Trial Summary
What is the purpose of this trial?A multisite effectiveness-implementation study will be conducted in three sites to evaluate interventions to improve engagement and retention in MOUD with buprenorphine treatment of Black persons with OUD. 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
This trial is for African American individuals struggling with opioid use disorder (OUD). Participants should be interested in receiving treatment involving medication-assisted therapy with buprenorphine. Details on specific inclusion and exclusion criteria are not provided, but typically these would relate to health status, age, and other factors relevant to the study.Inclusion Criteria
Willing and able to provide informed consent, and when applicable, signed assent (consent process)
I am considering and suitable for medication-assisted treatment with buprenorphine.
Self-identify race as Black (or African American, African, or Afro-Caribbean) (self report)
+4 more
Exclusion Criteria
I am unable to understand and give consent due to cognitive or developmental issues.
Have a psychiatric, cognitive, or medical condition which would make participation inappropriate or contraindicated, as assessed by the hub buprenorphine clinic provider
Plan to move out of the area or do not anticipate being able to remain in the study for 6 months
+3 more
Participant Groups
The study compares two approaches: standard care using buprenorphine at a clinic (HC-MOUD Only) versus a community-based model offering telemedicine and coaching support (BT-MOUD). The goal is to see which method keeps patients in treatment longer over a period of 24 weeks after they start.
2Treatment groups
Experimental Treatment
Active Control
Group I: Recovery Guiding / Better Together Medications for Opioid Use Disorder (BT-MOUD) proceduresExperimental Treatment1 Intervention
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 II: Hub Clinic MOUD with buprenorphine only (HC-MOUD Only)Active Control1 Intervention
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MiamiMiami, FL
Howard UniversityWashington, United States
University of FloridaMiami, FL
University of Illinois- ChicagoChicago, IL
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Who Is Running the Clinical Trial?
Howard UniversityLead Sponsor
The Emmes Company, LLCIndustry Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
University of Illinois at ChicagoCollaborator
University of MiamiCollaborator