Slow-Release Oral Morphine for the Treatment of Opioid Use Disorder (pRESTO)
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|ClinicalTrials.gov Identifier: NCT03948464|
Recruitment Status : Suspended (Temporarily suspended due to COVID-19 precautions)
First Posted : May 14, 2019
Last Update Posted : September 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Opioid-Related Disorders Opiate Substitution Treatment Morphine Methadone Fentanyl||Drug: Slow release oral morphine (SROM) Drug: Methadone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||198 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||1:1 randomization|
|Masking:||None (Open Label)|
|Official Title:||Repurposing Slow-Release Oral Morphine as a New Oral Alternative for the Treatment of Opioid Use Disorder|
|Actual Study Start Date :||December 6, 2019|
|Estimated Primary Completion Date :||December 6, 2021|
|Estimated Study Completion Date :||January 31, 2024|
Experimental: Slow release oral morphine (SROM)
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)
Slow release oral morphine is an opioid agonist. Slow release oral morphine will be administered via daily witnessed ingestion at designated community pharmacies.
Other Name: Kadian
Active Comparator: Methadone
Daily witnessed ingestion of methadone for 24 weeks as per provincial and national guidelines for opioid use disorder.
Methadone is an opioid agonist. Methadone will be administered via daily witnessed ingestion at designated community pharmacies.
Other Name: Methadose/ Metadol D/Compounded methadone
- Opioid Use [ Time Frame: 24 weeks ]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
- Treatment Retention [ Time Frame: 24 weeks ]Treatment retention will be measured by the proportion of participants on the assigned opioid agonist treatment (OAT) at the end of the study, defined as having both a) an active prescription for the assigned OAT at week 24, and b) a positive urine drug screen result for the assigned OAT at week 24.
- Adverse Events Related to Study Medications [ Time Frame: 24 weeks ]The safety of each study medication will be evaluated by monitoring and gathering information on adverse events (AE) and serious adverse events (SAE), including overdoses, from the time of treatment initiation until the Safety Follow-up Visit. AEs and SAEs will be summarized by MedDRA (Medical Dictionary for Regulatory Activities) System Organ Class and Preferred Term, and the frequency and nature of AEs and SAEs will be compared across treatment arms.
- Number of Overdose Events [ Time Frame: 24 weeks ]Non-fatal overdoses since the previous visit will be assessed at baseline and every 12 weeks during the 24-week active treatment period, through a combination of self-report and participant's medical record. Data on fatal overdoses will be captured using vital statistics, and supplemented with information from contacts.
- Treatment Satisfaction: Medication Satisfaction Questionnaire (MSQ) [ Time Frame: 24 weeks ]Participant satisfaction with the assigned treatment will be assessed through administration of the Medication Satisfaction Questionnaire (MSQ) at weeks 4, 12 and 24 of the study. This single-item patient-completed questionnaire evaluates participant's satisfaction with treatment medication on a 7-point Likert scale ranging from "extremely dissatisfied" to "extremely satisfied."
- Psychological Functioning [ Time Frame: 24 weeks ]Psychological functioning will be measured by the "PROMIS (Patient-Reported Outcomes Measurement Information System) Emotional Distress -Anxiety-Short Form" and the "PROMIS Emotional Distress-Depression-Short Form" measures for anxiety and depression. These instruments will be administered at baseline, as well as at weeks 4, 12 and 24. These measures sum the frequency with which a participant experiences symptoms of depression and anxiety.
- Changes in Drug-Related Problems [ Time Frame: 24 weeks ]The Addiction Severity Index (ASI) Self-Report Form will be used to assess changes in drug-related problems between baseline and week 24. The ASI has 34 questions. The answer value of each question is divided by its maximum answer value and the total number of questions, and the individual results are then summed to create a composite value.
- Changes in Quality of Life: EQ-5D-5L [ Time Frame: 24 weeks ]Changes in health-related quality of life (HRQoL) between baseline and the end of treatment will be measured by the EuroQol "EQ-5D-5L" tool. The EQ-5D-5L will be administered at baseline and every 4 weeks during the 24-week active treatment period. The EQ-5D-5L includes a 5-level descriptive system and a visual analogue scale.The descriptive system has five categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which will be rated on a scale of 1 to 5 with 1 being the least severe and 5 being the most severe. The visual analogue scale is a vertical scale from 0 to 100, with 0 labelled "the worst health you can imagine" and 100 labelled "the best health you can imagine."
- Opioid Craving [ Time Frame: 24 weeks ]Opioid cravings over time will be measured using a 100 mm visual analog scale (VAS). The VAS will be administered at baseline, week 2, week 4, and every 4 weeks for the remainder of the 24-week active treatment period. The VAS is a horizontal scale with 11 lines labeled from left to right with the numbers "0" to "10", and word anchors at each end representing the extremes, where "0=no craving" and "100 mm=most intense craving".
- Other Substance Use [ Time Frame: 24 weeks ]Use of other substances will be measured using the Timeline Follow-Back (TLFB) instrument, which will be administered at baseline and every study visit thereafter.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948464
|Canada, British Columbia|
|BCCSU Cordova Office|
|Vancouver, British Columbia, Canada, V6A 4H3|
|Principal Investigator:||M. Eugenia Socias, MD, MSc||BC Centre on Substance Use|