NCT06416020 Integrating MOUD in Nonmedical Community Settings (Better Together)
| NCT ID | NCT06416020 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Howard University |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2026-04-15 |
| Primary Completion | 2029-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2026-04-15 with a primary completion date of 2029-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 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
Contact & Investigator
Richard S Schottenfeld, MD
PRINCIPAL INVESTIGATOR
Howard University
Frequently Asked Questions
Who can join the NCT06416020 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06416020 currently recruiting?
Yes, NCT06416020 is actively recruiting participants. Contact the research team at richard.schottenfeld@howard.edu for enrollment information.
Where is the NCT06416020 trial being conducted?
This trial is being conducted at Washington D.C., United States, Miami, United States, Chicago, United States, Baltimore, United States.
Who is sponsoring the NCT06416020 clinical trial?
NCT06416020 is sponsored by Howard University. The principal investigator is Richard S Schottenfeld, MD at Howard University. The trial plans to enroll 400 participants.