Mindfulness Training vs Recovery Support for Opioid Use, Craving, and Anxiety During Buprenorphine Treatment A Randomized Clinical Trial

Importance During buprenorphine treatment for opioid use disorder (OUD), risk factors for opioid relapse or treatment dropout include comorbid substance use disorder, anxiety, or residual opioid craving. There is a need for a well-powered trial to evaluate virtually delivered groups, including both mindfulness and evidence-based approaches, to address these comorbidities during buprenorphine treatment. Objective To compare the effects of the Mindful Recovery Opioid Use Disorder Care Continuum (M-ROCC) vs active control among adults receiving buprenorphine for OUD. Design, Setting, and Participants This randomized clinical trial was conducted from January 21, 2021, to September 19, 2023. All study procedures were conducted virtually. Participants were randomized 1:1 and blinded to intervention assignments throughout participation. This trial recruited online from 16 US states and was conducted via online platforms. Patients prescribed buprenorphine for OUD were recruited via social media advertisements, flyers, and health care professional referrals. Interventions The M-ROCC program was a 24-week, motivationally adaptive, trauma-informed, mindfulness-based group curriculum. Participants attended a 30-minute informal check-in and 60-minute intervention group each week. The recovery support group control curriculum used 4 evidence-based substance use disorder-focused nonmindfulness approaches and was time and attention matched. Main Outcomes and Measures The primary outcome was the number of 2-week periods with both self-reported and biochemically confirmed abstinence from illicit opioid use during study weeks 13 to 24, which was analyzed with an intention-to-treat approach using generalized estimating equations comparing between-group differences. Results This sample included 196 participants, predominantly female (119 [60.7%]). Mean (SD) age was 41.0 (10.3) years. Opioid use was 13.4% (95% CI, 6.2%-20.5%) in the M-ROCC group and 12.7% (95% CI, 7.5%-18.0%) in the recovery support group, a 0.6% difference (95% CI, -8.2% to 9.5%; P = .89). Cocaine and benzodiazepine use were also not significantly different. Anxiety T scores were reduced across both the M-ROCC and recovery support groups but were not significantly different between groups from baseline to week 24 (1.0; 95% CI, -2.4 to 4.3; P = .57). The M-ROCC participants demonstrated a larger reduction in opioid craving compared with the recovery support group participants: -1.0 (95% CI, -1.7 to -0.2; P = .01; Cohen d = -0.5). Conclusions and Relevance In this study, during buprenorphine treatment comparing mindfulness vs active control, both groups significantly reduced anxiety without significant differences in substance use outcomes. Mindfulness led to significantly greater reductions in residual opioid craving than control. The findings of this study suggest that mindfulness training groups may be recommended for people receiving buprenorphine maintenance therapy who have residual opioid craving. Trial RegistrationClinicalTrials.gov Identifier: NCT04278586