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Integrating MOUD in Nonmedical Community Settings (Better Together)

Sponsor: Howard University • ClinicalTrials.gov ID: NCT06416020

Registry updated: 2026-10-13

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Description

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.

Interventions

HC-MOUD Only (Behavioral)
MOUD with buprenorphine provided in a hub buprenorphine clinic
BT-MOUD with Buprenorphine (Behavioral)
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

Eligibility criteria

Inclusion Criteria 1. Be 16 years of age or older 2. Has been newly prescribed MOUD with buprenorphine by a hub clinic provider no more than 90 days before the day of randomization or on the day of randomization. \[Note that the "start" of a "current, new treatment episode" of MOUD with buprenorphine is defined as the date MOUD with buprenorphine was prescribed by a hub clinic provider.\] 3. Is willing and able to provide written informed consent 4. Is willing and able to provide reliable locator information to facilitate contacting the participant for research follow-up assessments 5. Speaks English well enough to be able to comprehend the study procedures and complete the assessments Exclusion Criteria: 1. In the 30 days prior to receiving the prescription for MOUD with buprenorphine from the hub clinic provider, has been covered by MOUD (oral, sublingual, injection) as an outpatient for more than 10 consecutive days. \[Note that receipt of MOUD in a hospital, residential treatment, or carceral setting would not trigger exclusion.\] 2. Plans to move out of the area or anticipate not being able to remain in the study for 6 months 3. Is currently in jail, prison, or other overnight facility as required by a court of law or have pending legal action that could prevent participation in study activities 4. Has been previously enrolled in CTN-0144 or CTN-0088 or is currently enrolled in another clinical trial for treatment of OUD

Conditions

Opioid Use Disorder

Locations

Howard University — Washington D.C., District of Columbia, United States
University of Miami — Miami, Florida, United States
University of Illinois- Chicago — Chicago, Illinois, United States
University of Maryland — Baltimore, Maryland, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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