Integrating MOUD in Nonmedical Community Settings (Better Together)

NCT ID: NCT06416020

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-26
• Study Completion Date: 2028-07-31

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.

Detailed Description

This multi-site hybrid Type 1 effectiveness-implementation study conducted in Washington, District of Columbia (DC), Chicago, Miami-Dade County and Baltimore will evaluate: 1) the effectiveness of providing MOUD with buprenorphine onsite (via telemedicine from a hub buprenorphine clinic) combined with Recovery Guiding in nonmedical community-based settings (the Better Together Integrated Collaborative Community MOUD care model - BT-MOUD) compared to standard-of-care MOUD with buprenorphine provided in the hub buprenorphine clinic only (HC-MOUD Only) and 2) BT-MOUD implementation barriers and facilitators. In the BT-MOUD intervention, community sites serve as "spokes" for telemedicine provision of MOUD by buprenorphine providers based in a "hub" buprenorphine clinic. A trained and supervised Recovery Guide with roots or connections with the community provides manual-guided Recovery Guiding on-site in the community site. Recovery Guiding includes psychoeducation (about OUD and effective buprenorphine MOUD) and behavioral counseling to promote engagement in MOUD with buprenorphine, retention in care, medication adherence, and behavioral change supportive of recovery. In HC-MOUD Only, participants will receive MOUD with buprenorphine and other available services in the hub buprenorphine clinic only. A Peer Outreach Specialist (POS) will assist with outreach and recruitment of all participants across conditions and with maintaining high rates of follow-up in research assessments. This study will test the hypothesis that BT-MOUD is more effective than HC-MOUD Only in retaining persons with OUD in MOUD with buprenorphine through six months post-randomization.

Conditions

Opioid Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

HC-MOUD Only

Intervention Type: BEHAVIORAL

MOUD with buprenorphine provided in a hub buprenorphine clinic

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.

Group Type: EXPERIMENTAL

BT-MOUD with Buprenorphine

Intervention Type: 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

Interventions

HC-MOUD Only

MOUD with buprenorphine provided in a hub buprenorphine clinic

Intervention Type: 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

Intervention Type: BEHAVIORAL

Other Intervention Names

Hub Clinic MOUD with Buprenorphine; Better Together MOUD with Buprenorphine

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 10 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 either taken prescribed MOUD as an outpatient for more than 10 consecutive days OR received injectable MOUD that covers 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

The Emmes Company, LLC

INDUSTRY

Sponsor Role: collaborator

University of Maryland

OTHER

Sponsor Role: collaborator

Howard University

OTHER

Sponsor Role: lead

Responsible Party

Richard Schottenfeld

Professor and Chair, Department of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard S Schottenfeld, MD

Role: PRINCIPAL_INVESTIGATOR

Howard University

Viviana Horigian, MD, MHA

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Niranjan Karnik, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois Chicago

Denise M. Scott, PhD

Role: STUDY_DIRECTOR

Howard University

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

Countries

United States

Central Contacts

Richard S Schottenfeld, MD

Role: CONTACT

richard.schottenfeld@howard.edu

202-865-6615

Niranjan Karnik, MD, PhD

Role: CONTACT

nkarnik@uic.edu

312-273-0185

Facility Contacts

Richard S Schottenfeld, MD

Role: primary

richard.schottenfeld@howard.edu

202-865-6615

Denise M Scott, PhD

Role: backup

d_m_scott@howard.edu

202-806-5264 ext. Scott

Viviana Horigian, MD, MHA

Role: primary

vhorigian@med.miami.edu

Bijan Lochart-Rodriquez, MBA

Role: backup

bxl@med.miami.edu

636-387-8154

Niranjan Karnik, MD, PhD

Role: primary

312-273-0185

Konadu Fokuo, PhD

Role: backup

jkfoko@uic.edu

312-413-8357

Eric Weintraub, MD

Role: primary

eweintra@som.umaryland.edu

410-328-7919

Heather Fitzsimons, MPH

Role: backup

hfitzsimons@som.umaryland.edu

443-462-3400

Other Identifiers

UG1DA013720

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIDA CTN Protocol 0144

Identifier Type: -

Identifier Source: org_study_id