuals reported injecting prescription opioids. Participants scored an average of 21.0 on NM-ASSIST for street opioids, with 12 reported injecting street opioids (only 18 individuals reported lifetime use of street opioids including heroin or fentanyl). Participants also reported use of a range of substances in the last 30 days on TLFB, including street opioids (23%; heroin, fentanyl), non-prescribed buprenorphine (27%), prescription opioids other than buprenorphine (27%; oxycodone, hydrocodone), methamphetamine (50%), benzodiazepines (23%; Xanax, Klonopin), and marijuana (36%).

Urine drug screening and HIV/HCV testing were also conducted at screening (discontinued after COVID-19 restrictions were implemented). Of those who completed a urine drug screen at screening (n = 16), 11 individuals (69%) tested negative for all substances. Common substances individuals tested positive for included amphetamines (19%), methamphetamine (19%), and THC (19%). Among 17 individuals tested for HIV and HCV at screening, all individuals tested negative for HIV and 53% of the individuals tested positive for HCV (n = 9).

Medical evaluation

Among the 21 individuals who were referred for medical evaluation after study screening, 12 were no longer eligible for injection (see, Figure 1).

Baseline study interview

All nine individuals who completed a medical evaluation also completed a baseline interview for the research project. On average, the participants were about 36 years old, white (100%), male (100%), and reported at least a high-school diploma or General Educational Development (GED) (89%). About half (44%) reported working at least part-time before study enrollment and being single/never married (45%). Participants reported high-risk drug use, including drug injection (89%) and nonfatal overdose (67%). About half reported being in some form of SUD treatment (56%), and 44% reported a lifetime history of MOUD use.

XR-NTX initiation and ongoing injections

Of the nine individuals who remained eligible for the study following the medical evaluation, seven participants received the first XR-NTX injection (see Table 1). Of the non-initiators, one participant had repeated positive drug screens and was removed from the study, and the other participant decided prior to the injection that he was no longer interested in continuing. Of the seven participants who initiated XR-NTX, two participants completed all three injections in the community, and five participants did not continue injections.

Table 1.

Summary of all study XR-NTX initiation and continuity of care.

Participant	Eligible after Screening	Eligible after Medical Evaluation	Initial XR-NTX Injection	On-going Community Injections	Notes
X	Yes	Yes	Yes	Yes	Participant completed all study activities.
Z	Yes	Yes	Yes	Yes	Participant completed all study activities.
R	Yes	Yes	Yes	Yes	Voluntarily decided not to receive the second community injection.
A	Yes	Yes	Yes	No	Absconded, did not keep community appointment for on-going injections.
F	Yes	Yes	Yes	No	Experienced health concern before the first community injection, XR-NTX discontinued.
K	Yes	Yes	Yes	No	Voluntarily decided not to receive any community injections.
T	Yes	Yes	Yes	No	Received the initiation injection, relapsed to methamphetamine, decided to discontinue XR-NTX, requested long-term residential treatment.

Follow-up interviews

Participants who completed the baseline session were eligible to complete a follow-up interview 3 months after baseline. Nine (n = 9) participants completed baseline, and all nine participants (100%) completed the follow-up interview. The high follow-up rate can be directly attributed to the rapport established between the research team in the rural study field office and the participants. Table 2 shows two case studies of participants who successfully completed the first XR-NTX injection in jail, followed by all three injections after release.

Table 2.

Successful participant case studies.

Mr. X is a 47-year-old, white man who was unemployed at the time of his arrest, and his highest level of education as a GED. He reported never being married with two children, both over 18 years old. At the time of enrollment, he was incarcerated in a state jail. He had extensive criminal justice involvement over his lifetime with approximately 30 convictions and more that 10 years of his life spent incarcerated. His current incarceration was for drug trafficking and possession. In general, Mr. X reported good health, no regular medications, no mental health issues, no significant history of medical problems, but had had recent pain in the past 30 days and was increasingly worried about this health. Mr. X. had an extensive history of substance use which began with alcohol, marijuana, and cigarettes between the ages of 15 and 16 years old and then progressing to cocaine, opioids, and methamphetamine in his 20s, 30s, and 40s, respectively. Mr. X reported he regularly injected opioids and methamphetamine leading up to his incarceration, and at least one lifetime drug overdose. At the time of study screening, he scored 11/11 on the OUD checklist and 38/39 on the NM-ASSIST prescription opioids scale. He was eligible to receive the XR-NTX injection after medical evaluation in jail, and he reported that his reason for considering the medication was that he was ‘ready for a change.’

After jail release, Mr. X attended the first scheduled visit for the community injection where he stated that he was non-compliant and had relapsed to methamphetamine use, leading to a positive drug screen, violating his probation and resulting in another brief incarceration. He reported no opioid use since his last injection and stated that he was satisfied with the medication treatment thus far. The participant stated that he was feeling good overall but that he sometimes felt depressed when he thought of his past substance use. Since his release, the participant reported living with his mother while fixing up a trailer near his mother’s house so that he could live in it in the future. He stated that his family, specifically his mother, had been a good social support for him since his release. The participant received his second and then third community injections approximately four weeks after the previous injections. He reported that he was compliant with the XR-NTX treatment at both appointments and not experiencing any side effects from the treatment. The participant reported that his family had been checking on him daily to help encourage him to stop his substance use. He stated that his girlfriend also currently had a substance use disorder, and that she was seeking treatment for it as well. At his third injection appointment, he stated that his girlfriend was sent back to jail, but that she continued to seek treatment for her substance use disorder. He also reported that he was attempting to mend his relationship with one of his children, as he had recently become a grandfather. The participant reported that he was thankful for the XR-NTX program and that he hoped to continue treatment after completion of the study. He stated that this was the longest he had ever been ‘clean.’

Participant Z

Mr. Z is a 34-year-old white man who reported being unemployed at the time of his arrest, and his highest level of education as a GED. He is the father of one child and not married to the child’s mother. At the time of enrollment, he was incarcerated in a state jail. He reported three lifetime convictions and has spent approximately five years total incarcerated. He stated that he would be on probation after his release from his current incarceration. He reported no significant health problems other than insomnia. He reported a significant trauma history, which included the murder of his mother. He describes this event as likely contributing to his substance use. Mr. Z started using cigarettes at the age of 9 and progressed to alcohol and marijuana by age 13. He then began using methamphetamine at 15 years old, and later began using methadone, oxycodone, and buprenorphine in his late 20s and early 30s. He stated that his drugs of choice were methamphetamine and suboxone prior to his current incarceration, and while he used suboxone in the past as treatment, he became addicted to it. He also reported that he had injected methamphetamine, oxycodone, and suboxone. He denied ever experiencing an overdose. At the time of study screening, he scored 10/11 on the OUD checklist and 39/39 on the NM-ASSIST prescription opioids scale. He was eligible to receive the XR-NTX injection after medical evaluation in jail, and he reported that his girlfriend was his primary support, as she previously had a substance use disorder but had been sober for several years. He also stated that his reason for beginning the study is that he is ready to be sober. He successfully received his first XR-NTX injection approximately two weeks before his release.

After jail release, Mr. Z received each of his community injections approximately four weeks apart. He reported that he had been compliant with the study and had not experienced any side effects at every clinic visit. He consistently stated that he was very satisfied with the treatment and called the study a ‘good thing.’ At his last community injection, Mr. Z stated that he was very satisfied with the medication treatment and that he wanted to continue XR-NTX? treatment after completing the study. He continued to attend therapy appointments in which he stated that he had moved in with his girlfriend after his release. He reported that he had been helping her around the house to stay busy and that he was not associating with people from his past in order to help with maintaining his sobriety. Mr. Z stated that he was looking for a job but also reported that he did not have transportation. He successfully completed the study with intention to continue treatment.

Discussion and lessons learned

The overall aim of this NIH/NIDA funded R34 was to examine the feasibility of an innovative service delivery model to increase adherence to extended-release naltrexone (XR-NTX) for rural individuals with opioid use disorder (OUD). Successful development of the XR-NTX initiation protocol and implementation of this feasibility trial was possible because of the strong partnership between the research team, the local jail, the local P&P office, and the local FQHC clinic. The study was implemented based on the Phase 1 clinical protocol (Staton et al., 2021), 22 people were screened, 9 people were enrolled, and 7 people received the first XR-NTX injection. This study shed light on a number of challenges related to the implementation of MOUD protocols in non-traditional, non-treatment rural criminal justice settings. The following section overviews lessons learned from this feasibility pilot trial which may inform social work research and practice on the development of other MOUD studies focused on justice-involved individuals in small rural communities.

Establishing a strong partnership between the DOC, the local P&P office, the local jail, and the community treatment provider (local FQHC clinic) was an essential component of this study. Each stakeholder had their own day-to-day responsibilities (e.g., clinic to operate and staff with full patient loads). Ensuring that there was commitment on the front end to participate in the study, and involvement from each stakeholder in each phase of the process, was necessary. In addition, the processes had to be flexible and easily adapted based on changing environments. For example, research staff had to work closely with P&P staff to identify individuals entering community supervision through various outlets such as prisons, jails, and courts. Future trials should consider having dedicated research staff who assist with planning and scheduling with key stakeholders for consistency, as well as standardized operating procedures that track and document any protocol changes over time.

Each partner brought a number of strengths to the study, and each partner agreed to accept the nuances of doing what they normally do a little differently. For example, our clinic partner already had a naltrexone protocol at their practice. They did not, however, have the same degree of necessary documentation needed for a clinical research trial. This reinforced need for research staff to regularly review all medical documentation and allowed for continued learning for both research and clinic staff. Alternatively, the jail did not have an existing OUD treatment program, but they housed a number of individuals with OUD. By allowing clinic staff to come on site, assess for OUD, and medically evaluate individuals for MOUD treatment was a tremendous change for them (and for the clinical staff who did not regularly work in jails). This feasibility trial provided the ideal opportunity for these partners to work together in different ways to initiate MOUD treatment.

One of the major unanticipated challenges was the limited number of individuals incarcerated in the local rural jail and transitioning to community supervision in the county. Even prior to COVID-19 restrictions, a major change to the study protocol was to expand recruitment to include both men and women in order to increase enrollment (the study was designed for women). While there are a number of individuals incarcerated with a history of opioid use disorder, additional requirements of release time within a certain time frame for XR-NTX initiation and transitioning to supervision in the local P&P office added additional limitations – not to mention also being interested in initiating MOUD, specifically XR-NTX. Thus, for future trials, being able to anticipate each of these factors in projected enrollment is critically important.

Individuals recruited for this study were not in a formal treatment program and were not self-identified as treatment seeking. Recruiting individuals from jail or supervision settings who were abstinent from drugs (many for the first time in many years) and convincing them to consider a medication treatment proved to be challenging. A number of participants dropped out of the study between screening and injection due to positive drug screens, second thoughts about ‘quitting’ and seeking treatment, and absconding from P&P. Future trials may want to consider adding treatment motivation as a screening tool or recruiting from environments where individuals are already engaged in some form of formal treatment.

In spite of these challenges, COVID-19 posed the most significant threat to completion of the randomized pilot trial as originally planned. In March 2020, visitation at all Kentucky jails and community supervision offices was suspended. Even as restrictions started to lift in the winter of 2021, visitation remained suspended at the local jail which made recruitment, medical evaluations, and initial injections impossible. P&P shifted to remote supervision, with some office reporting in the spring of 2021, which made some additional contact with individuals somewhat feasible. However, because the office remained closed to outside visitors, staff from the clinic were no longer able to visit – which ultimately necessitated a change in study design by removing the random assignment to intervention conditions. In light of COVID-19, a number of adaptations and changes were made to the study protocol.

While we do recognize the challenges that have resulted in a traditional feasibility and acceptability assessment not being possible, this study was innovative in the establishment of a partnership between a research team, a local jail, a community supervision office, and a local clinic to pilot test an novel model of MOUD utilization. Future research should be grounded in the basic assumption that opioid use disorder is a complex, medical illness with psychosocial influences – much like type II diabetes and other chronic illnesses. One of the biggest challenges for use of medication to treat OUD is timing. Most justice systems who implement XR-NTX protocols plan for the injection prior to release from jail, which is clearly different than other medications to treat other complex health issues. One of the challenges for XR-NTX (and likely other MOUDs) is that individuals have experienced a period of abstinence during incarceration and perceive there to be little need to initiate prior to leaving jail. This calls for policy changes at both the state and local level to allow medications to be initiated (or even more importantly, continued) during the entire length of stay at a correctional facility. Along these lines, it is also critical that social workers and other health-care providers advocate for the use of all MOUDs (including buprenorphine and methadone) as needed for individually tailored treatment strategies, which may require education and training to reduce stigma within justice settings.

Despite these challenges, this study responded to a NIH high-priority area to increase access to evidence-based treatment due to the increasing rates of OUD and related high-risk injection drug practices among individuals in rural Appalachia (Staton-Tindall et al., 2015). Social workers can play a critical role in battling the opioid epidemic through increased advocacy for MOUDs in a variety of real-world settings where individuals with OUD may be found, as well as increasing access to evidence-based psychosocial services and wraparound services needed for successful MOUD treatment (Lister & Joudrey, 2022). Future research is significantly needed to better understand factors associated with increasing MOUD utilization, particularly in rural areas where services are desperately needed. The study findings also point to the urgent need for states to consider health-care policies that increase access to all FDA medications among justice-involved individuals in rural and urban areas, as well as supporting utilization along a continuum of care from facility entry, facility release, and community reentry.

Data availability statement

Data can be made available upon reasonable request from the corresponding author.