Integrating MOUD in Nonmedical Community Settings (Better Together)

NCT06416020 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-12-03

No results posted yet for this study

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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Entities

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 NCT06416020 on ClinicalTrials.gov