Study design to evaluate a group-based therapy for support persons of adults on buprenorphine/naloxone

Abstract

Abstract Background Opioid use disorders (OUDs) have devastating effects on individuals, families, and communities. While medication treatments for OUD save lives and are increasingly utilized, rates of treatment dropout are very high. In addition, most existing medication treatments for OUD may often neglect the impact of untreated OUD on relationships and ignore the potential role support persons (SPs) could have on encouraging long-term recovery, which can also impact patient treatment retention. Methods/design The current study adapts Community Reinforcement and Family Training (CRAFT) for use with SPs (family member, spouse or friend) of patients using buprenorphine/naloxone (buprenorphine) in an outpatient community clinic setting. The study will evaluate whether the adapted intervention, also known as integrating support persons into recovery (INSPIRE), is effective in increasing patient retention on buprenorphine when compared to usual care. We will utilize a two-group randomized design where patients starting or restarting buprenorphine will be screened for support person status and recruited with their support person if eligible. Support persons will be randomly assigned to the INSPIRE intervention, which will consist of 10 rolling group sessions led by two facilitators. Patients and SPs will each be assessed at baseline, 3 months post-baseline, and 12 months post-baseline. Patient electronic medical record data will be collected at six and 12 months post-baseline. We will examine mechanisms of intervention effectiveness and also conduct pre/post-implementation surveys with clinic staff to assess issues that would affect sustainability. Discussion Incorporating the patient’s support system may be an important way to improve treatment retention in medication treatments for OUD. If SPs can serve to support patient retention, this study would significantly advance work to help support the delivery of effective treatments that prevent the devastating consequences associated with OUD. Trial registration This study was registered with ClinicalTrials.gov, NCT04239235. Registered 27 January 2020, https://clinicaltrials.gov/ct2/show/NCT04239235.