Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment.
Key facts
- Who runs it
- Yale University
- Where
- Boston, Denver, Huntington, Minneapolis, Oakland, and San Francisco, United StatesSee the 6 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 600 people, planned
- Started
- 4 Jun 2024
- Expected to end
- Dec 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Methadone
- Buprenorphine (BUP)
- Record updated
- 14 September 2026
Who can take part
- Age
- 18 years to 99 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- Have been prescribed (and ingested) or been administered more than 72 hours of MOUD in the 7 days prior to randomization as a "bridge" to the new OUD treatment episode. Such MOUD may include prescribed (and ingested) or administered medically managed withdrawal (aka detoxification)
- Be unwilling to follow study procedures (e.g., unwilling to receive treatment from site clinician, use the study pharmacy, unwilling to be randomized to BUP or methadone, or will be unavailable for the follow-up assessments) including allowing the researchers to access their record in the EMR and state's prescription drug monitoring program
- Have previously enrolled in CTN-0131
- Be actively suicidal or severely cognitively impaired (e.g., dementia, untreated psychosis) precluding informed consent as determined by site clinician
- Current severe comorbid substance use disorder requiring residential or inpatient treatment services as determined by site clinician
- Known contraindication to methadone or BUP
- Unwilling to pursue or continue pre-natal care or pregnancy counseling if determined pregnant by urine human chorionic gonadotropin (hCG) testing at the screening assessment
- Be unable to provide locator information including one or more contacts in addition to themselves
- Currently enrolled in another research study which will conflict with study procedures
- 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
- Unable to conduct research assessments in English as determined by Site PI or their designee
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Where in United States
- Officed Based Addiction Treatment Program, Boston Medical CenterBoston, United StatesContact: Emily OotTaking people
- Rapid Start Clinic, Kaiser Permanente ColoradoDenver, United StatesContact: Jennifer BarrowTaking people
- Marshall University Division of Addiction Sciences P.R.O.A.C.THuntington, United StatesContact: Brynn M TaylorTaking people
- Hennepin Healthcare Addiction MedicineMinneapolis, United StatesContact: Fiona GilesTaking people
- Highland Hospital Bridge Clinic at Alameda Health SystemOakland, United StatesContact: Jhoselyn PinedaTaking people
- Outpatient Buprenorphine Induction Clinic, University of California, San FranciscoSan Francisco, United StatesContact: Kristina TomaTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Office-based methadoneTreatment being tested
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).
Treatment: Methadone
- Office-based buprenorphine (BUP)Existing treatment, for comparison
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).
Treatment: Buprenorphine (BUP)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment - A Pragmatic Hybrid Effectiveness/Implementation Trial
- Fit questions
- Built from NCT06323824, who can take part
- Record updated
- 14 September 2026