NCT03948464

Slow-Release Oral Morphine for the Treatment of Opioid Use Disorder

Repurposing Slow-Release Oral Morphine as a New Oral Alternative for the Treatment of Opioid Use Disorder

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: M. Eugenia Socias · Academic / Other
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a non-inferiority randomized clinical trial that will compare slow release oral morphine vs methadone as a second line oral treatment for opioid use disorder.

Detailed description

Slow-release oral morphine (SROM) has emerged as a promising yet understudied form of oral treatment for opioid use disorder (OUD), with preliminary studies suggesting similar efficacy rates as methadone with respect to promoting abstinence, and with better improvements in a number of patient-reported outcomes, including tolerability, treatment satisfaction, mental symptoms, and craving. The proposed study is an open-label, non-inferiority, randomized controlled trial evaluating the relative effectiveness, safety and acceptability of SROM vs. methadone for the treatment of OUD in outpatient clinical settings. Participants will be randomized 1:1 to SROM or methadone for 24 weeks. Data linkages performed three years after randomization will evaluate long term health outcomes. This study aims to provide evidence to optimize care for individuals with OUD, and potentially increase access to additional form of evidence-based oral treatment.

Conditions

• Opioid-Related Disorders
• Opiate Substitution Treatment
• Morphine
• Methadone
• Fentanyl

Interventions

Type	Name	Description
DRUG	Slow release oral morphine (SROM)	Slow release oral morphine is an opioid agonist. Slow release oral morphine will be administered via daily witnessed ingestion at designated community pharmacies.
DRUG	Methadone	Methadone is an opioid agonist. Methadone will be administered via daily witnessed ingestion at designated community pharmacies.

Timeline

• Start date: 2019-12-06
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2019-05-14
• Last updated: 2022-02-10

Locations

1 site across 1 country: Canada