Better Together: integrating buprenorphine care in community settings

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This hybrid Type 1 effectiveness-implementation study takes place in DC, Chicago, Miami, and Baltimore to compare two approaches for buprenorphine treatment: BT-MOUD, which uses telemedicine from a hub clinic plus on-site Recovery Guiding at community sites, and HC-MOUD Only, which provides MOUD at the hub clinic. A Peer Outreach Specialist supports outreach and follow-up. The study will assess patient engagement, retention in care, adherence, and the feasibility of implementing the BT-MOUD model in nonmedical settings.

Why it matters

Who can join: the full rules

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

Where it's running

• Howard University
  Washington D.C., District of Columbia, United States Recruiting
• University of Miami
  Miami, Florida, United States Recruiting
• University of Illinois- Chicago
  Chicago, Illinois, United States Recruiting
• University of Maryland
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Richard S Schottenfeld, MD — Howard University
• Study coordinator: Richard S Schottenfeld, MD
• Email: richard.schottenfeld@howard.edu
• Phone: 202-865-6615

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.