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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
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
2002
Completed Phase 4
~4460

Find a Location

Who is running the clinical trial?

Kaiser PermanenteOTHER
552 Previous Clinical Trials
27,701,657 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,807 Previous Clinical Trials
8,152,990 Total Patients Enrolled
University of California, San FranciscoOTHER
2,576 Previous Clinical Trials
15,176,479 Total Patients Enrolled
~400 spots leftby Dec 2028
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