Recruiting

BT-MOUD with Buprenorphine

Sponsor:

Howard University

Code:

NCT06416020

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

HC-MOUD Only

BT-MOUD with Buprenorphine

Study Details

Brief 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

Opioid Use Disorder

Study ID

NCT06416020

Start date

Apr 15, 2026

Status verified date

Oct, 2026

Completion date

Jun 1, 2029

Anticipated

Primary completion date

Jun 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

HC-MOUD Only

MOUD with buprenorphine provided in a hub buprenorphine clinic

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Richard S Schottenfeld, MD

202-865-6615richard.schottenfeld@howard.edu

Niranjan Karnik, MD, PhD

312-273-0185nkarnik@uic.edu

Locations

Howard University

Recruiting

Washington D.C., District of Columbia, United States, 20059

Contacts

Richard S Schottenfeld, MD

202-865-6615richard.schottenfeld@howard.edu

Denise M Scott, PhD

202-806-5264d_m_scott@howard.edu

Principal Investigator:

Richard S Schottenfeld, MD

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Viviana Horigian, MD, MHA

vhorigian@med.miami.edu

Bijan Lochart-Rodriquez, MBA

636-387-8154bxl@med.miami.edu

Principal Investigator:

Viviana Horigian, MD, MHA

University of Illinois- Chicago

Recruiting

Chicago, Illinois, United States, 60608

Contacts

Niranjan Karnik, MD, PhD

312-273-0185

Konadu Fokuo, PhD

312-413-8357jkfoko@uic.edu

Principal Investigator:

Niranjan Karnik, MD, PhD

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21223

Contacts

Eric Weintraub, MD

410-328-7919eweintra@som.umaryland.edu

Heather Fitzsimons, MPH

443-462-3400hfitzsimons@som.umaryland.edu

Principal Investigator:

Eric Weintraub, MD

More Information

Sponsor

Howard University

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

  • MOUD
  • OUD
  • Buprenorphine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-14. This information was provided to ClinicalTrials.gov by Howard University on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.