Buprenorphine Group Medical Visits in Primary Care

NCT ID: NCT02526212

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2019-05-31

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).

Conditions

Opioid-Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

G-BMT

Intervention Type: BEHAVIORAL

The G-BMT intervention will include weekly group visits (for 8 weeks) where 5-10 patients simultaneously receive care from a multidisciplinary team of a generalist physician and a behavioral specialist. Group visits will last 90 minutes and include: BMT education, instruction on self-management skills, peer support, and individual medical management.

Buprenorphine

Intervention Type: DRUG

All participants will continue to receive maintenance treatment with buprenorphine-naloxone

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.

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: BEHAVIORAL

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.

Buprenorphine

Intervention Type: DRUG

All participants will continue to receive maintenance treatment with buprenorphine-naloxone

Interventions

G-BMT

The G-BMT intervention will include weekly group visits (for 8 weeks) where 5-10 patients simultaneously receive care from a multidisciplinary team of a generalist physician and a behavioral specialist. Group visits will last 90 minutes and include: BMT education, instruction on self-management skills, peer support, and individual medical management.

Intervention Type: BEHAVIORAL

Treatment as usual

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 Type: BEHAVIORAL

Buprenorphine

All participants will continue to receive maintenance treatment with buprenorphine-naloxone

Intervention Type: DRUG

Other Intervention Names

Group Buprenorphine Maintenance Treatment (G-BMT); Buprenorphine Maintenance Treatment (BMT)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Aaron D. Fox

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aaron D Fox, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center/Albert Einstein College of Medicine

Locations

Comprehensive Health Care Center

The Bronx, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R34DA039041

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2014-3580

Identifier Type: -

Identifier Source: org_study_id