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Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment.

StatusRecruiting
PhasePhase 4
Started2024-06-04
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Yale University

Amendment history

2026-09-09
Study Status, Arms and Interventions, Outcome Measures, Contacts/Locations v13
Primary endpoint(s) modified1 entry, revised
WasNumber of days of continuous treatment with study site clinician-prescribed methadone or buprenorphine, as randomized, during the 168 days post-randomization among RCT participants.
NowNumber of days of continuous treatment with site clinician-prescribed methadone or buprenorphine, as randomized, during the 168 days post-randomization among RCT participants.
Secondary endpoints12 to 17 entries
Number of self-reported continuous treatment days in any FDA-approved formulation of MOUD treatment (e.g., buprenorphine, methadone or naltrexone) during the 168 days post-randomization. Number of self-reported continuous treatment days in formal OUD treatment, according to American Society [...] levels of care 1-4, during the 168 days post-randomization. NumberTotal number of days prescribedreceiving any FDA-approved MOUD formulation during the 168 days post-randomization. NumberThe longest duration of continuous treatment episode with MOUD, as randomized, during the 168 days post randomization. Tot [...] [...]
Study sitescontacts updated at 1 of 6 sites
2026-04-29
Study Status, Study Description, Outcome Measures, Contacts/Locations v12
Study description+5 characters
[...] ith pharmacy administration and/or dispensing. An ancillary sub-extended study was added to this trial in January of 2026. A sub-set [...]
Study sitescontacts updated at 3 of 6 sites
2026-04-13
Study Status, Study Description, Outcome Measures, Contacts/Locations v11
Completion date2029-05→2028-12
Study description+241 characters
[...] ed methadone with pharmacy administration and/or dispensing. An ancillary sub-study was added to this trial in January of 2026. A sub-set of current participants that were receiving office based methadone as of day 168 of the parent study will continue to be followed for other pre-specified outcomes.
Study sitescontacts updated at 2 of 6 sites
2025-10-28
Study Status, Eligibility v10
Eligibility criteria-13 characters
[...] treatment services as determined by site clinician Be unable or unwilling to provide locator information including one or more contac [...]
2025-08-01
Study Status, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v9
Eligibility criteria-7 characters
[...] ermined by site clinician Be unable or unwilling to provide reliable locator information including 2one or more contacts in addition to themselves Be unwilling to [...]
Secondary endpointsdetails revised at 1 of 12 entries
Study sitesdetails revised at 4 of 6 sites
Show 8 earlier versions
2024-08-26
Study Status, Contacts/Locations v8
Study sitesdetails revised at 2 of 6 sites
2024-07-31
Study Status, Contacts/Locations v7
Study sitesdetails revised at 1 of 6 sites
2024-07-08
Study Status, Contacts/Locations v6
Study sitescontacts updated at 1 of 6 sites
2024-06-13
Study Status, Contacts/Locations v5
Study sitesdetails revised at 1 of 6 sites
2024-06-12
Study Status v4
Start dateestimated 2024-05→confirmed 2024-06-04
2024-05-29
Study Status, Contacts/Locations v3
Study sitescontacts updated at 3 of 6 sites
2024-05-21
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 6 of 6 sites
2024-05-10
Study Status, Contacts/Locations v1
Study sites0→6
2024-03-14
Original filing
Yale University
487 trials monitored
See 35 trials at risk
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.
Trial Details
NCT Number NCT06323824
Lead Sponsor Yale University
Collaborators: National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA), The Emmes Company, LLC, University of California, San Francisco, Boston Medical Center (BMC), Hennepin Healthcare Research Institute, Alameda Health System, Marshall Health, Kaiser Permanente
Conditions Opioid Use Disorder
Enrollment 600 participants
Start Date 2024-06-04
Primary Completion 2028-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-14