Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment.
NCT ID: NCT06323824
Last Updated: 2025-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
600 participants
INTERVENTIONAL
2024-06-04
2029-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Office-based methadone where the clinician prescribes methadone and oral methadone is administered and/or dispensed at a pharmacy. Providers and Randomized Control Trial (RCT) participants will have flexibility to use behavioral and pharmacological services as clinically indicated.
Office-based buprenorphine (BUP) where the clinician prescribes BUP formulations that are dispensed at a pharmacy or administered in the office (e.g., extended-release formulations). Providers and RCT participants will have flexibility to use behavioral and pharmacological services as clinically indicated.
TREATMENT
NONE
Study Groups
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Office-based methadone
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).
Methadone
Drug: Methadone
Possible formulations:
10 and 50 mg tablets
Office-based buprenorphine (BUP)
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).
Buprenorphine (BUP)
Drug: Buprenorphine (BUP)
Possible formulations:
A. Buprenorphine 225 mcg to 24 mg 225 mcg to 32 mg per day
B. Buprenorphine (Extended release) 300 mg q 28 days (Sublocade) 100 mg q 28 days (Sublocade) 8 mg q 7 days (Brixadi) 16 mg q 7 days (Brixadi) 24 mg q 7 days (Brixadi) 32 mg q 7 days (Brixadi) 64 mg q 7 28 days (Brixadi) 96 mg q 7 28 days (Brixadi) 128 mg q 7 28 days (Brixadi)
Interventions
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Methadone
Drug: Methadone
Possible formulations:
10 and 50 mg tablets
Buprenorphine (BUP)
Drug: Buprenorphine (BUP)
Possible formulations:
A. Buprenorphine 225 mcg to 24 mg 225 mcg to 32 mg per day
B. Buprenorphine (Extended release) 300 mg q 28 days (Sublocade) 100 mg q 28 days (Sublocade) 8 mg q 7 days (Brixadi) 16 mg q 7 days (Brixadi) 24 mg q 7 days (Brixadi) 32 mg q 7 days (Brixadi) 64 mg q 7 28 days (Brixadi) 96 mg q 7 28 days (Brixadi) 128 mg q 7 28 days (Brixadi)
Eligibility Criteria
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Inclusion Criteria
* Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for OUD;
* Are initiating a new MOUD treatment episode
Exclusion Criteria
* 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
* 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.
18 Years
99 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute on Drug Abuse (NIDA)
NIH
The Emmes Company, LLC
INDUSTRY
University of California, San Francisco
OTHER
Boston Medical Center (BMC)
UNKNOWN
Hennepin Healthcare Research Institute
OTHER
Alameda Health System
OTHER
Marshall Health
UNKNOWN
Kaiser Permanente
OTHER
Yale University
OTHER
Responsible Party
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Principal Investigators
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David Fiellin, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Highland Hospital Bridge Clinic at Alameda Health System
Oakland, California, United States
Outpatient Buprenorphine Induction Clinic, University of California, San Francisco
San Francisco, California, United States
Rapid Start Clinic, Kaiser Permanente Colorado
Denver, Colorado, United States
Officed Based Addiction Treatment Program, Boston Medical Center
Boston, Massachusetts, United States
Hennepin Healthcare Addiction Medicine
Minneapolis, Minnesota, United States
Marshall University Division of Addiction Sciences P.R.O.A.C.T
Huntington, West Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CTN-0131
Identifier Type: OTHER
Identifier Source: secondary_id
2000033271
Identifier Type: -
Identifier Source: org_study_id
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