PainMC-RWENCT04526093
Real-World Evidence in Patient-Reported Outcomes for Medical Cannabis (MC-RWE)
An observational study of Pain and Sleep, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- What is being tested?
- Medical Cannabis
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jul 2020to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Concomitant use of illicit drugs
- Concomitant use of recreational cannabis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital, UHN
Toronto, Ontario, M5G 2C4
Sonal Thaker, 4163404800 ext. 4251, Sonalben.thaker@uhn.ca
About this study
Official title: MC-RWE : Real World Evidence in Patient-Reported Outcomes for Medical Cannabis: A Prospective Observational Study
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.
Read the detailed description
Given the recent legislative changes, medical cannabis has quickly garnered attention in clinical research as a potential pharmacotherapy to treat epilepsy, mood disorders, anxiety/depression disorders, sleep disorders and pain (neuropathic and non-cancer chronic pain)-conditions with often debilitating patient impact, substantive economic burden, and limited treatment options.
While there is growing evidence that MC may be an effective therapeutic option for patients suffering from chronic medical conditions, clinical research on medical cannabis has focused primarily on short-term outcomes, with limited attention to long-term benefits of specific strains, dosing regimens or treatment modalities. In addition, patients using MC generally are unable to maintain a defined treatment regimen (whether defined by strain name, biochemical composition, or mode of ingestion) over a long period of time. Even for patients desiring to maintain treatment with the same regimen, it may be impossible to do so, given the tendency for recreational and licensed medical producers to change their strains and product line up without notice. Such changes complicate MC users' efforts to optimize their overall health outcomes, as well as researchers' ability to study long-term effectiveness and safety of MC in general, and specific strains in particular.
Over the last few years, there has been an influx of new growers and an introduction of many new cannabis strains, each with a different representation of at least 500 known metabolites. Subtle changes in strain composition may have significant clinical effects. With so many strains available, and with limited information on strain composition and genetics, patients have little ability to control what they are taking over time.
The current real-world study addresses these complexities by providing patients verified MC strains and products, allowing them to maintain their treatment if desired or alter its composition in order to identify dosing regimens that work for them.
This study will provide much-needed pragmatic and objective information for patients and their clinicians about the effectiveness of verified MC products in the real-world setting using validated patient report outcome (PRO) tools.
The first study, of its kind in Canada, aims to recruit 1000 participants across the country. Digital patient consent will occur at the time of registration on the Avicanna's e-commerce platform(MyMedi.ca) when the study participant registers to purchase their MC and agrees to be part of the MC-RWE observational study.
Once a study participant is registered in the study and completed the baseline questionnaires, they will be given access to verified medical cannabis products (i.e., dried flower, oils, extracts and other cannabis product as they become approved and available) on the MyMedi.ca platform. Participants in the epilepsy group will be given access to verified medical cannabis products once they have completed baseline seizure frequency reporting at 6 weeks after enrollment in the study. This is a novel innovation within the Canadian Cannabis Industry.
Study participants will be administered a number of validated questionnaires upon study initiation, including an enrollment questionnaire that asks about medical history and specific questionnaires for pain, sleep, anxiety/depression. In addition, all participants will complete a health-related quality of life questionnaire.
All questionnaires will be self-administered online at time points Baseline, 6, 12, 18 (if applicable) and 24 weeks.
- Conditions
- Pain, Sleep, Anxiety, Depression, Epilepsy
- Being tested
- Medical Cannabis
- Medical subject headings
- Pain, Anxiety Disorders, Depression, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical CannabisOther
Also called Medical Marijuana
Verified medical cannabis products available within the current real-world study conform to Health Canada testing requirements
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: Baseline, 6, 12, 18 and 24 weeks
Secondary outcomes (4)
Demographics
Describe the demographic of patients (e.g. age, gender) authorized for MC in Canada using customized questionnaire.
Measured: Baseline
Clinical characteristics of patients
Describe the Clinical characteristics (e.g. comorbidities, concomitant medications, etc.) of patients authorized for MC in Canada using customized questionnaire.
Measured: Baseline
Patient satisfaction with the e-commerce platform's support team
The qualitative value of using the e-commerce platform and support services to the overall patient experience, as assessed by a customized questionnaire
Measured: 24 weeks after study initiation
Changes in prescription medications of interest
Change in use of concomitant medications (e.g., opioids, anti-depressants, anxiolytics, high-dosage anti-inflammatories, antiepileptic drugs) over time on study, assessed by customized questionnaire.
Measured: 24 weeks after study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start15 Jul 2020
- Primary completionMar 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Avicanna Inc
- Responsible party
- Sponsor
- Investigators
- Hance Clarke, MD, PhD, Principal investigator, Toronto General Hospital, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526093
- Sponsor's protocol ID
- 24-5779
- Other IDs
- 16560
- Acronym
- MC-RWE
- Status last verified
- Mar 2026
- First submitted
- 17 Aug 2020
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MC-RWE : Real World Evidence in Patient-Reported Outcomes for Medical Cannabis: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04526093
- Acronym / sponsor ID
- MC-RWE / 24-5779
- Conditions
- Pain, Sleep, Anxiety, Depression, Epilepsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Avicanna Inc
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 25 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Given the recent legislative changes, medical cannabis has quickly garnered attention in clinical research as a potential pharmacotherapy to treat epilepsy, mood disorders, anxiety/depression disorders, sleep disorders and pain (neuropathic and non-cancer chronic pain)-conditions with often debilitating patient impact, substantive economic burden, and limited treatment options.
While there is growing evidence that MC may be an effective therapeutic option for patients suffering from chronic medical conditions, clinical research on medical cannabis has focused primarily on short-term outcomes, with limited attention to long-term benefits of specific strains, dosing regimens or treatment modalities. In addition, patients using MC generally are unable to maintain a defined treatment regimen (whether defined by strain name, biochemical composition, or mode of ingestion) over a long period of time. Even for patients desiring to maintain treatment with the same regimen, it may be impossible to do so, given the tendency for recreational and licensed medical producers to change their strains and product line up without notice. Such changes complicate MC users' efforts to optimize their overall health outcomes, as well as researchers' ability to study long-term effectiveness and safety of MC in general, and specific strains in particular.
Over the last few years, there has been an influx of new growers and an introduction of many new cannabis strains, each with a different representation of at least 500 known metabolites. Subtle changes in strain composition may have significant clinical effects. With so many strains available, and with limited information on strain composition and genetics, patients have little ability to control what they are taking over time.
The current real-world study addresses these complexities by providing patients verified MC strains and products, allowing them to maintain their treatment if desired or alter its composition in order to identify dosing regimens that work for them.
This study will provide much-needed pragmatic and objective information for patients and their clinicians about the effectiveness of verified MC products in the real-world setting using validated patient report outcome (PRO) tools.
The first study, of its kind in Canada, aims to recruit 1000 participants across the country. Digital patient consent will occur at the time of registration on the Avicanna's e-commerce platform(MyMedi.ca) when the study participant registers to purchase their MC and agrees to be part of the MC-RWE observational study.
Once a study participant is registered in the study and completed the baseline questionnaires, they will be given access to verified medical cannabis products (i.e., dried flower, oils, extracts and other cannabis product as they become approved and available) on the MyMedi.ca platform. Participants in the epilepsy group will be given access to verified medical cannabis products once they have completed baseline seizure frequency reporting at 6 weeks after enrollment in the study. This is a novel innovation within the Canadian Cannabis Industry.
Study participants will be administered a number of validated questionnaires upon study initiation, including an enrollment questionnaire that asks about medical history and specific questionnaires for pain, sleep, anxiety/depression. In addition, all participants will complete a health-related quality of life questionnaire.
All questionnaires will be self-administered online at time points Baseline, 6, 12, 18 (if applicable) and 24 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Concomitant use of illicit drugs
- Concomitant use of recreational cannabis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical CannabisAlso: Medical MarijuanaVerified medical cannabis products available within the current real-world study conform to Health Canada testing requirements | Other | – |
Primary outcome
Change in pain intensity from baseline to week 24 post-authorization of MC: Measured using the numerical rating scale (NRS).
Time frame: Baseline, 6, 12, 18 (if applicable) and 24 weeks
The 11-point NRS ranges from '0' being no pain to '10'' being the worst pain imaginable. Higher pain scores indicate greater pain intensity.
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.
Time frame: Baseline, 6, 12, 18 (if applicable) and 24 weeks
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.
Sleep: Change in the Pittsburgh Sleep Quality Index (PSQI) from baseline to week 24 post-authorization of MC
Time frame: Baseline, 6, 12, 18 (if applicable) and 24 weeks
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.
Anxiety: Change in the symptoms from baseline to week 24 post-authorization of MC; Measured using Generalized Anxiety Disorder 7-item scale (GAD-7).
Time frame: Baseline, 6, 12, 18 (if applicable) and 24 weeks
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.
Depression: Change in the symptoms from baseline to week 24 post-authorization of MC. Measured by Patient Health Questionnaire 9 item scale (PHQ-9).
Time frame: Baseline, 6, 12, 18 (if applicable) and 24 weeks
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.
Change in quality of life from baseline to Week 24: Measured using EuroQuol-5D-3-level health questionnaires(EQ-5D-3L) assessment scale.
Time frame: Baseline, 6, 12, 18 (if applicable) and 24 weeks
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".
Epilepsy: change in seizure frequency for multiple different seizure types from baseline to Week 24
Time frame: Baseline, 6, 12, 18 and 24 weeks
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.
4 secondary outcomes
Demographics
Time frame: Baseline
Clinical characteristics of patients
Time frame: Baseline
Patient satisfaction with the e-commerce platform's support team
Time frame: 24 weeks after study initiation
Changes in prescription medications of interest
Time frame: 24 weeks after study initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hance Clarke, MD, PhD principal investigator
Toronto General Hospital, UHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Sleep, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sonal Thaker (416-340-4800 X 4251 ext. 4251, sonalben.thaker@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity from baseline to week 24 post-authorization of MC: Measured using the numerical rating scale (NRS). (time frame: Baseline, 6, 12, 18 (if applicable) and 24 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.