Phase
Condition
Opioid Use Disorder
Stimulant Use Disorder
Treatment
Buprenorphine (BUP)
Methadone
Clinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 or unwilling to provide reliable locator information including 2 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
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.
Study Design
Study Description
Connect with a study center
Highland Hospital Bridge Clinic at Alameda Health System
Oakland, California 94602
United StatesActive - Recruiting
Outpatient Buprenorphine Induction Clinic, University of California, San Francisco
San Francisco, California 94103
United StatesActive - Recruiting
Rapid Start Clinic, Kaiser Permanente Colorado
Denver, Colorado 80205
United StatesActive - Recruiting
Officed Based Addiction Treatment Program, Boston Medical Center
Boston, Massachusetts 02118
United StatesActive - Recruiting
Hennepin Healthcare Addiction Medicine
Minneapolis, Minnesota 55415
United StatesActive - Recruiting
Marshall University Division of Addiction Sciences P.R.O.A.C.T
Huntington, West Virginia 25703
United StatesSite Not Available
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