Real-World Evidence in Patient-Reported Outcomes for Medical Cannabis (MC-RWE) (NCT04526093) | Clinical Trial Compass
RecruitingNot Applicable
Real-World Evidence in Patient-Reported Outcomes for Medical Cannabis (MC-RWE)
Canada1,000 participantsStarted 2020-07-15
Plain-language summary
This prospective observational study aims to describe the effectiveness of MC on pain, epilepsy, sleep and /or anxiety/depression in a cohorts of patients authorized to use MC, using pre-defined, validated self assessment scales.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects (≥19 years of age) who are MC-naïve or -experienced with a medical authorization for MC provided by a prescribing health care practitioner and who have provided informed consent
* Primary therapeutic indications for MC use: pain, epilepsy, sleep, and/or anxiety/depression.
* Subjects agree to use verified products and refrain from using any other cannabis products, either medical or recreational, during the duration of the study
Exclusion Criteria:
* Concomitant use of illicit drugs
* Concomitant use of recreational cannabis
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in pain intensity from baseline to week 24 post-authorization of MC: Measured using the numerical rating scale (NRS).
Timeframe: Baseline, 6, 12, 18 (if applicable) and 24 weeks
2
Change in pain interference from baseline to week 24 post-authorization of MC: Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)-Pain Interference short form 6a.
Timeframe: Baseline, 6, 12, 18 (if applicable) and 24 weeks
3
Sleep: Change in the Pittsburgh Sleep Quality Index (PSQI) from baseline to week 24 post-authorization of MC
Timeframe: Baseline, 6, 12, 18 (if applicable) and 24 weeks
4
Anxiety: Change in the symptoms from baseline to week 24 post-authorization of MC; Measured using Generalized Anxiety Disorder 7-item scale (GAD-7).
Timeframe: Baseline, 6, 12, 18 (if applicable) and 24 weeks
5
Depression: Change in the symptoms from baseline to week 24 post-authorization of MC. Measured by Patient Health Questionnaire 9 item scale (PHQ-9).
Timeframe: Baseline, 6, 12, 18 (if applicable) and 24 weeks
6
Change in quality of life from baseline to Week 24: Measured using EuroQuol-5D-3-level health questionnaires(EQ-5D-3L) assessment scale.