RESUMO
BACKGROUND: Office-based opioid treatment with buprenorphine has emerged as a popular evidence-based treatment for opioid use disorder. Unfortunately, psychosocial stress, anxiety, pain, and co-morbid substance use increase patients' risk for relapse. We designed this study to compare the effects of complementing buprenorphine treatment with 24 weeks of a live-online Mindful Recovery Opioid Care Continuum (M-ROCC) group to a time and attention-matched, live-online Recovery Support Group (RSG) active control condition. METHODS: We plan to enroll a maximum of N = 280 and randomize at least N = 192 patients prescribed buprenorphine through referrals from office-based and telemedicine buprenorphine treatment providers and social media advertisements. Participants will be randomly assigned to M-ROCC or RSG and will be blinded to their treatment condition. The primary outcome for this study will be biochemically confirmed periods of abstinence from illicit opioids, as measured by self-reported use and randomly collected, video-observed oral fluid toxicology testing during the final 12 weeks of study participation. Secondary outcomes include changes in Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety and pain interference scores between baseline and week 24. RESULTS: The trial was funded by the National Institutes of Health, HEAL Initiative through NCCIH (R33AT010125). Data collection is projected to end by September 2023, and we expect publication of results in 2024. CONCLUSION: If the M-ROCC intervention is found to be effective in this format, it will demonstrate that live-online mindfulness groups can improve outcomes and address common co-morbidities like anxiety and pain during buprenorphine treatment.