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Compares treatment options for Opioid Use Disorder
Official title Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment.
ClinicalTrials.gov ID: NCT06323824
What this study is testing
What is Methadone?
Methadone is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for opioid use disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
- Be actively suicidal or severely cognitively impaired (e.g., dementia, untreated psychosis) precluding informed consent as determined by site...
- 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
See the full eligibility 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
- 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...
- 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 assigned by chance to BUP or methadone, or will be unavailable for the follow-up...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Oakland, California, United States
- San Francisco, California, United States
- Denver, Colorado, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Huntington, West Virginia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oakland, California, United States; San Francisco, California, United States; Denver, Colorado, United States; Boston, Massachusetts, United States; Minneapolis, Minnesota, United States; Huntington, West Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.