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

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ClinicalTrials.gov Identifier: NCT02526212
Recruitment Status : Completed
First Posted : August 18, 2015
Last Update Posted : August 19, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Aaron D. Fox, Montefiore Medical Center

Tracking Information
First Submitted Date  ICMJE July 24, 2015
First Posted Date  ICMJE August 18, 2015
Last Update Posted Date August 19, 2019
Actual Study Start Date  ICMJE January 1, 2017
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02526212 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2015)
  • 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.
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Buprenorphine Group Medical Visits in Primary Care
Official Title  ICMJE Buprenorphine Group Medical Visits for Drug Users at Risk for HIV
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

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Opioid-Related Disorders
Intervention  ICMJE
  • 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)
  • 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)
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: G-BMT
    • Drug: Buprenorphine
  • 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.
    Interventions:
    • Behavioral: Treatment as usual
    • Drug: Buprenorphine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 16, 2019)
18
Original Estimated Enrollment  ICMJE
 (submitted: August 14, 2015)
80
Actual Study Completion Date  ICMJE May 2019
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02526212
Other Study ID Numbers  ICMJE 2014-3580
R34DA039041 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aaron D. Fox, Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Aaron D Fox, MD, MS Montefiore Medical Center/Albert Einstein College of Medicine
PRS Account Montefiore Medical Center
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP