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New study could speed up methadone restart for opioid users

NCT ID NCT07546396

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a 'rapid restart' approach for people with opioid use disorder who have missed 4-8 doses of methadone. Instead of slowly increasing the dose again, participants may return to their previous stable dose right away. The goal is to see if this method is acceptable and safe, with 25 adults taking part over a 7-day follow-up.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Methadone
What this could lead to
If successful, this could make it easier and faster for people with opioid use disorder to get back on methadone treatment after missing doses, potentially reducing relapse and overdose risk.
What could go wrong
This is a very small early study (25 people) focused on feasibility, not effectiveness. The rapid restart approach may not be safe or acceptable for everyone, and results may not apply to broader populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 19 years or older 2. Opioid use disorder (OUD) of any severity by DSM-5 TR Clinical Diagnostic criteria \[American Psychiatric Association, 2022\] 3. Previously 'stable' on methadone as per the below definitions: 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. 2. 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. 4. Missed 4-8 doses of methadone in a row leading up to intake assessment. 5. 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. 6. Self-reported increased use of fentanyl since stopping methadone. 7. No significant change in opiate withdrawal symptoms as compared to when on methadone, based on self-report and examination. 8. Urine drug test (UDT) positive for fentanyl at screening or within 24 hours prior to re-initiating methadone. 9. Participant wishes to continue methadone maintenance treatment. 10. If applicable the participant must be willing to complete a urine pregnancy test to ensure they are not currently pregnant. 11. Participants will require a baseline ECG that demonstrates a QTc \< 500ms. 12. For participants from VGH study site specifically: 1. must be admitted to either psychiatry or CTU, ideally with planned admission of at least 3 days. 2. 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). 3. 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. 13. The participants must be willing and able to provide written informed consent for study participation. Exclusion Criteria: 1. COWS score of 8 or more at the time of clinician assessment 2. Self-reported Opioid overdose or naloxone administration since methadone discontinuation or during the 5 days prior to methadone discontinuation 3. Self-reported New cardiac disease diagnosis since methadone discontinuation 4. Self-reported Intolerable side effects reported when taking methadone 5. Individuals who are pregnant (urine pregnancy test) or breast-feeding (self-reported) 6. Use of buprenorphine-naloxone (Suboxone®, Sublocade®, Butrans ®) within the previous 3 days (self-reported) 7. Participants with a QTc interval \>500 msec on the screening ECG

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1N1, Canada

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