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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 168

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

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