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

NCT03948464 | Terminated Phase 3 DMC

• 1 other identifier: BCCSU-002
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

slow-release oral morphine; methadone; opioid use disorder; fentanyl

Outcome Measures

Primary Outcomes (1)

• Opioid Use

  This will be measured by the overall proportion of opioid-free urine drug screens during the 24 weeks of active treatment (excluding the assigned therapy and it's metabolites), with missing samples defined as being positive for opioids

  24 weeks

Secondary Outcomes (9)

• Treatment Retention

  24 weeks

• Adverse Events Related to Study Medications

  24 weeks

• Number of Overdose Events

  24 weeks

• Treatment Satisfaction: Medication Satisfaction Questionnaire (MSQ)

  24 weeks

• Psychological Functioning

  24 weeks

Study Arms (2)

Slow release oral morphine (SROM)

EXPERIMENTAL

Daily witnessed ingestion of SROM (24-hour formulation) for 24 weeks as per provincial and national guidelines for opioid use disorder.

Drug: Slow release oral morphine (SROM)

Methadone

ACTIVE COMPARATOR

Daily witnessed ingestion of methadone for 24 weeks as per provincial and national guidelines for opioid use disorder.

Drug: Methadone

Interventions

Slow release oral morphine (SROM) DRUG

Slow release oral morphine is an opioid agonist. Slow release oral morphine will be administered via daily witnessed ingestion at designated community pharmacies.

Also known as: Kadian

Slow release oral morphine (SROM)

Methadone DRUG

Methadone is an opioid agonist. Methadone will be administered via daily witnessed ingestion at designated community pharmacies.

Also known as: Methadose/ Metadol D/Compounded methadone

Methadone

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all the following criteria to be eligible for the study:
• Be between 19 and 65 years of age, inclusively;
• Be diagnosed with opioid use disorder requiring opioid agonist treatment (OAT), as per DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) criteria and the discretion of the study physician;
• Be interested in receiving OAT;
• Be willing and eligible to be randomized to slow release oral morphine (SROM) or methadone-based OAT as per British Columbia guidelines;
• If female:
• Be of non-childbearing potential, defined as (i) postmenopausal (12 months of spontaneous amenorrhea and over 45 years of age); or (ii) documented surgical sterilization (i.e., tubal ligation, hysterectomy, or bilateral oophorectomy); or
• If of childbearing potential, be willing to use an acceptable method of contraception throughout the study and have a negative pregnancy test at screening;
• Be able to provide written informed consent;
• Be willing to comply with study procedures;
• Be able to communicate in English;

You may not qualify if:

• Participants will be excluded from the study if any of the following criteria are met:
• Any disabling, severe, or unstable medical or psychiatric condition that, in the opinion of the study physician, precludes safe participation in the study or the ability to provide fully informed consent, as assessed by medical and psychiatric history, physical examination, vital signs, and/or laboratory tests. These may include but are not limited to: significant respiratory depression, severe respiratory compromise or obstructive disease, severe respiratory distress, acute or severe bronchial asthma, known or suspected paralytic ileus;
• Any severe or unstable co-morbid substance use disorder (e.g., delirium tremens, acute alcohol intoxication) that, in the opinion of the study physician, precludes safe participation in the study;
• Maintenance on buprenorphine at doses of ≥4 mg in the 5 days prior to screening and stable in the opinion of the study physician;
• Maintenance on methadone at doses of ≥60 mg in the 5 days prior to screening and stable in the opinion of the study physician;
• Maintenance on slow release oral morphine at doses of ≥250 mg in the 5 days prior to screening and stable in the opinion of the study physician;
• Pregnant, breastfeeding, or planning to become pregnant during the study period;
• History of a serious adverse drug reaction, hypersensitivity reaction, or allergy to methadone or SROM;
• Use of an investigational drug in the 30 days prior to screening;
• Pending legal action or other reasons that might prevent completion of the study;
• Current or anticipated need for treatment with any medication that may interact with methadone or SROM (e.g., benzodiazepines, monoamine oxidase inhibitors \[MAOIs\] pRESTO Protocol Version 3.0, 08 October 2019 Page 21 of 66 used currently or within the past 14 days) and that, in the opinion of the study physician, would be deemed unsafe or could prevent study completion.

Sponsors & Collaborators

• M. Eugenia Socias: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Vancouver Foundation: collaborator
• Mayne Pharma International Pty Ltd: collaborator

Study Sites (1)

BCCSU Cordova Office

Vancouver, British Columbia, V6A 4H3, Canada

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Morphine; Methadone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Ketones; Organic Chemicals

Study Officials

• M. Eugenia Socias, MD, MSc

  BC Centre on Substance Use

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Scientist

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 14, 2019
• Study Start: December 6, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: February 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)