Buprenorphine Group Medical Visits for Drug Users at Risk for HIV
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Montefiore Medical Center
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Number of Participants With Opioid Abstinence at 8 Weeks
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Currently receiving BMT at Montefiore community health center (CHC).
- •Received BMT for 12 or more weeks.
- •Persistent opioid abuse (positive toxicology for an unprescribed opioid at most recent test or in 50% or more of collected tests in the previous 6 months.)
- •Fluent in English of Spanish
Exclusion Criteria
- •1) Pregnancy
Arms & Interventions
Treatment as usual, Buprenorphine
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.
Intervention: Treatment as usual (Behavioral)
G-BMT, Buprenorphine
This arm will receive the G-BMT intervention, which will include group visits where 5-10 patients simultaneously receive care from a multidisciplinary team of a generalist physician and a behavioral specialist. The G-BMT intervention will last 90 minutes and include: BMT education, instruction on self-management skills, peer support, and individual medical management.
Intervention: G-BMT (Behavioral)
G-BMT, Buprenorphine
This arm will receive the G-BMT intervention, which will include group visits where 5-10 patients simultaneously receive care from a multidisciplinary team of a generalist physician and a behavioral specialist. The G-BMT intervention will last 90 minutes and include: BMT education, instruction on self-management skills, peer support, and individual medical management.
Intervention: Buprenorphine (Drug)
Treatment as usual, Buprenorphine
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.
Intervention: Buprenorphine (Drug)
Outcomes
Primary Outcomes
Number of Participants With Opioid Abstinence at 8 Weeks
Time Frame: 8 weeks
Opioid abstinence will be based on self-reported opioid use in the prior 30 days at the 8 week visit and the results of urine toxicology test at the 8 week visit. Abstinence (yes) will require no self-reported opioid use and negative urine toxicology test for opiates, methadone, and oxycodone.
Secondary Outcomes
- Number of Participants Who Were Retained in Buprenorphine Treatment at 3 Months and 6 Months(3 months, 6 months)
- Number of Participants Who Reported Sharing Injection Equipment at 8 Weeks(8 weeks)
- Acceptability (Scale)(16 weeks)
- Feasibility (Percentage of Visits Attended)(8 weeks)
Investigators
Aaron D. Fox
Assistant Professor of Medicine
Montefiore Medical Center