Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment - A Pragmatic Hybrid Effectiveness/Implementation Trial
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The purpose of this clinical trial is to compare the effectiveness of office-based methadone with pharmacy administration and/or dispensing to office-based buprenorphine for the treatment of opioid use disorder. This study will also examine factors influencing the implementation of office-based methadone.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• 18 years of age or older;
• Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for OUD;
• Are initiating a new MOUD treatment episode
Locations
United States
California
Highland Hospital Bridge Clinic at Alameda Health System
RECRUITING
Oakland
Outpatient Buprenorphine Induction Clinic, University of California, San Francisco
RECRUITING
San Francisco
Colorado
Rapid Start Clinic, Kaiser Permanente Colorado
RECRUITING
Denver
Massachusetts
Officed Based Addiction Treatment Program, Boston Medical Center
RECRUITING
Boston
Minnesota
Hennepin Healthcare Addiction Medicine
RECRUITING
Minneapolis
West Virginia
Marshall University Division of Addiction Sciences P.R.O.A.C.T
RECRUITING
Huntington
Contact Information
Primary
Jessica Research Associate
j.mckenzie@yale.edu
203-785-6821
Backup
Melissa Gordon
melissa.gordon@yale.edu
203-937-3486
Time Frame
Start Date: 2024-06-04
Estimated Completion Date: 2029-05
Participants
Target number of participants: 600
Treatments
Experimental: Office-based methadone
Under special Drug Enforcement Administration (DEA) exception, Clinician prescribes methadone and oral methadone is administered and/or dispensed at a pharmacy which also has an exception to do so. All randomized controlled trial (RCT) participants are offered additional behavioral treatments (e.g., individual, group, telehealth, phone-based).
Active_comparator: Office-based buprenorphine (BUP)
Clinician prescribes BUP formulations that are dispensed at a pharmacy or administered in the office (e.g., extended-release formulations). All RCT participants are offered additional behavioral treatments (e.g., individual, group, telehealth, phone-based).
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA), The Emmes Company, LLC, Hennepin Healthcare Research Institute, Boston Medical Center (BMC), National Institutes of Health (NIH), Marshall Health, University of California, San Francisco, Kaiser Permanente, Alameda Health System
Leads: Yale University