G-BMT: Buprenorphine Group Medical Visits in Primary Care

• Sponsor: Montefiore Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02526212
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 18
• Location: 1
• Arms: 2
• Actual Duration (Months): 27.9
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Opioid-Related Disorders	Behavioral: G-BMT; Behavioral: Treatment as usual; Drug: Buprenorphine	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Buprenorphine Group Medical Visits for Drug Users at Risk for HIV
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: May 1, 2019
• Actual Study Completion Date: May 1, 2019

Arms and Interventions

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.	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.; Drug: Buprenorphine; All participants will continue to receive maintenance treatment with buprenorphine-naloxone; Other Names: Buprenorphine Maintenance Treatment (BMT)

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Opioid Abstinence at 8 Weeks [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.

Secondary Outcome Measures

1. Number of Participants Who Were Retained in Buprenorphine Treatment at 3 Months and 6 Months [3 months, 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.

2. Number of Participants Who Reported Sharing Injection Equipment at 8 Weeks [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.

3. Acceptability (Scale) [16 weeks]

   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.

4. Feasibility (Percentage of Visits Attended) [8 weeks]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Comprehensive Health Care Center	Bronx	New York	United States	10451

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Aaron D Fox, MD, MS, Montefiore Medical Center/Albert Einstein College of Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 16, 2018

More Information

Publications

None provided.

• Responsible Party: Aaron D. Fox, Assistant Professor of Medicine, Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT02526212
• Other Study ID Numbers: 2014-3580; R34DA039041
• First Posted: Aug 18, 2015
• Last Update Posted: Jul 7, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Aaron D. Fox, Assistant Professor of Medicine, Montefiore Medical Center: opioid use disorder; group counseling; office-based buprenorphine treatment
• Additional relevant MeSH terms: Opioid-Related Disorders; Buprenorphine

Study Results

Participant Flow

Arm/Group Title	G-BMT, Buprenorphine	Treatment as Usual, Buprenorphine
Arm/Group Description	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. 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. Buprenorphine: All participants will continue to receive maintenance treatment with buprenorphine-naloxone	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: 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: All participants will continue to receive maintenance treatment with buprenorphine-naloxone
Period Title: Overall Study
STARTED	10	8
COMPLETED	8	7
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	G-BMT, Buprenorphine	Treatment as Usual, Buprenorphine	Total
Arm/Group Description	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. 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. Buprenorphine: All participants will continue to receive maintenance treatment with buprenorphine-naloxone	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: 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: All participants will continue to receive maintenance treatment with buprenorphine-naloxone	Total of all reporting groups
Overall Participants	10	8	18
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	54.5	50.5	52
Sex: Female, Male (Count of Participants)
Female	1 10%	0 0%	1 5.6%
Male	9 90%	8 100%	17 94.4%
Race/Ethnicity, Customized (Count of Participants)
Hispanic	9 90%	8 100%	17 94.4%
Non-Hispanic Black	1 10%	0 0%	1 5.6%
Non-Hispanic White	0 0%	0 0%	0 0%
Education (Count of Participants)
High School	6 60%	6 75%	12 66.7%
College	4 40%	2 25%	6 33.3%
Housing Status (Count of Participants)
Unstable Housing	6 60%	6 75%	12 66.7%
Rental Apartment	4 40%	2 25%	6 33.3%
Recent Incarceration (Count of Participants)
Count of Participants [Participants]	2 20%	1 12.5%	3 16.7%
Unemployed (Count of Participants)
Count of Participants [Participants]	8 80%	7 87.5%	15 83.3%
Parole (Count of Participants)
Count of Participants [Participants]	2 20%	1 12.5%	3 16.7%
Alcohol use (Count of Participants)
Count of Participants [Participants]	4 40%	2 25%	6 33.3%
Heroin use (Count of Participants)
Count of Participants [Participants]	8 80%	6 75%	14 77.8%
Any illicit opioid use (Count of Participants)
Count of Participants [Participants]	8 80%	7 87.5%	15 83.3%
Cocaine use (Count of Participants)
Count of Participants [Participants]	4 40%	2 25%	6 33.3%
Injection drug use (Count of Participants)
Count of Participants [Participants]	2 20%	2 25%	4 22.2%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Opioid Abstinence at 8 Weeks
Description	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.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

Intention to treat analysis - missing urine drug toxicology tests are considered to be positive for illicit opioids

Arm/Group Title	G-BMT, Buprenorphine	Treatment as Usual, Buprenorphine
Arm/Group Description	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. 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. Buprenorphine: All participants will continue to receive maintenance treatment with buprenorphine-naloxone	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: 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: All participants will continue to receive maintenance treatment with buprenorphine-naloxone
Measure Participants	10	8
Count of Participants [Participants]	0 0%	1 12.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	G-BMT, Buprenorphine, Treatment as Usual, Buprenorphine
	Comments	Due to the small sample size, planned analyses that assessed for clustering by group assignment or primary care physician could not be conducted. Chi square using fisher's exact test was conducted to investigate differences in abstinence between study arms.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.44
	Comments
	Method	Fisher Exact
	Comments

2. Secondary Outcome

Title	Number of Participants Who Were Retained in Buprenorphine Treatment at 3 Months and 6 Months
Description	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.
Time Frame	3 months, 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	G-BMT, Buprenorphine	Treatment as Usual, Buprenorphine
Arm/Group Description	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. 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. Buprenorphine: All participants will continue to receive maintenance treatment with buprenorphine-naloxone	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: 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: All participants will continue to receive maintenance treatment with buprenorphine-naloxone
Measure Participants	10	8
3 month retention	8 80%	7 87.5%
6 month retention	8 80%	6 75%

3. Secondary Outcome

Title	Number of Participants Who Reported Sharing Injection Equipment at 8 Weeks
Description	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.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

8 week data missing for 4 participants in G-BMT arm and 3 participants in the treatment as usual arm

Arm/Group Title	G-BMT, Buprenorphine	Treatment as Usual, Buprenorphine
Arm/Group Description	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. 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. Buprenorphine: All participants will continue to receive maintenance treatment with buprenorphine-naloxone	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: 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: All participants will continue to receive maintenance treatment with buprenorphine-naloxone
Measure Participants	6	6
Count of Participants [Participants]	0 0%	0 0%

4. Secondary Outcome

Title	Acceptability (Scale)
Description	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.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Acceptability data missing for 4 participants in G-BMT arm and 3 participants in the treatment as usual arm

Arm/Group Title	G-BMT, Buprenorphine	Treatment as Usual, Buprenorphine
Arm/Group Description	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. 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. Buprenorphine: All participants will continue to receive maintenance treatment with buprenorphine-naloxone	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: 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: All participants will continue to receive maintenance treatment with buprenorphine-naloxone
Measure Participants	6	6
Mean (Standard Deviation) [units on a scale]	4.6 (0.29)	4.8 (0.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	G-BMT, Buprenorphine, Treatment as Usual, Buprenorphine
	Comments	Each of the 17 items were rated on a scale from 1 to 5. For each participant, the scores from these items were summed and divided by 17 for an average satisfaction score. The average satisfaction score was compared between study arms.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.20
	Comments
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

Title	Feasibility (Percentage of Visits Attended)
Description	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
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	G-BMT, Buprenorphine	Treatment as Usual, Buprenorphine
Arm/Group Description	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. 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. Buprenorphine: All participants will continue to receive maintenance treatment with buprenorphine-naloxone	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: 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: All participants will continue to receive maintenance treatment with buprenorphine-naloxone
Measure Participants	10	8
Median (Inter-Quartile Range) [percentage of visits attended]	69	71

Adverse Events

Time Frame	Medical record review was conducted after 24 weeks had elapsed following enrollment.
Arm/Group Title	G-BMT, Buprenorphine		Treatment as Usual, Buprenorphine
Arm/Group Description	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. 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. Buprenorphine: All participants will continue to receive maintenance treatment with buprenorphine-naloxone		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: 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: All participants will continue to receive maintenance treatment with buprenorphine-naloxone
All Cause Mortality
	G-BMT, Buprenorphine		Treatment as Usual, Buprenorphine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		1/8 (12.5%)
Serious Adverse Events
	G-BMT, Buprenorphine		Treatment as Usual, Buprenorphine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	G-BMT, Buprenorphine		Treatment as Usual, Buprenorphine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/8 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.