Clinical trial NCT02526212: Buprenorphine Group Medical Visits in Primary Care
Official title: Buprenorphine Group Medical Visits for Drug Users at Risk for HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opioid-Related Disorders
Keywords: opioid use disorder
group counseling
office-based buprenorphine treatment
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2015-08-18
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Number of Participants With Opioid Abstinence at 8 Weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of Participants Who Were Retained in Buprenorphine Treatment at 3 Months and 6 Months
timeFrame: 3 months, 6 months
measure: Number of Participants Who Reported Sharing Injection Equipment at 8 Weeks
timeFrame: 8 weeks
measure: Acceptability (Scale)
timeFrame: 16 weeks
measure: Feasibility (Percentage of Visits Attended)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Comprehensive Health Care Center
state: New York
Study officials:
affiliation: Montefiore Medical Center/Albert Einstein College of Medicine
name: Aaron D Fox, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: