Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Dis… (NCT06323824) | Clinical Trial Compass
RecruitingPhase 4
Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment.
United States600 participantsStarted 2024-06-04
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion Criteria
* 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
Exclusion Criteria
* 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).
* 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 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
* Be unable to provide locator information including one or more contacts in addition to themselves
* 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
* Cur…
What they're measuring
1
Number of days of continuous treatment with study site clinician-prescribed methadone or buprenorphine, as randomized, during the 168 days post-randomization among RCT participants.