Clinical trial NCT04526093: Real-World Evidence in Patient-Reported Outcomes for Medical Cannabis (MC-RWE)
Official title: MC-RWE : Real World Evidence in Patient-Reported Outcomes for Medical Cannabis: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pain
Sleep
Anxiety
Depression
Epilepsy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Avicanna Inc
First posted: 2020-08-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: Change in quality of life from baseline to Week 24: Measured using EuroQuol-5D-3-level health questionnaires(EQ-5D-3L) assessment scale.
timeFrame: Baseline, 6, 12, 18 (if applicable) and 24 weeks
measure: Epilepsy: change in seizure frequency for multiple different seizure types from baseline to Week 24
timeFrame: Baseline, 6, 12, 18 and 24 weeks
Secondary outcomes:
measure: Demographics
timeFrame: Baseline
measure: Clinical characteristics of patients
timeFrame: Baseline
measure: Patient satisfaction with the e-commerce platform's support team
timeFrame: 24 weeks after study initiation
measure: Changes in prescription medications of interest
timeFrame: 24 weeks after study initiation
Other outcomes:
measure: 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.
timeFrame: 6,12, 18 (if applicable) and 24 weeks after study initiation
measure: The proportion of patients who discontinued using MC during the course of the study as well the evaluation of the various reasons for this.
timeFrame: 6,12, 18 (if applicable) and 24 weeks after study initiation
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital, UHN
state: Ontario
Study officials:
affiliation: Toronto General Hospital, UHN
name: Hance Clarke, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: