Real-World Evidence in Patient-Reported Outcomes for Medical Cannabis (MC-RWE)

NCT04526093 | Recruiting

• 2 other identifiers: 20-553716560
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain; Sleep; Anxiety; Depression; Epilepsy

Outcome Measures

Primary Outcomes (7)

• Change in pain intensity from baseline to week 24 post-authorization of MC: Measured using the numerical rating scale (NRS).

  The 11-point NRS ranges from '0' being no pain to '10'' being the worst pain imaginable. Higher pain scores indicate greater pain intensity.

  Baseline, 6, 12, 18 (if applicable) and 24 weeks

• 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.

  The PROMIS-short form 6a measures six items on 5-point scales (1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit and 5=very much) for pain interference on aspects of daily life. Scores are calculated from the total of item responses, with higher scores reflecting greater pain interference.

  Baseline, 6, 12, 18 (if applicable) and 24 weeks

• Sleep: Change in the Pittsburgh Sleep Quality Index (PSQI) from baseline to week 24 post-authorization of MC

  The PSQI contains 19-self rated questions and 5-questions rated by the roommate or bed partner. The 19 self-rated questions are combined to form seven component scores, each of which has a range of 0-3 points (0=no difficulty to 3=severe difficulty). Higher scores indicate worse sleep quality.

  Baseline, 6, 12, 18 (if applicable) and 24 weeks

• Anxiety: Change in the symptoms from baseline to week 24 post-authorization of MC; Measured using Generalized Anxiety Disorder 7-item scale (GAD-7).

  This 7-item scale assesses the signs of GAD (e.g. ''Feeling afraid as if something awful might happen") with response option of : 0= Not at all, 1=Several days, 2= More than half the days and 3= Nearly everyday. Scores are calculated from the total of item responses, with higher scores reflecting greater anxiety.

  Baseline, 6, 12, 18 (if applicable) and 24 weeks

• Depression: Change in the symptoms from baseline to week 24 post-authorization of MC. Measured by Patient Health Questionnaire 9 item scale (PHQ-9).

  The PHQ-9 assesses the signs of depression (e.g. Little interest or pleasure in doing things) with response option of : 0= Not at all, 1= Several days, 2= More than half the days, 3= Nearly everyday. Scores are calculated from the total of item responses, with higher scores reflecting the severity of depression.

  Baseline, 6, 12, 18 (if applicable) and 24 weeks

• Change in quality of life from baseline to Week 24: Measured using EuroQuol-5D-3-level health questionnaires(EQ-5D-3L) assessment scale.

  The EQ-5D-3L assesses health state in each of 5 domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) on 3-point scale (no problems, some problems, extreme problems). Patients also rate their health on a vertical visual analogue scale with the endpoints "The best health you can imagine" and "The worse health you can imagine".

  Baseline, 6, 12, 18 (if applicable) and 24 weeks

• Epilepsy: change in seizure frequency for multiple different seizure types from baseline to Week 24

  Seizure frequency will be documented in a patient diary, and number of seizures of each seizure type in the preceding 6 weeks will be reported.

  Baseline, 6, 12, 18 and 24 weeks

Secondary Outcomes (4)

• Demographics

  Baseline

• Clinical characteristics of patients

  Baseline

• Patient satisfaction with the e-commerce platform's support team

  24 weeks after study initiation

• Changes in prescription medications of interest

  24 weeks after study initiation

Other Outcomes (2)

• The proportion of patients who have reported adverse effects due to MC use, as well as an assessment of the adverse effects based on different doses and methods of consumption.

  6,12, 18 (if applicable) and 24 weeks after study initiation

• The proportion of patients who discontinued using MC during the course of the study as well the evaluation of the various reasons for this.

  6,12, 18 (if applicable) and 24 weeks after study initiation

Interventions

Medical Cannabis OTHER

Verified medical cannabis products available within the current real-world study conform to Health Canada testing requirements

Also known as: Medical Marijuana

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Study participants (≥19 years of age) who are MC-naïve or -experienced with a medical document provided by a prescribing health care practitioner for the use of MC primarily for pain, epilepsy, sleep, and/or anxiety/depression. * Study participants who are either new or already registered with MyMedi.ca and consent to use verified products during the study. * Use of other cannabis products, either medical or recreational, is prohibited during the study period. Note: Although prohibited, the study cannot control for recreational cannabis use during the study.

You may qualify if:

• 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

You may not qualify if:

• Concomitant use of illicit drugs
• Concomitant use of recreational cannabis

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Avicanna Inc: collaborator

Study Sites (1)

Toronto General Hospital, UHN

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

MeSH Terms

Conditions

Pain; Anxiety Disorders; Depression; Epilepsy

Interventions

Medical Marijuana

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Hance Clarke, MD, PhD

  Toronto General Hospital, UHN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonal Thaker

CONTACT

416-340-4800 X 4251; sonalben.thaker@uhn.ca

Jo Carroll, RN

CONTACT

416-340-4800; Jo.carroll@uhn.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Manager

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 25, 2020
• Study Start: July 15, 2020
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

CA (1)