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. Author manuscript; available in PMC: 2022 Nov 1.
Published in final edited form as: Drug Alcohol Depend. 2021 Sep 20;228:109084. doi: 10.1016/j.drugalcdep.2021.109084

Do People with Opioid Use Disorder and Posttraumatic Stress Disorder Benefit from Adding Individual Opioid Drug Counseling to Buprenorphine?

R Kathryn McHugh 1,2, Blake T Hilton 1,2, Alexandra M Chase 1, Margaret L Griffin 1,2, Roger D Weiss 1,2
PMCID: PMC8595708  NIHMSID: NIHMS1742560  PMID: 34607194

Abstract

Background and Purpose:

Large randomized trials have found that behavioral therapy for opioid use disorder (e.g., Individual Drug Counseling, Cognitive Behavioral Therapy for Opioid Use Disorder) does not improve buprenorphine maintenance outcomes, on average, for individuals with opioid use disorder. However, recent studies indicate that certain subgroups of patients may benefit from the addition of behavioral therapy to buprenorphine. In particular, people with more complex and severe psychosocial needs may benefit from the addition of behavioral therapy for opioid use disorder.

Methods:

In this study, we conducted a secondary analysis of a large, multi-site randomized trial (N=357) of buprenorphine maintenance with and without individual Opioid Drug Counseling (ODC) for the treatment of opioid use disorder. We hypothesized that participants with posttraumatic stress disorder (PTSD) would benefit from the addition of ODC.

Results:

Logistic regression models indicated a significant PTSD by treatment condition interaction. Specifically, 67% of those with PTSD had a successful opioid use disorder treatment outcome when they were assigned to receive both ODC and buprenorphine, compared to a 36% response rate among those who received buprenorphine alone.

Conclusions:

Although these results require replication, our findings provide initial indication that ODC is an important complement to buprenorphine maintenance treatment for people with co-occurring PTSD and opioid use disorder.

Keywords: opioid use disorder, buprenorphine, posttraumatic stress disorder, behavioral therapy, co-occurring disorders

1. Introduction

Results from large randomized trials have indicated that, on average, people with opioid use disorder (OUD) do not experience better outcomes when Individual Opioid Counseling or Cognitive Behavioral Therapy (CBT) for OUD are added to buprenorphine and medical management (Fiellin et al., 2006; Weiss et al., 2011)1. However, certain subgroups of patients may benefit from the addition of behavioral therapy (Moore et al., 2016; Weiss et al., 2014). For example, two studies have found that the primary type of opioid used (opioid analgesics or heroin) moderates treatment response, although the direction of this effect is unclear (Moore et al., 2016; Weiss et al., 2014). Buprenorphine is an effective treatment and thus may be sufficient for some people with OUD (particularly in the context of the intensive medical management that is characteristic of clinical trials), whereas people who have more complex psychosocial and functional needs may benefit from the addition of behavioral therapy for OUD, which typically addresses both substance use and other psychosocial issues (e.g., interpersonal relationships, coping skills), with a goal of enhancing overall functioning (Carroll and Weiss, 2017).

Exposure to traumatic events and the development of posttraumatic stress disorder (PTSD) are highly prevalent among those with OUD. Over 90% of people with OUD report experiencing a traumatic event in their lifetime, and more than 40% meet criteria for a lifetime diagnosis of PTSD (Mills et al., 2005a). This comorbidity is particularly significant because people with both disorders tend to experience greater severity of OUD (Hassan et al., 2017) and poorer treatment outcomes relative to those with OUD alone (Mills et al., 2005b). Accordingly, individuals with co-occurring PTSD and OUD may benefit from adding behavioral therapy for OUD to buprenorphine.

The aim of this secondary analysis was to evaluate whether PTSD moderates the effect of a behavioral therapy—Opioid Drug Counseling (Pantalon et al., 1999)—on OUD outcomes in adults receiving buprenorphine maintenance. We hypothesized that adults with PTSD seeking treatment for OUD would have better opioid use outcomes if they received individual Opioid Drug Counseling in addition to buprenorphine and medical management, when compared to buprenorphine plus medical management alone. To test this hypothesis, we conducted a secondary analysis of the Prescription Opioid Addiction Treatment Study, a large multi-site randomized clinical trial of buprenorphine maintenance with and without individual Opioid Drug Counseling (Weiss et al., 2011).

2. Material and methods

This is a secondary analysis of the Prescription Opioid Addiction Treatment Study (POATS), a 10-site clinical trial funded by the National Drug Abuse Treatment Clinical Trials Network (Weiss et al., 2011). POATS utilized a two-phase adaptive research design, the methods of which are described in detail elsewhere (Weiss et al., 2010). Briefly, Phase 1 consisted of a 4-week buprenorphine taper with an 8-week follow-up. Participants who did not experience successful outcomes (i.e., abstinence or near abstinence from opioids) were then eligible for Phase 2. Only 7% of participants successfully completed Phase 1; thus, most participants were eligible for Phase 2 (Weiss et al., 2011). This secondary analysis focused on Phase 2 of the POATS trial. In this phase, participants were randomized to receive 12 weeks of buprenorphine along with either standard medical management (Fiellin et al., 1999) or standard medical management plus Opioid Drug Counseling (ODC), a structured behavioral therapy (Pantalon et al., 1999). Both standard medical management and ODC were administered in an individual format.

Standard medical management consisted of brief (15–20 minute) weekly visits with a licensed physician focused on monitoring medication adherence/response, toxicology results, and adverse events. Providers also encouraged lifestyle changes to facilitate recovery (e.g., reducing contact with those who use substances, increased involvement in substance-free activities), abstinence, and attendance at mutual-help groups. Participants in the enhanced medical management arm received standard medical management plus additional 45-minute ODC sessions delivered by a separate licensed substance use or mental health professional; these occurred twice per week for the first six weeks and weekly thereafter (Weiss et al., 2010). During the ODC sessions, clinicians encouraged treatment attendance, medication adherence, mutual-help involvement, and abstinence from opioids; psychoeducational material was also presented and discussed regarding the processes of addiction and recovery, developing a support system, and managing interpersonal relationships and high-risk situations (Weiss et al., 2010). Sessions focused on additional topics relevant to relapse prevention, and covered topics in greater detail than did medical management sessions. Interactive exercises and take-home assignments were used to reinforce skills (Weiss et al., 2011).

2.1. Participants

Adults age 18 and older who met Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (American Psychiatric Association, 2000) criteria for prescription opioid dependence were recruited from people initiating treatment at 10 substance use disorder treatment facilities across the United States. A full description of eligibility criteria is available in prior reports (Weiss et al., 2010). Briefly, exclusion criteria included lifetime diagnosis of OUD attributable to heroin alone, use of heroin on 5 or more of the past 30 days, any history of injection heroin use, ongoing opioid therapy for the treatment of pain, involvement in formal substance use disorder treatment (other than mutual-help groups), and recent receipt of methadone or buprenorphine maintenance treatment. Participants were not restricted from receiving concomitant mental health care; however, this was uncommon (only 4 participants with PTSD reported receiving mental health care during the trial).

2.2. Measures

The Composite International Diagnostic Interview ((World Health Organization, 1997) is a structured, interviewer-administered measure of substance use and psychiatric disorders and was used to determine lifetime PTSD diagnosis. Several measures were also used as indicators of symptom severity and functional impairment in this study. The Beck Depression Inventory II is a 21-item self-report measure of depressive symptoms used to determine symptom severity over the previous two weeks (Beck et al., 1996). Scores range from 0 to 63 with higher scores reflecting more severe depressive symptoms. The Opioid Craving Scale (McHugh et al., 2014) is an adaptation of the Cocaine Craving Scale (Weiss et al., 1995). This 3-item self-report measure has a score range of 0–10, with higher scores indicating more severe craving. The Addiction Severity Index (ASI) is an interviewer-administered measure designed to assess functional impairment and substance use severity (McLellan et al., 1992). Composite scores are calculated across several domains and reflect level of impairment in that domain (e.g., level of self-reported distress in the domain, familial conflict) with values ranging from 0–1; higher values represent greater impairment.

Opioid use was defined as either a self-report of opioid use or a urine drug screen positive for opioids. Consistent with the primary outcome trial, a missing urine was coded as positive. Urine drug screens were conducted weekly and self-report of days of opioid use were collected using the Timeline Follow-Back method (Sobell and Sobell, 1992).

2.3. Data Analysis

We first compared participants with and without PTSD on functional and symptom severity measures using t-tests; nonparametric tests were used for the ASI composite scores due to evidence of skew. For this analysis, we used a binary definition of treatment success, consistent with the primary outcome from the parent trial (Weiss et al., 2011). Successful outcome was defined as abstinence from opioids in the final week of buprenorphine maintenance treatment and abstinence in at least 2 of the 3 prior weeks. We conducted a logistic regression with successful outcome as the dependent variable. The predictor of interest was the PTSD by treatment condition interaction; the model also controlled for the effects of age, gender, study site, and history of heroin use. All analyses were conducted in SPSS Version 20.

3. Results

Of the 360 participants in Phase 2, 357 had PTSD diagnosis data available. Of these, 18.5% (n = 66) had a lifetime diagnosis of PTSD; 39 of these 66 (59.1%) were randomized to ODC. Those with PTSD had higher levels of depressive symptoms (t[355] = −3.48, p < .01), greater opioid craving (t[355] = −3.30, p < .01), and greater impairment in employment, medical, family and psychiatric domains. The only indicators of severity that were not worse in those with PTSD were alcohol- and drug-related impairment and legal impairment (Table 1). A logistic regression model indicated a significant interaction between PTSD and treatment condition (OR = 4.43, 95% CI = 1.37, 14.33, p <.05; Table 2), meaning that the association between treatment condition and outcome differed based on PTSD diagnosis. To further characterize this difference, we conducted separate logistic regressions for participants with and without PTSD, including all covariates as described above. Among those without PTSD, outcomes are similar for those who did and did not receive ODC (OR = 0.997, 95% CI = 0.62, 1.60, p = .99). However, for participants with PTSD, ODC was associated with significantly better outcomes than buprenorphine and medical management alone (OR = 5.27, 95% CI = 1.61, 17.25, p < .01).

Table 1.

Sample Characteristics by Posttraumatic Stress Disorder Diagnosis

PTSD (n=66) No PTSD (n=291) t/χ2 p
Age, mean years (SD) 32.7 (8.0) 32.5 (10.0) −0.22 0.83
Female (%) 66.7% 36.4% 20.19 <.001
Ever used heroin (%) 27.3% 26.1% 0.04 0.85
White (%) 90.9% 90.4% 0.8 0.37
Employed full-time (%) 57.6% 60.8% 0.24 0.63
Beck Depression Inventory, mean (SD) 27.7 (12.1) 22.1 (11.8) −3.48 <.01
Opioid Craving Scale, mean (SD) 8.8 (2.0) 7.8 (2.2) −3.30 <.01
ASI Functional Composite Scores, mean (SD)
 Employment .46 (.30) .36 (.29) * <.05
 Alcohol .05 (.09) .05 (.09) * 0.44
 Drug .35 (.07) .33 (.07) * 0.09
 Psychiatric .24 (.23) .14 (.18) * <.001
 Legal .05 (.12) .05 (.13) * 0.97
 Medical .30 (.36) .19 (.30) * <.05
 Family .23 (.25) .14 (.20) * <.05
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Note: Test statistics (column labeled t/χ2) reflect t-tests for continuous variables and χ2 tests for categorical variables. ASI = Addiction Severity Index

*

= non-parametric test

Table 2.

Logistic Regression Model Predicting Successful Clinical Outcomes

Odds Ratio 95% CI Lower, Upper p
Age 1.03 1.01, 1.05 <.05
Sex (reference = female) 0.78 0.50, 1.22 .28
Study Site .999 .999, 1.00 .99
Heroin Use (reference = no use) 0.55 0.34,0.91 <.05
PTSD (reference = no PTSD) 0.48 0.22,1.04 .06
Treatment (reference = Opioid Drug Counseling) 0.997 0.62, 1.60 .99
PTSD by treatment interaction 4.43 1.37, 4.33 <.05
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Note. Age and the PTSD by treatment interaction do not have reference values because they are continuous variables.

The interaction between PTSD status and treatment condition is shown in Figure 1, unadjusted for covariates. Among people with PTSD, 36% of participants who received buprenorphine alone had a successful outcome, compared to 67% of those who received ODC in addition to buprenorphine.

Figure 1.

Figure 1.

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Successful Outcome by Posttraumatic Stress Disorder Diagnosis and Treatment Condition

4. Discussion

Although evidence suggests that, overall, adults with OUD do not benefit from the addition of Individual Drug Counseling or Cognitive-Behavioral Therapy for OUD to buprenorphine and medical management (Fiellin et al., 2006; Weiss et al., 2011), this study contributes to a growing evidence base suggesting that certain subgroups of patients may benefit from behavioral therapy targeted at OUD (Moore et al., 2016; Weiss et al., 2014). In this secondary analysis of the Prescription Opioid Addiction Treatment Study, PTSD moderated the effect of behavioral therapy on outcome. Only 36% people with PTSD achieved a successful opioid use outcome when receiving buprenorphine and medical management alone, compared to 67% of those who also received ODC. In contrast, among people without PTSD, approximately 50% of people in both arms had a successful outcome.

In this study, the behavioral therapy was a substance use disorder-focused treatment (ODC). This is distinguished from behavioral treatments that target PTSD or PTSD and substance use disorders concurrently (Hien et al., 2010; Moore et al., 2016). Behavioral treatments designed to target PTSD and substance use disorders simultaneously (e.g., treatments that integrate evidence-based exposure therapy for PTSD with Cognitive-Behavioral Therapy for substance use disorders) have shown significant promise for the improvement of both PTSD and substance use outcomes (Mills et al., 2012). Testing these treatments added to buprenorphine will be an important future direction for improved treatment response for both OUD and PTSD symptoms in this population.

The reasons for this difference in treatment response are unknown. It is of note that those with PTSD exhibited poorer functioning and greater psychiatric severity, consistent with the literature (Hassan et al., 2017). This group may benefit from the addition of ODC, which can also directly address recovery of functioning and engagement of coping skills and social support. Although buprenorphine may help to support abstinence from illicit opioids, without attention to engaging additional skills to support psychosocial needs, this population may not respond adequately. It is also possible that the additional time with a provider in the ODC condition or overlap between this treatment and evidence-based PTSD treatments afforded greater benefit for this group. What is less clear is why these additional skills and time allocation offered no measurable additive benefit for people without PTSD, although one possibility is that the robust standard medical management condition and the strong efficacy of buprenorphine may have been sufficient for a larger portion of the OUD-only group.

Further research on the role of behavioral therapy in OUD is an important future research direction. If indeed there are subgroup differences in response to behavioral therapy when added to buprenorphine, greater understanding of mechanisms underlying this effect is needed to improve outcomes both in this subgroup as well as the groups of patients who do not respond to buprenorphine, either with or without behavioral therapy. Better understanding of the effects of treatment adherence (effects of behavioral therapies on medication adherence and the effects of behavioral therapy adherence on overall outcomes) will be important to better parse these subgroup effects.

This study has several limitations. First, this is a secondary data analysis not designed to detect such moderation effects. Second, the study did not collect data on PTSD symptom outcomes and thus it is unclear whether PTSD improved during the treatment in either group. Understanding the trajectory of PTSD symptoms in this population, including whether they require adjunctive PTSD-targeted intervention, is an important direction for future research on OUD treatment. Furthermore, PTSD diagnoses were lifetime; current PTSD status was not assessed. It is also notable that the prevalence of PTSD in our sample was lower than estimates typically reported in the literature (Mills et al., 2005a), although the reason for this is not known. Finally, this study was limited to participants who were predominantly misusing opioid analgesics, with minimal to no heroin use, which may reflect a less severe population than one unselected for primary opioid type. Whether these findings would generalize to people predominantly misusing heroin or fentanyl/fentanyl analogues is unknown.

5. Conclusion

This study provides further evidence that behavioral therapy for OUD may play an important role in treatment for certain people with OUD. This is consistent with studies of methadone maintenance, in which the addition of counseling improved outcomes, particularly among vulnerable patients (McLellan et al., 1993; Woody et al., 1984). Understanding factors associated with treatment response is essential for informing personalized treatments for people with OUD (Blanco et al., 2020; Volkow, 2020). These results require replication; however, they indicate that for people with PTSD, ODC may be beneficial for those receiving buprenorphine maintenance. Further research is needed to identify other subgroups and vulnerability factors that indicate benefit from adding behavioral therapy for OUD to buprenorphine maintenance.

Highlights.

  • PTSD is common in people with opioid use disorder

  • Those with PTSD have worse functioning than opioid use disorder alone

  • PTSD moderated the response to drug counseling added to buprenorphine

  • Drug counseling was associated with improved outcome only in people with PTSD

Role of Funding Source

Effort for this project was supported by NIDA grants DA015831 and DA046937, and the Charles Engelhard Foundation.

Footnotes

Conflict of Interest

In the past 12 months, Dr. Weiss has consulted to Analgesic Solutions. All other authors have no disclosures or potential conflicts of interest to report.

1

For a review and critique of this literature, including discussion of the efficacy of contingency management tin this population, see Carroll and Weiss, 2017

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