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Methadone Rapid Restart

NCT07546396 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-04-22

No results posted yet for this study

Summary

The usual treatment for opioid use disorder (OUD) is opioid agonist therapy (OAT) with either methadone or buprenorphine. These treatments are well-established, reduce the risk of fatal overdoses, and are considered the standard approach. However, current methadone guidelines were developed when most people were using heroin, which is far less potent than today's unregulated/illicit fentanyl supply. As a result, people who use fentanyl often need higher doses to feel stable. Because methadone must be started at low doses and increased slowly, it can take weeks before someone reaches an effective dose. This process becomes even longer when doses are missed, since treatment often needs to be restarted at a lower level.

The Methadone Rapid Restart is a newer strategy designed to take ongoing fentanyl use into account. Early clinical experience and modelling suggest that many people who use fentanyl have high opioid tolerance and may be able to return to their previous stable methadone dose even after several missed days, without added safety risk. This approach has shown promise in small clinical settings, but it is not yet known whether it provides better outcomes than the standard methadone titration used today. This study will be testing whether this protocol to help rapidly restart people on Methadone is acceptable for patients and use the learning to guide a subsequent larger clinical trial.

Conditions

Interventions

DRUG

Methadone

Participants who meet study inclusion criteria and have no exclusion criteria, who have missed 4-8 doses of methadone will, be administered methadone according to the stratification below and will continue the same dose for the 7 day follow up. * Arm 1: Previous maintenance treatment with methadone for opioid use disorder at a stable dose for at least 5 consecutive days prior to discontinuing, with allowance for a maximum of 1 missed dose within that 5-day period. These participants will be re-initiated on 100% of their most recent methadone dose. * Arm 2: Participant was being titrated on methadone prior to discontinuation such that they were on their most recent dosage for less than 5 days but received at least 5 consecutive days of methadone between the prior two dosages (with a maximum of 1 missed dose in that period) be. These participants will be restarted on the lower of their two most recent dosages.

Sponsors & Collaborators

  • Pouya Azar

    lead OTHER

Principal Investigators

  • Pouya Azar · Department of Psychiatry, Faculty of Medicine, University of British Columbia and Vancouver General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07546396 on ClinicalTrials.gov