Expired Study
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Bronx, New York 10451


Purpose:

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


Study summary:

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).


Criteria:

Inclusion Criteria: 1. Currently receiving BMT at Montefiore community health center (CHC). 2. Received BMT for 12 or more weeks. 3. 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.) 4. Fluent in English of Spanish Exclusion Criteria: 1) Pregnancy


NCT ID:

NCT02526212


Primary Contact:

Principal Investigator
Aaron D Fox, MD, MS
Montefiore Medical Center/Albert Einstein College of Medicine


Backup Contact:

N/A


Location Contact:

Bronx, New York 10451
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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