MedTrace Logo

Buprenorphine Group Medical Visits in Primary Care

NCT02526212 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-07-07

Study results available
· View outcomes & findings →

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

Conditions

  • Opioid-Related Disorders

Interventions

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.

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

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2019-05-31
Completion
2019-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02526212 on ClinicalTrials.gov