Methadone or Enhanced Buprenorphine to Address Retention Among Patients not Optimally Benefitting from Office-based Buprenorphine – a Hybrid Effectiveness/Implementation Trial

There is a need to address sub-optimal retention in office-based buprenorphine (BUP) and expand access to methadone outside of opioid treatment programs (OTP). Clinicians currently have 2 options for patients not optimally benefitting from office-based BUP. They can attempt to enhance BUP services or refer the patient to an OTP for methadone. We propose to evaluate a needed new option – office-based methadone prescribing (under special arrangements) with off-site methadone dispensing. Investigators propose to conduct hybrid effectiveness implementation trial to compare: 1) Office-based methadone where the current office-based BUP prescriber manages a switch to and continuation of methadone in partnership with a local methadone dispensing facility versus; 2) Enhanced BUP where the office-based BUP provider continues BUP treatment while providing enhanced behavioral treatment and/or implementing strategies to address adherence if indicated. Investigators will use mixed methods and an implementation science framework to identify implementation barriers and facilitators at the patient, provider and health-systems level for office-based methadone

CTN Protocol ID: 
CTN-0131
Status: 
Development

Principal Investigator(s)

David Fiellin, M.D.

Professor of Medicine and Public Health
Yale University School of Medicine

333 Cedar Street
P.O. Box 208056
New Haven, CT 06520
United States