Buprenorphine Group Medical Visits in Primary Care

Study Overview
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Brief Summary
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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
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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).

Official Title
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Buprenorphine Group Medical Visits for Drug Users at Risk for HIV

Conditions
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Opioid-Related Disorders

Intervention / Treatment
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* Behavioral: G-BMT
* Behavioral: Treatment as usual
* Drug: Buprenorphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 1) Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G-BMT, Buprenorphine<br>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<br>* 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.<br>* Other names: Group Buprenorphine Maintenance Treatment (G-BMT);Drug: Buprenorphine<br>* All participants will continue to receive maintenance treatment with buprenorphine-naloxone<br>* Other names: Buprenorphine Maintenance Treatment (BMT);|
| Active Comparator: Treatment as usual, Buprenorphine<br>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<br>* 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.<br>Drug: Buprenorphine<br>* All participants will continue to receive maintenance treatment with buprenorphine-naloxone<br>* Other names: Buprenorphine Maintenance Treatment (BMT);|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid use disorder, group counseling, office-based buprenorphine treatment