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Opioid Replacement Therapy

Methadone vs Buprenorphine for Opioid Use Disorder

Phase 4
Recruiting
Led By David Fiellin, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 168
Awards & highlights

Summary

This trial aims to compare how well methadone given in a doctor's office works compared to buprenorphine for treating opioid addiction. It will also look at what factors affect how well meth

Who is the study for?
This trial is for adults over 18 who meet the criteria for Opioid Use Disorder (OUD) according to the DSM-5 and are starting a new medication treatment. Specific details on who can't join were not provided.
What is being tested?
The study compares two treatments for opioid addiction: methadone given at doctors' offices versus buprenorphine (BUP). It also looks into how well office-based methadone programs work.
What are the potential side effects?
Methadone may cause drowsiness, constipation, or lightheadedness. Buprenorphine can lead to similar effects like nausea, headaches, or withdrawal symptoms if stopped suddenly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 168
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 168 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Secondary outcome measures
Number of days of self-reported non-prescribed benzodiazepine use per month.
Number of days of self-reported non-prescribed opioid use per month.
Number of days of self-reported non-prescribed stimulant use per month.
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Office-based methadoneExperimental Treatment1 Intervention
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).
Group II: Office-based buprenorphine (BUP)Active Control1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methadone
2005
Completed Phase 4
~2930

Find a Location

Who is running the clinical trial?

Kaiser PermanenteOTHER
551 Previous Clinical Trials
27,690,360 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,132,913 Total Patients Enrolled
University of California, San FranciscoOTHER
2,551 Previous Clinical Trials
15,257,286 Total Patients Enrolled
~400 spots leftby Dec 2028
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