Vaporized Cannabis versus Placebo for Acute Migraine: A Randomized Controlled Trial
Nathaniel Schuster1, Mark Wallace1, Dawn Buse4, Thomas Marcotte2, Euyhyun Lee3, Lin Liu3, Michelle Sexton3
1Center for Pain Medicine, Department of Anesthesiology, 2Department of Psychiatry, 3Department of Family Medicine and Public Health, UC San Diego, 4Department of Neurology, Albert Einstein College of Medicine
Objective:
To test the efficacy of cannabis for acute migraine in a randomized, double-blind, placebo-controlled, crossover trial.
Background:
Preclinical and retrospective studies suggest anti-migraine effects of cannabinoids. The use of cannabinoids for migraine has broad patient interest and use but prior to this study lacked evidence of efficacy.  Here we present the results of the first RCT testing the efficacy of cannabis for the acute migraine treatment.
Design/Methods:

In this randomized, double-blind, placebo-controlled, crossover trial, adults with migraine treated up to 4 separate migraine attacks, 1 each with 4 different treatments. The 4 treatments were 1)6% THC; 2)11% CBD; 3)6% THC/11% CBD mix; and 4)Placebo flower from the NIDA Drug Supply Program. They were vaporized in a randomized order, with ≥1 week washout between treatments. The primary endpoint was pain relief at 2 hours from vaporization. Secondary endpoints were pain freedom and most bothersome symptom (MBS) freedom at 2 hours from vaporization.

Results:

92 participants were enrolled and randomized and 71 participants treated at least one migraine attack. Mean age was 41 and 82.6% were female. Participants entered 2-hour data for 234 attacks. THC/CBD mix was superior to placebo at achieving pain relief (67.2% vs 46.6%, p=0.016), pain freedom (34.5% vs. 15.5%, p=0.017) and MBS freedom (60.3% vs. 34.5%, p=0.005) at 2 hours, sustained pain freedom at 24 hours, and sustained MBS freedom at 24 and 48 hours. THC only was superior to placebo at achieving pain relief  (68.9% vs. 46.6%, p=0.008), but not pain freedom or MBS freedom at 2 hours. CBD only was not superior to placebo for any outcomes at 2 hours. There were no serious adverse events.

Conclusions:
Acute migraine treatment with vaporized cannabis flower containing 6% THC/11% CBD was efficacious at 2 hours post-treatment with sustained pain freedom at 24 hours and sustained MBS freedom at 24 and 48 hours.
10.1212/WNL.0000000000204925