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

Study Overview
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Brief Summary
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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
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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. With the introduction of TruTrace™ verification, cannabis products can be clearly identified. Key information, including cannabinoid and terpene compositions can be collated into a Master Strain Certificate. With TruTrace™ verification, product quality can now be fully tracked. Thus: Patients who want to maintain a consistent MC treatment regimen will be able to do so using TruTrace™ verified products When patients desire a product and/or dosing change, TruTrace™ verification provides them accurate information about their starting strain and other strains that could replace or supplement it This study will provide much-needed pragmatic and objective information for patients and their clinicians about the effectiveness of TruTrace™ 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 2000 participants across the country. Digital patient consent will occur at the time of registration on the SDM e-commerce platform 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, they will be given access to TruTrace™ verified medical cannabis products (i.e., dried flower, oils, extracts and other cannabis product as they become approved and available) on the SDM e-commerce platform. 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.

Official Title
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MC-RWE : Real World Evidence in Patient-Reported Outcomes for Medical Cannabis: A Prospective Observational Study

Conditions
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Pain, Sleep, Anxiety, Depression, Epilepsy

Intervention / Treatment
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* Other: TruTrace™ verified Medical Cannabis products


Participation Criteria
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Eligibility Criteria
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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 TruTrace™ 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: TruTrace™ verified Medical Cannabis products|With the introduction of TruTrace™ verification, cannabis products can be clearly identified. Key information, including cannabinoid and terpene compositions can be collated into a Master Strain Certificate.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographics | Describe the demographic of patients (e.g. age, gender) authorized for MC in Canada using customized questionnaire. | 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. | Baseline | 
| Patient satisfaction with Medical Cannabis by Shoppers | The qualitative value of using the Medical cannabis by Shoppers platform and support services to the overall patient experience, as assessed by a customized questionnaire | 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. | 24 weeks after study initiation |