CTN-0131: Office-Based Methadone versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder (MOUD)– A Pragmatic Hybrid Effectiveness/Implementation Trial
David Fiellin, MD
Lead Investigator
Yale University School of Medicine
david.fiellin@yale.edu
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.
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