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

University Health Network, Toronto

Status: Enrolling

Conditions: Epilepsy; Depression; Anxiety; Pain; Sleep

Treatments: Other: Medical Cannabis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04526093

20-5537

16560

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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