An initial randomized controlled trial of a Combined Medication and Behavioral Activation Treatment (CoMBAT) for people with opioid use disorder.

introductionOpioid use disorder is a chronic, relapsing disease and a major source of morbidity and mortality in the U.S. Medications for opioid use disorder (MOUD) have been shown to reduce opioid use; however, MOUD maintenance is often suboptimal. Depression is a well-documented risk factor for MOUD treatment disengagement; thus, behavioral interventions to address depression and support ongoing MOUD use in community settings are warranted.

methodsWe evaluated the feasibility, acceptability, and preliminary efficacy of the CoMBAT (Combined Medication and Behavioral Activation Treatment) intervention via a pilot randomized controlled trial. We hypothesized that the CoMBAT intervention, which uses behavioral activation, motivational interviewing, and problem-solving techniques, would be feasible and acceptable to participants and decrease depression, increase goal-directed activity, improve MOUD care engagement, and reduce opioid use among adults with depressive symptoms who had a missed dose or clinical MOUD visit in the past 30 days. We enrolled 32 participants prescribed methadone or buprenorphine in the community; each received 2 health navigation and substance use counseling sessions (HN_SUC) before being randomized into (a) the 8-session CoMBAT intervention + HN_SUC + treatment as usual or (b) HN_SUC + treatment as usual only. The primary outcomes were intervention feasibility and acceptability. Preliminary efficacy measures included self-reported past-30-day MOUD doses and clinical visits, depressive symptoms, behavioral activation; and opioid-positive urinalysis; each assessed at baseline and 3- and 6-month follow-up visits.

resultsThe intervention was feasible (88 % of intervention sessions completed; 100 % retention at 6 months) and acceptable (86 % of intervention participants were satisfied/very satisfied with the intervention at 3-months; and intervention participants had a high level of alliance with their counselor at the mid-point: mean = 5.7 out of 7 [SD = 1.3] and end of their treatment: mean = 5.5 out of 7 [SD = 1.1]. At 6-months, intervention participants reported fewer missed MOUD doses and visits, less depressive symptoms, greater behavioral activation scores, and a lower percentage of opioid-positive toxicology screens relative to the control condition.

conclusionFindings provide evidence of intervention feasibility and acceptability and demonstrate initial efficacy for ongoing MOUD care engagement, depressive symptom reduction, increased behavioral activity, and reduced opioid use. Future intervention testing in a fully-powered efficacy trial is warranted.