Recruiting

MC

Sponsor:

University Health Network, Toronto

Code:

NCT04526093

Conditions

Pain

Sleep

Anxiety

Depression

Epilepsy

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Medical Cannabis

Study Details

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

Study ID

NCT04526093

Start date

Jul 15, 2020

Status verified date

Mar, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Interventions

Medical Cannabis

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

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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Epilepsy: change in seizure frequency for multiple different seizure types from baseline to Week 24 [ Time Frame: Baseline, 6, 12, 18 and 24 weeks ]

Central Contacts and Locations

Central contacts

Sonal Thaker

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

Locations

Toronto General Hospital, UHN

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Sonal Thaker

4163404800Sonalben.thaker@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jul 22, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-23. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-07-22.