4 puffs of cannabis flower containing THC ~4% administered by vaporizer using Foltin Uniform Puff Procedure for treatment of a moderate-severe migraine attack. The flower is from the United States National Institute on Drug Abuse (NIDA).

4 puffs of cannabis flower containing THC ~4% and CBD ~6% administered by vaporizer using Foltin Uniform Puff Procedure for treatment of a moderate-severe migraine attack. The flower is from the United States National Institute on Drug Abuse (NIDA).

4 puffs of cannabis flower containing CBD ~6% administered by vaporizer using Foltin Uniform Puff Procedure for treatment of a moderate-severe migraine attack. The flower is from the United States National Institute on Drug Abuse (NIDA).

4 puffs of cannabis flower from which the THC and CBD have been extracted administered by vaporizer using Foltin Uniform Puff Procedure for treatment of a moderate-severe migraine attack. The flower is from the United States National Institute on Drug Abuse (NIDA).

Migraine

Cannabis

4 puffs of vaporized flower containing THC ~4%

THC ~4%

4 puffs of vaporized flower containing CBD ~6%

CBD ~6%

4 puffs of vaporized flower containing THC ~4% and CBD ~6%

THC ~4% and CBD ~6%

4 puffs of vaporized flower from which the THC and CBD have been extracted

Sham Cannabis

Cannabis for Acute Migraine: a Randomized, Double-blind, Placebo-controlled, Crossover Trial

Efficacy of Inhaled Cannabis Versus Placebo for the Acute Treatment of Migraine: a Randomized, Double-blind, Placebo-controlled, Crossover Trial

Dichotomous endpoint of pain reduction defined as reduction from moderate/severe pain to mild/no pain

Dichotomous endpoint of reduction from moderate/severe pain to no pain

Dichotomous endpoint of resolution of most bothersome symptom (of photophobia, phonophobia, and nausea) selected at the beginning of the migraine prior to cannabis administration

Dichotomous endpoint of reduction from moderate/severe pain to mild/no pain

Dichotomous endpoint of resolution of photophobia

Dichotomous endpoint of resolution of phonophobia

Dichotomous endpoint of use of rescue medication

Dichotomous endpoint of absence of headache pain at 2 hours after dose, with no use of rescue medication and no relapse of headache pain

Dichotomous endpoint of absence of most bothersome symptom at 2 hours afer dose, with no use of rescue medication and no relapse of most bothersome symptom

Deidentified data will be shared in a manner TBD based on funding availability and journal requirements.

Nathaniel Schuster

Assistant Professor

University of California, San Diego

Migraine Research Foundation

Randomized, Double-blind, Placebo-controlled, Crossover Trial

The lower dose CBD group will start with CBD capsules 5 mg BID, then increase the dose every 4 days until on the target dose of 50 mg BID.

The higher dose CBD group will start with CBD capsules 5 mg BID and will increase every 4 days until on a target dose of 100 mg BID.

Chronic Migraine

CBD oil - purified to <1% THC in soft-gel capsules

CBD 50 mg BID

CBD 100 mg BID

Placebo

Cannabis for the Prophylactic Treatment of Migraine

Cannabis for the Prophylactic Treatment of Migraine: a Randomized Double-Blind Placebo-Controlled Clinical Trial

The MIDAS test assesses the impact of migraines on daily life. The score ranges between 0 and 21+ with a lower score indicating little or no disability and a higher score indicating severe disability.

The HIT-6 test score ranges between 36-78 with a higher score being associated with greater impact of headache on an individual's life.

The GAD-7 patient questionnaire is used as a screening tool for generalized anxiety disorder with scores ranging between 0-21. A higher score is associated with a probable diagnosis of severe anxiety.

The PHQ-9 questionnaire is a self-administered screening tool for depression. The questionnaire score can range between 0-27 with higher scores indicating severe depression.

The MSQ assesses the impact (restrictive, preventative and emotional) of migraine on an individual's quality of life.

The PSQI is a tool used to measure the quality of an individual's sleep. The PSQI is self-administered with a higher score indicating overall poor sleep.

Farnaz Amoozegar

MD, Assistant Professor

University of Calgary

Quetiapine + Placebo
quetiapine + placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day).

Quitiapine + Placebo

Quetiapine + Topiramate
Quetiapine + Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day).

Quetiapine + Topiramate

Total

Sex: Female, Male

Region of Enrollment

Change in timeline follow-back self-reported of joint equivalents per week from baseline to 16 weeks.

Quetiapine and Placebo
Quetiapine and placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day).

Quitiapine and Placebo

Quetiapine and Topiramate
Quetiapine and Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day).

Quetiapine and Topiramate

Change in Joints Per Week

Change in percent days of cannabis use per week from baseline to week 16.

Change in Percent Days of Cannabis Use Per Week

Overall Study

Melissa P. DelBello, MD

Bipolar Disorder

Cannabis-Related Disorder

placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day).

Quetiapine and placebo

topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day).

migraine disorders/kaņepes

Cannabis for Acute Migraine: a Randomized, Double-blind, Placebo-controlled, Crossover Trial

Cannabis for the Prophylactic Treatment of Migraine

Efficacy Study of Quetiapine Plus Topiramate for Reducing Cannabis Consumption and Bipolar Mania

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