Integrating MOUD in Nonmedical Community Settings (Better Together)

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor: Howard University
Study ID: NCT06416020
Status: Not Yet Recruiting

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Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: ALL
Age: 16 Years - N/A
Healthy Volunteers: Not accepted

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

Study Details

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.

Key Dates

Start date: Jan 26, 2026
Status verified: Nov 2025
Primary completion: Jul 31, 2028
Completion: Jul 31, 2028

Study Design

Enrollment: 400 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Active Comparator: Hub Clinic MOUD with buprenorphine only (HC-MOUD Only)
Participants will receive MOUD with buprenorphine prescribed by providers based at participating hub clinics. MOUD treatment with buprenorphine will follow standard guidelines for induction and maintenance using a sublingual buprenorphine formulation. Hub clinic buprenorphine providers and participants may shift to long acting injection buprenorphine formulations after initial induction with sublingual buprenorphine. If telemedicine prescribing of MOUD with buprenorphine is part of the usual standard of care at the clinic, participants assigned to HC-MOUD Only may be prescribed buprenorphine via telemedicine, following the clinic's usual guidelines. Participants may not receive telemedicine services at the community spokes or Recovery Guiding, which are available only to participants assigned to BTMOUD. All study participants, however, may have access to any services that are routinely provided as part of the MOUD with buprenorphine treatment-as-usual care in the hub clinic.
Experimental: Recovery Guiding / Better Together Medications for Opioid Use Disorder (BT-MOUD) procedures
Better Together Medications for Opioid Use Disorder (BT-MOUD) includes HC-MOUD plus access to telemedicine provision of MOUD with buprenorphine at a nonmedical community organization spoke, plus manual-guided Recovery Guiding provided onsite at the spoke, and plus any other services available at the community organization spoke. Recovery Guiding is a manualized, highly structured, stepwise intervention that uses educational and behavioral tools to provide pragmatic guidance for patients beginning buprenorphine treatment and to address the key recovery misconceptions and dysfunctional behaviors that frequently interfere with recovery efforts of patients initiating medication for opioid use disorder (MOUD) treatment.

Primary Outcome Measure

Buprenorphine MOUD Treatment Retention [ Time Frame: 0-168 days ]

Central Contacts

Richard S Schottenfeld, MD
202-865-6615
[email protected]
Niranjan Karnik, MD, PhD
312-273-0185
[email protected]

Locations (4)

Facility	City	State	ZIP	Site coordinators
Howard University	Washington D.C.	District of Columbia	20059	Richard S Schottenfeld, MD [email protected] 202-865-6615 Denise M Scott, PhD [email protected] 202-806-5264 Richard S Schottenfeld, MD (PRINCIPAL_INVESTIGATOR) Denise M Scott, PhD (SUB_INVESTIGATOR)
University of Miami	Miami	Florida	33136	Viviana Horigian, MD, MHA [email protected] Bijan Lochart-Rodriquez, MBA [email protected] 636-387-8154 Viviana Horigian, MD, MHA (PRINCIPAL_INVESTIGATOR) Jose Szapocznik, PhD (SUB_INVESTIGATOR)
University of Illinois- Chicago	Chicago	Illinois	60608	Niranjan Karnik, MD, PhD 312-273-0185 Konadu Fokuo, PhD [email protected] 312-413-8357 Niranjan Karnik, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of Maryland	Baltimore	Maryland	21223	Eric Weintraub, MD [email protected] 410-328-7919 Heather Fitzsimons, MPH [email protected] 443-462-3400 Eric Weintraub, MD (PRINCIPAL_INVESTIGATOR)

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By research site

Howard University· Washington D.C., DC University of Miami· Miami, FL University of Illinois- Chicago· Chicago, IL University of Maryland· Baltimore, MD

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