Trials
Search / Trial NCT06416020

Integrating MOUD in African American Community Settings (Better Together)

Launched by HOWARD UNIVERSITY · May 14, 2024

Trial Information

Current as of February 19, 2025

Not yet recruiting

Keywords

Moud African American Oud Buprenorphine

ClinConnect Summary

This multi-site hybrid Type 1 effectiveness-implementation study conducted in Washington, District of Columbia (DC), Chicago, and Miami-Dade County will evaluate: 1) the effectiveness of providing MOUD with buprenorphine onsite (via telemedicine from a hub buprenorphine clinic) combined with Recovery Guiding in nonmedical community-based settings (the Better Together Integrated Collaborative Community MOUD care model - BT-MOUD) compared to standard-of-care MOUD with buprenorphine provided in the hub buprenorphine clinic only (HC-MOUD Only) and 2) BT-MOUD implementation barriers and facilita...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Be 16 years of age or older, as documented by self-report and verified by staff at the hub buprenorphine clinic.
  • 2. Self-identify race as Black (or African American, African, or Afro-Caribbean) (self report)
  • 3. Meets the Diagnostic Statistical Manual (DSM) -5 diagnostic criteria for current moderate or severe OUD, based on clinical evaluation by a hub clinic buprenorphine provider and documented in the hub clinic medical record.
  • 4. Be seeking, interested in receiving, and suitable for MOUD with buprenorphine, based on clinical evaluation by a hub clinic buprenorphine provider and documented in the hub clinic medical record.
  • 5. Have not received MOUD in the 30 days prior to enrolling in MOUD in the hub buprenorphine clinic (based on Prescription Drug Monitoring Program \[PDMP\] and self-report)
  • 6. Willing and able to provide informed consent, and when applicable, signed assent (consent process)
  • 7. Speak English well enough to be able to comprehend the study procedures and complete the assessments.
  • Exclusion Criteria:
  • 1. Have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent/assent.
  • 2. Have a psychiatric, cognitive, or medical condition which would make participation inappropriate or contraindicated, as assessed by the hub buprenorphine clinic provider.
  • 3. Plan to move out of the area or do not anticipate being able to remain in the study for 6 months.
  • 4. Are unable or unwilling to provide reliable locator information.
  • 5. Are 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.
  • 6. They have previously enrolled in Clinical Trials Network (CTN) Protocol-0144 or are currently enrolled in another clinical trial for treatment of OUD.

Trial Officials

Richard S Schottenfeld, MD

Principal Investigator

Howard University

Jose Szapocznik, PhD

Principal Investigator

University of Miami

Niranjan Karnik, MD, PhD

Principal Investigator

University of Illinois Chicago

Denise M. Scott, PhD

Study Director

Howard University

About Howard University

Howard University is a distinguished institution committed to advancing health equity and innovative research through its clinical trials. As a prominent educational and research entity, Howard University leverages its robust network of faculty expertise, state-of-the-art facilities, and diverse patient population to conduct high-quality clinical studies. The university aims to address pressing health issues, enhance treatment modalities, and contribute to the broader scientific community while fostering the development of future leaders in healthcare and research. Through its rigorous and ethical approach to clinical trials, Howard University plays a vital role in translating research findings into meaningful healthcare advancements.

Locations

Washington, District Of Columbia, United States

Miami, Florida, United States

Chicago, Illinois, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0