In most substance use disorders, adding behavioral therapy to medical management yields improvement in outcomes. Unexpectedly, this has not been observed when adding behavioral therapy to buprenorphine plus medical management for opioid use disorder (OUD).
R. Kathryn McHugh, PhD, chief of Psychology at McLean Hospital and director of the Stress, Anxiety, and Substance Use Laboratory, and colleagues are planning a study that will systematically examine the efficacy of behavioral therapy for enhancing buprenorphine retention or improving functional outcomes in OUD.
They recently introduced the protocol in Drug and Alcohol Dependence Reports.
Overview
The study will harmonize data from four completed randomized controlled trials funded by the National Institute on Drug Abuse (NIDA): three independent trials, and one NIDA Clinical Trials Network multicenter trial. These collectively included more than 860 participants recruited from sites across the U.S.
All trials compared the triple combination of behavioral therapy, buprenorphine maintenance, and standard structured medical management with buprenorphine plus standard medical management alone for OUD.
Clinical Questions and Outcome Measures
The researchers hope the study will provide answers to pressing clinical questions.
- Who benefits from the addition of behavioral therapy to buprenorphine maintenance? The primary outcome measure will be the number of weeks of opioid use over 12 weeks of treatment
- Does behavioral therapy improve retention in buprenorphine treatment? Retention, too, is often conceptualized as a binary variable (yes/no based on participation in a predetermined number of sessions or in the final session). In contrast, to allow a better understanding of the variability in retention, this study will measure the number of weeks of treatment received.
- Is buprenorphine maintenance plus behavioral therapy more efficacious for functional outcomes than buprenorphine with medical management alone? Functioning will be assessed with the Addiction Severity Index (ASI).
Moderators of Treatment Outcomes
Analyses will also consider whether different subgroups respond differently to behavioral therapy, including the following variables: age, sex, lifetime history of heroin use, cocaine use at baseline/treatment entry, number of prior treatment episodes, presence of chronic pain, presence of co-occurring psychiatric disorders, and level of baseline functional impairment on each of the seven domains of the ASI.
This list is based on previous research and will be complemented with secondary analyses.
Laying the Groundwork for Optimized Behavioral Therapy
OUD is highly heterogeneous, but preliminary research at McLean, published in Drug and Alcohol Dependence, suggests certain subgroups of people with OUD may benefit from adding behavioral therapy to buprenorphine maintenance.
The data gained from this study should help guide shared decision-making and personalization of treatment in OUD. Ultimately, it may also help inform guidelines for buprenorphine prescribing.
Looking for mental health care for someone struggling with addiction to drugs or alcohol? Call us today at 877.322.2749 to refer a patient.
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