Integrating MOUD in Nonmedical Community Settings (Better Together)
ConditionOpioid Use Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorHoward University
About this trial
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
Qualifiers
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
Disqualifiers
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.]
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
Trial design
Treatments tested in this trial
- HC-MOUD Only
- BT-MOUD with Buprenorphine
Treatment groups
400 Participants
are divided into 2 treatment groupsSponsors and collaborators
Howard University
Lead sponsor
University of Illinois at Chicago
Collaborator
University of Miami
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
The Emmes Company, LLC
Collaborator
University of Maryland
Collaborator
Source ClinicalTrials.gov