Buprenorphine Group Medical Visits in Primary Care

NCT02526212 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 2014-3580R34DA039041
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Opioid-Related Disorders

Keywords

opioid use disorder; group counseling; office-based buprenorphine treatment

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Opioid Abstinence at 8 Weeks

  Opioid abstinence will be based on self-reported opioid use in the prior 30 days at the 8 week visit and the results of urine toxicology test at the 8 week visit. Abstinence (yes) will require no self-reported opioid use and negative urine toxicology test for opiates, methadone, and oxycodone.

  8 weeks

Secondary Outcomes (4)

• Number of Participants Who Were Retained in Buprenorphine Treatment at 3 Months and 6 Months

  3 months, 6 months

• Number of Participants Who Reported Sharing Injection Equipment at 8 Weeks

  8 weeks

• Acceptability (Scale)

  16 weeks

• Feasibility (Percentage of Visits Attended)

  8 weeks

Study Arms (2)

G-BMT, Buprenorphine

EXPERIMENTAL

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.

Behavioral: G-BMT; Drug: Buprenorphine

Treatment as usual, Buprenorphine

ACTIVE COMPARATOR

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.

Behavioral: Treatment as usual; Drug: Buprenorphine

Interventions

G-BMT 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.

Also known as: Group Buprenorphine Maintenance Treatment (G-BMT)

G-BMT, Buprenorphine

Treatment as usual 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.

Treatment as usual, Buprenorphine

Buprenorphine DRUG

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

Also known as: Buprenorphine Maintenance Treatment (BMT)

G-BMT, Buprenorphine; Treatment as usual, Buprenorphine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently receiving BMT at Montefiore community health center (CHC).
• Received BMT for 12 or more weeks.
• 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.)
• Fluent in English of Spanish

You may not qualify if:

• \) Pregnancy

Sponsors & Collaborators

• Montefiore Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Comprehensive Health Care Center

The Bronx, New York, 10451, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Therapeutics; Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Due to the small sample size, several analyses were not conducted as planned. Narrow inclusion criteria limited recruitment. Though efficacy data is limited, this pilot study did provide useful information about group feasibility and acceptability.

Results Point of Contact

• Title: Aaron Fox, Principal Investigator
• Organization: Montefiore Medical Center-Albert Einstein College of Medicine

adfox@montefiore.org

718-920-7173

Study Officials

• Aaron D Fox, MD, MS

  Montefiore Medical Center/Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2015
• First Posted: August 18, 2015
• Study Start: January 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: June 22, 2026
• Results First Posted: July 7, 2020

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)