Capsules containing cannabis extract, dissolved in high-oleic sunflower oil, and CBD/THC in a 16:1 ratio.

Capsules containing a high-oleic sunflower oil, calorie-equated to the active treatment. There will be no active compounds in the placebo treatment.
Following treatment with placebo, all participants in this group will begin treatment with medical cannabis.

Drug Resistant Epilepsy

The experimental intervention will begin with two weeks of titration (100 mg to 200 mg of CBD per day), followed by four weeks of treatment (maximum 300 mg of CBD per day) and four weeks of maintenance (maximum 300 mg of CBD per day). A two week washout phase will slowly decrease the daily dose (200 mg to 100 mg of CBD per day). All daily doses are equally divided into a morning and evening dose.

Medical Cannabis

The placebo intervention will begin with two weeks of titration, followed by four weeks of treatment. Participants will then be unblinded to their study group and begin two weeks of titration, four weeks of treatment, and two weeks of washout with medical cannabis, following the same dosing and schedule as the experimental group. All daily doses are equally divided into a morning and evening dose.

Placebo

University Hospital Campus, London Health Sciences Centre

University Health Network - Toronto Western Hospital

Cannabis Extract in Refractory Epilepsy Study

A Double-Blind, Placebo-Controlled, Parallel-Group Study of Cannabidiol Plus Tetrahydrocannabinol (CBD+THC) Given as Adjunctive Therapy in Patients With Refractory Seizures

QOLIE-31 is a 31-item measure assessing health-related quality of life in adults with epilepsy. Seven scales assess seizure worry, overall quality of life, emotional well-being, cognitive and medication effects, and social function.

WHOQOL-BREF is a 26-item measure of physical health, psychological health, social relationships, and environment.

QOLCE is a 55-item scale assessing health-related quality of life in children with epilepsy from the perspective of the parent or caregiver. It covers cognitive, emotional, social, and physical functioning.

NDDI-E is a 6-item questionnaire designed to screen for depression in adults with epilepsy.

QIDS is a 16-item measure designed to assess the severity of depressive symptoms.

GAD-7 is a 7-item questionnaire assessing severity of generalized anxiety disorder.

GASE is a single-item, 7-point global rating scale that was designed to assess the overall severity of epilepsy.

PSQI is a 19-item measure assessing subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication and daytime dysfunction.

PGIC is a 7-point scale assessing the patient's perspective of overall improvement and efficacy of treatment. Scores range from "very much improved" to "very much worse".

CGIC is a 7-point scale assessing the caregiver's perspective of overall improvement and efficacy of treatment. Scores range from "very much improved" to "very much worse".

BSI-53 is a 53-item measure assessing psychological profiles. It covers 9 primary domains: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism.

SDS is a 5-item measure assessing functional impairment in three inter-related domains: work/school, social, and family life.

cannabis indica/tonikas

Cannabis Extract in Refractory Epilepsy Study

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