Methadone Rapid Restart

Sponsor
Pouya Azar
Study ID
NCT07546396
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Methadone — DRUG
    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.

Study Details

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 Dates

First listed
Apr 22, 2026
Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Methadone rapid restart for participants on methadone maintenance treatment
    Participants who have missed 4-8 doses of methadone, but were on 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.
  • Experimental: Methadone rapid restart for participants being titrated on methadone
    Participants who have missed 4-8 doses of methadone, but were 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.

Primary Outcome Measure

Enrollment rate [ Time Frame: Enrollment ]

Central Contacts

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