Adjunctive Psychosocial Interventions and Opioid Abstinence Among Patients Receiving Buprenorphine: A Randomized Clinical Trial.

Abstract

Adjunctive psychosocial treatments are recommended for many using medications for opioid use disorder (MOUD), but it is unclear which approaches can best enhance treatment outcomes. To evaluate the comparative effectiveness of 2 psychosocial treatments, peer recovery support (PRS) and cognitive-behavioral therapy (CBT), on opioid abstinence when used as adjunctive therapies to office-based buprenorphine treatment in adults with opioid use disorder (OUD). This randomized clinical trial included US adults diagnosed with OUD referred for care at 5 federally qualified health centers with office-based addiction treatment programs by their clinicians from 2020 to 2024. Participants were followed up for 1 year postenrollment. Analyses were conducted September through November 2025. Participants were randomized to 1 of 4 conditions: MOUD treatment as usual, MOUD plus 12 weeks of CBT, MOUD plus 12 weeks of PRS, or MOUD plus 12 weeks of CBT and PRS. The CBT intervention consisted of 12 individual, manualized sessions over 12 weeks focused on goal setting, functional analysis, cognitive restructuring, skill building, and relapse prevention. The PRS intervention required at least once-weekly contact for 12 weeks and focused on shared lived experience, goal setting, and navigation assistance to meet immediate needs. In the CBT plus PRS condition, participants were assigned to 12 weeks of concurrent CBT and PRS. The primary outcome was urinalysis-confirmed opioid abstinence at 3, 6, 9, and 12 months. A total of 340 participants were included (mean [SD] age, 42.3 [10.9] years; 100 female [29.4%]). Neither CBT (odds ratio [OR], 1.16; 95% CI, 0.63-2.13), PRS (OR, 0.87; 95% CI, 0.48-1.59), nor their interaction (OR, 0.99; 95% CI, 0.30-3.27) was associated with urinalysis-confirmed opioid use. In this randomized clinical trial, CBT and PRS had no effect on rates of opioid abstinence in the year following the initiation of MOUD. ClinicalTrials.gov Identifier: NCT04257214.