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Trial record 2 of 13 for:    buprenorphine | Recruiting Studies | United States | Phase 3, 4

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

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ClinicalTrials.gov Identifier: NCT02526212
Recruitment Status : Recruiting
First Posted : August 18, 2015
Last Update Posted : November 21, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Aaron D. Fox, Montefiore Medical Center

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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 : January 1, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


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 Name: Group Buprenorphine Maintenance Treatment (G-BMT)

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




Primary Outcome Measures :
  1. Efficacy - Opioid abstinence (composite measure, yes/no) [ Time Frame: 8 weeks ]
    Opioid abstinence will be based on 30 day self-reported opioid use at 8 weeks and the results of observed urine toxicology tests at 8 weeks following protocol initiation. Abstinence (yes) will require no self-reported opioid use, and negative urine toxicology test for opiates, methadone, and oxycodone.


Secondary Outcome Measures :
  1. Retention in treatment (yes/no) [ Time Frame: 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. HIV risk behaviors (scale) [ Time Frame: 8 weeks, 16 weeks ]
    The AIDS risk inventory will be used to measure sexual and injection-related risk behaviors at completion of the G-BMT intervention and 2 months later.

  3. Acceptability (scale) [ Time Frame: 16 weeks ]
    Satisfaction with BMT will be measured on a 5-point Likert scale for participants following completion of the intervention.

  4. Feasibility (percentage of visits attended) [ Time Frame: 8 weeks ]
    Visit adherence will be measured as the number of buprenorphine visits attended divided by the number of buprenorphine visits required per protocol



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02526212


Contacts
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Contact: Whitney Y Colon, Bachelors 7189205682 whcolon@montefiore.org

Locations
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United States, New York
Comprehensive Health Care Center Recruiting
Bronx, New York, United States, 10451
Contact: Aaron Fox, MD MS    718-920-7173    adfox@montefiore.org   
Sponsors and Collaborators
Montefiore Medical Center
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Aaron D Fox, MD, MS Montefiore Medical Center/Albert Einstein College of Medicine

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Responsible Party: Aaron D. Fox, Assistant Professor of Medicine, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02526212     History of Changes
Other Study ID Numbers: 2014-3580
R34DA039041 ( U.S. NIH Grant/Contract )
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aaron D. Fox, Montefiore Medical Center:
opioid use disorder
group counseling
office-based buprenorphine treatment

Additional relevant MeSH terms:
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Buprenorphine
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists