NCT02526212

Buprenorphine Group Medical Visits in Primary Care

Buprenorphine Group Medical Visits for Drug Users at Risk for HIV

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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).

Conditions

• Opioid-Related Disorders

Interventions

Type	Name	Description
BEHAVIORAL	G-BMT	The G-BMT intervention will include weekly group visits (for 8 weeks) where 5-10 patients simultaneously receive care from a multidisciplinary team of a generalist physician and a behavioral specialist. Group visits will last 90 minutes and include: BMT education, instruction on self-management skills, peer support, and individual medical management.
BEHAVIORAL	Treatment as usual	Primary care physicians who prescribe buprenorphine will be trained to follow a protocol of BMT intensification, which includes increased visit frequency, referral for mental health counseling, and referral to addiction treatment specialist.
DRUG	Buprenorphine	All participants will continue to receive maintenance treatment with buprenorphine-naloxone

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-05-01
• Completion: 2019-05-01
• First posted: 2015-08-18
• Last updated: 2020-07-07
• Results posted: 2020-07-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study