Buprenorphine Treatment for Opioid Use Disorder
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, you must not have received medication for opioid use disorder (MOUD) in the 30 days before enrolling.
What data supports the effectiveness of the drug Buprenorphine for treating opioid use disorder?
Is buprenorphine safe for humans?
Research shows that buprenorphine, used in a patch form for pain management, has been studied for safety in various conditions, including chronic pain and opioid use disorder. It is generally considered safe for humans, but like any medication, it may have side effects, and its use should be monitored by a healthcare professional.16789
How is the drug Buprenorphine Treatment for Opioid Use Disorder different from other treatments?
Buprenorphine Treatment for Opioid Use Disorder is unique because it can be administered as a sustained release formulation, which helps prevent misuse and nonadherence that can occur with daily oral forms. This approach may improve treatment retention and reduce the harms associated with opioid use disorder.15101112
Research Team
Niranjan Karnik, MD, PhD
Principal Investigator
University of Illinois Chicago
Richard S Schottenfeld, MD
Principal Investigator
Howard University
Viviana Horigian, MD, MHA
Principal Investigator
University of Miami
Denise M. Scott, PhD
Principal Investigator
Howard University
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive MOUD with buprenorphine, either through the BT-MOUD model or HC-MOUD Only, for retention in treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- BT-MOUD with Buprenorphine
- HC-MOUD Only
Find a Clinic Near You
Who Is Running the Clinical Trial?
Howard University
Lead Sponsor
The Emmes Company, LLC
Industry Sponsor
Peter Ronco
The Emmes Company, LLC
Chief Executive Officer since 2023
BSc from Nottingham University
Dr. Joe Sliman
The Emmes Company, LLC
Chief Medical Officer since 2020
MD from Uniformed Services University of the Health Sciences, MPH from Johns Hopkins University, BSc in Molecular and Cell Biology from Pennsylvania State University
National Institute on Drug Abuse (NIDA)
Collaborator
University of Illinois at Chicago
Collaborator
University of Miami
Collaborator