Integrating MOUD in Nonmedical Community Settings (Better Together)
NCT06416020 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2025-12-03
Summary
A multisite effectiveness-implementation study will be conducted in four sites to evaluate interventions to improve engagement and retention in MOUD with buprenorphine treatment persons with Opioid Use Disorder (OUD) in urban neighborhoods with high overdose rates. The investigators hypothesize that treatment with the Better Together Integrated Collaborative Community MOUD care model (BT-MOUD) will result in better retention in treatment than standard-of-care MOUD with buprenorphine provided in the hub buprenorphine clinic only (HC-MOUD Only) through 24 weeks following randomization. BT-MOUD provides MOUD with buprenorphine in nonmedical community-based settings via telemedicine from a hub buprenorphine clinic combined with Recovery Guiding, a manual guided coaching developed for this approach, provided onsite in the community organization.
Conditions
Interventions
- BEHAVIORAL
-
HC-MOUD Only
MOUD with buprenorphine provided in a hub buprenorphine clinic
- BEHAVIORAL
-
BT-MOUD with Buprenorphine
MOUD with buprenorphine provided by a hub buprenorphine provider either in the hub clinic or via telemedicine at a community hub; Recovery Guiding provided to participants
Sponsors & Collaborators
-
University of Illinois at Chicago
collaborator OTHER -
University of Miami
collaborator OTHER -
National Institute on Drug Abuse (NIDA)
collaborator NIH -
The Emmes Company, LLC
collaborator INDUSTRY -
University of Maryland
collaborator OTHER -
Howard University
lead OTHER
Principal Investigators
-
Richard S Schottenfeld, MD · Howard University
-
Viviana Horigian, MD, MHA · University of Miami
-
Niranjan Karnik, MD, PhD · University of Illinois Chicago
-
Denise M. Scott, PhD · Howard University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-26
- Primary Completion
- 2028-07-31
- Completion
- 2028-07-31
Countries
- United States
Study Locations
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