Buprenorphine Group Medical Visits in Primary Care (G-BMT)

Buprenorphine Group Medical Visits for Drug Users at Risk for HIV

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

Study Overview

• Status: Completed
• Conditions: Opioid-Related Disorders
• Intervention / Treatment: Behavioral: G-BMT; Drug: Buprenorphine; Behavioral: Treatment as usual

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).

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10451
      • Comprehensive Health Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; Other Names: Group Buprenorphine Maintenance Treatment (G-BMT); Drug: Buprenorphine; All participants will continue to receive maintenance treatment with buprenorphine-naloxone; Other Names: Buprenorphine Maintenance Treatment (BMT)
Active Comparator: 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.	Drug: Buprenorphine; All participants will continue to receive maintenance treatment with buprenorphine-naloxone; Other Names: Buprenorphine Maintenance Treatment (BMT); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Were Retained in Buprenorphine Treatment at 3 Months and 6 Months	Retention is defined as having a medical visit or active buprenorphine prescription 12-16 weeks (3 month retention) and 24-28 weeks (6 month retention) after protocol initiation.	3 months, 6 months
Number of Participants Who Reported Sharing Injection Equipment at 8 Weeks	We used the HIV risk measure from the NIDA Seek, Test, Treat, and Retain for Vulnerable Populations study. Items for sexual risk behavior are from the Women's Health CoOp Baseline Questionnaire. Items for injection risk behavior are from the STTR Criminal Justice instrument. We will report the number of participants reporting sharing of injection equipment at 8 weeks following enrollment.	8 weeks
Acceptability (Scale)	Satisfaction with BMT will be measured on a 5-point Likert scale for participants following completion of the intervention. We used 17 items from the Primary Care Buprenorphine Satisfaction Scale. Each item addressed satisfaction with a specific component of buprenorphine treatment, which participants rated on a scale from 1 (very unsatisfied) to 5 (very satisfied). A higher score indicates greater satisfaction.	16 weeks
Feasibility (Percentage of Visits Attended)	Visit adherence will be measured as the number of buprenorphine visits attended divided by the number of buprenorphine visits required per protocol and multiplied by 100 to give a percentage	8 weeks

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Aaron D Fox, MD, MS, Montefiore Medical Center/Albert Einstein College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: July 24, 2015
• First Submitted That Met QC Criteria: August 14, 2015
• First Posted (Estimate): August 18, 2015

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: June 19, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: opioid use disorder; group counseling; office-based buprenorphine treatment
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine
• Other Study ID Numbers: 2014-3580; R34DA039041 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No