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
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