Buprenorphine Group Medical Visits in Primary Care — G-BMT  

Opioid-Related Disorders Clinical Trial

Official title: Buprenorphine Group Medical Visits for Drug Users at Risk for HIV

Status Completed

Clinical Trial Summary

The primary goal of this research is to improve the effectiveness of buprenorphine maintenance treatment (BMT) within primary care.

Investigators propose that providing BMT as part of a group medical visit (instead of an individual visit) will improve treatment outcomes for patients with persistent opioid abuse, because members become accountable to the group, are exposed to beneficial habits of others (i.e. positive deviance), and can receive efficacious behavioral interventions concomitantly with medical management

Clinical Trial Description

Investigators have developed a preliminary model of BMT group medical visits, conducted focus groups with BMT patients and providers, and will use this data to develop a manualized group-based BMT intervention (G-BMT). Investigators will then conduct a randomized controlled trial (RCT) of the G-BMT intervention within primary care to preliminarily test its efficacy, acceptability, and feasibility. Participants who have persistent opioid abuse while receiving BMT in primary care will be randomized to the G-BMT intervention (40 participants in 5 groups) or to intensify BMT (treatment as usual) with their individual primary care physician (40 participants).

Hypothesis: In a 16-week RCT of G-BMT, participants who receive the G-BMT intervention (vs. treatment as usual) will have higher abstinence rates (primary outcome, efficacy), fewer HIV risk behaviors (efficacy), and greater satisfaction with treatment (acceptability) and adherence to medical visits (feasibility). ;

Related Conditions & MeSH terms

• Opioid-Related Disorders

• NCT number: NCT02526212
• Study type: Interventional
• Source: Montefiore Medical Center
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2017
• Completion date: May 2019