Methadone Rapid Restart

Starting soon · Phase 4

Conditions studied: Opioid Use Disorder

In brief

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.

Key facts

Study ID

NCT07546396

Run by

Pouya Azar

People needed

25

Starts

2026-05-01

Expected to finish

2027-03-01

Last updated by the study team

2026-04-22

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 19 years or older
• Opioid use disorder (OUD) of any severity by DSM-5 TR Clinical Diagnostic criteria [American Psychiatric Association, 2022]
• Previously 'stable' on methadone as per the below definitions:
• 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.
• Participants who were being titrated on methadone for opioid use disorder prior to discontinuation. If participants were on the most recent dose for less than 5 days, they can be restarted on the prior dose providing they cumulatively received 5 consecutive doses (with a maximum of 1 missed dose in that period) between the two most recent dosages.
• Missed 4-8 doses of methadone in a row leading up to intake assessment.
• Participant able to provide baseline opiate use history as per opiate use screening questions in Appendix A. This must provide an estimate of opiate use prior to stopping methadone and change in use since stopping.
• Self-reported increased use of fentanyl since stopping methadone.
• No significant change in opiate withdrawal symptoms as compared to when on methadone, based on self-report and examination.
• Urine drug test (UDT) positive for fentanyl at screening or within 24 hours prior to re-initiating methadone.
• Participant wishes to continue methadone maintenance treatment.
• If applicable the participant must be willing to complete a urine pregnancy test to ensure they are not currently pregnant.
• Participants will require a baseline ECG that demonstrates a QTc < 500ms.
• For participants from VGH study site specifically:
• must be admitted to either psychiatry or CTU, ideally with planned admission of at least 3 days.
• must agree if discharged prior to the completion of the 7 day follow up period, to either return to VGH Diamond Centre for follow up assessments on Days 1/3/7 (+/-2 days).
• must have access to a functioning cell phone to allow for the study team to contact them in case of discharge prior to completion of study follow up period.
• The participants must be willing and able to provide written informed consent for study participation.

You may not qualify if…

• COWS score of 8 or more at the time of clinician assessment
• Self-reported Opioid overdose or naloxone administration since methadone discontinuation or during the 5 days prior to methadone discontinuation
• Self-reported New cardiac disease diagnosis since methadone discontinuation
• Self-reported Intolerable side effects reported when taking methadone
• Individuals who are pregnant (urine pregnancy test) or breast-feeding (self-reported)
• Use of buprenorphine-naloxone (Suboxone®, Sublocade®, Butrans ®) within the previous 3 days (self-reported)
• Participants with a QTc interval >500 msec on the screening ECG

Where it is running

• Vancouver General Hospital — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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