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Buprenorphine Group Medical Visits in Primary Care

Information source: Montefiore Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Opioid-Related Disorders

Intervention: G-BMT (Behavioral); Treatment as usual (Behavioral); Buprenorphine (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Montefiore Medical Center

Official(s) and/or principal investigator(s):
Aaron D Fox, MD, MS, Principal Investigator, Affiliation: Montefiore Medical Center/Albert Einstein College of Medicine

Overall contact:
Jeronimo A Maradiaga, Bachelors, Phone: 7189203782, Email: jmaradia@montefiore.org

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 Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Efficacy - Opioid abstinence (composite measure, yes/no)

Secondary outcome:

Retention in treatment (yes/no)

HIV risk behaviors (scale)

Acceptability (scale)

Feasibility (percentage of visits attended)

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).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Jeronimo A Maradiaga, Bachelors, Phone: 7189203782, Email: jmaradia@montefiore.org

Comprehensive Health Care Center, Bronx, New York 10451, United States; Not yet recruiting
Aaron Fox, MD MS, Phone: 718-920-7173, Email: adfox@montefiore.org
Additional Information

Starting date: April 2016
Last updated: August 14, 2015

Page last updated: August 23, 2015

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