Integrating MOUD in Nonmedical Community Settings (Better Together)
2 other identifiers
interventional
400
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2024
CompletedFirst Posted
Study publicly available on registry
May 16, 2024
CompletedStudy Start
First participant enrolled
January 26, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
December 3, 2025
November 1, 2025
2.4 years
April 19, 2024
November 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Buprenorphine MOUD Treatment Retention
Duration of continuous participation in the hub clinic provided buprenorphine treatment
0-168 days
Secondary Outcomes (7)
Self-reported adherence to MOUD with buprenorphine
0-168 days
Self-reported nonmedical opioid use
0-168 days
Self-reported nonmedical other drug use
0-168 days
Urine Toxicology
Months 1,2 3,4,5,6
Health-related quality of life (HRQOL)
Months 1,2 3,4,5,6
- +2 more secondary outcomes
Study Arms (2)
Hub Clinic MOUD with buprenorphine only (HC-MOUD Only)
ACTIVE COMPARATORParticipants 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.
Recovery Guiding / Better Together Medications for Opioid Use Disorder (BT-MOUD) procedures
EXPERIMENTALBetter 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
MOUD with buprenorphine provided in a hub buprenorphine clinic
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
You may qualify if:
- Be 16 years of age or older
- 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 \[Note that the "start" of a "current, new treatment episode" of MOUD with buprenorphine is defined as the date MOUD with buprenorphine was prescribed by a hub clinic provider.\]
- Is willing and able to provide written informed consent
- Is willing and able to provide reliable locator information to facilitate contacting the participant for research follow-up assessments
- Speaks English well enough to be able to comprehend the study procedures and complete the assessments
You may not qualify if:
- Plans to move out of the area or anticipate not being able to remain in the study for 6 months
- 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
- Has been previously enrolled in CTN-0144 or CTN-0088 or is currently enrolled in another clinical trial for treatment of OUD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Emmes Company, LLCcollaborator
- University of Marylandcollaborator
- Howard Universitylead
- University of Illinois at Chicagocollaborator
- University of Miamicollaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (4)
Howard University
Washington D.C., District of Columbia, 20059, United States
University of Miami
Miami, Florida, 33136, United States
University of Illinois- Chicago
Chicago, Illinois, 60608, United States
University of Maryland
Baltimore, Maryland, 21223, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard S Schottenfeld, MD
Howard University
- PRINCIPAL INVESTIGATOR
Viviana Horigian, MD, MHA
University of Miami
- PRINCIPAL INVESTIGATOR
Niranjan Karnik, MD, PhD
University of Illinois Chicago
- STUDY DIRECTOR
Denise M. Scott, PhD
Howard University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Chair, Department of Psychiatry
Study Record Dates
First Submitted
April 19, 2024
First Posted
May 16, 2024
Study Start
January 26, 2026
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
December 3, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Datasets for Clinical Trials Network Protocol -144 (CTN-0144) will be available when either (1) the primary outcome paper has been accepted for publication, (2) the data has been locked for more than 18 months, or (3) the grant concludes; whichever comes first. The datasets will remain accessible via NIDA Data Share contingent on NIDA's continued support of the archive. To date, NIDA Data Share has not deleted any deposited data.
- Access Criteria
- Access to the scientific data generated from CTN-0144 will be controlled via a registration agreement for data use on the NIDA Data Share Website.
This study will comply with the NIH Policy for Data Management and Sharing (Notice Number: NOT-OD-21-013) (https://grants.nih.gov/grants/policy/data\_sharing/data\_sharing\_guidance.htm) and for Helping to End Addiction Long-Term (HEAL) funded studies) the HEAL Public Access and Data Sharing Policy (https://www.nih.gov/research-training/medical-research-initiatives/heal initiative/research/heal public-access-data-sharing-policy)\]. For more details on data sharing please visit https://datashare.nida.nih.gov/.