Abstract Details

Title Vaporized Cannabis versus Placebo for Acute Migraine: A Randomized Controlled Trial

Topic Headache

Presentation(s) S22 - Advances in Migraine and Therapeutics (2:48 PM-3:00 PM)

Poster/Presentation
Number 010

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.

Objective To test the efficacy of cannabis for acute migraine in a randomized, double-blind, placebo-controlled, crossover trial.

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.

Authors/Disclosures
Nathaniel M. Schuster, MD (UC San Diego Center for Pain Medicine) PRESENTER	Dr. Schuster has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Schedule 1 Therapeutics. Dr. Schuster has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Averitas. Dr. Schuster has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ShiraTronics. Dr. Schuster has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Syneos. Dr. Schuster has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lohocla Research Corporation. Dr. Schuster has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Vertex. Dr. Schuster has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Vectura Fertin. Dr. Schuster has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Rapport Therapeutics. Dr. Schuster has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Eli Lilly & Co. Dr. Schuster has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Averitas. Dr. Schuster has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Pain Medicine Journal. Dr. Schuster has received personal compensation in the range of $100,000-$499,999 for serving as an Expert Witness for Various Law Firms and the State of California. The institution of Dr. Schuster has received research support from Migraine Research Foundation. The institution of Dr. Schuster has received research support from UCSD Academic Senate. The institution of Dr. Schuster has received research support from NINDS 1 R01 AT012048-01A1. The institution of Dr. Schuster has received research support from NCCIH 5R00AT009466-04. The institution of Dr. Schuster has received research support from NCCIH U24 NS115714. The institution of Dr. Schuster has received research support from NIH/HEAL EN21-01.
MARK WALLACE (University of California San Diego Health)	No disclosure on file
Dawn C. Buse, PhD (Dawn C. Buse, PhD)	Dr. Buse has received personal compensation for serving as an employee of Vector Psychometric Group. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie-Allergan. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lilly. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Collegium. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie-Allergan. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Buse has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Current Pain and Headache Reports. The institution of Dr. Buse has received research support from Amgen. The institution of Dr. Buse has received research support from FDA. The institution of Dr. Buse has received research support from National Headache Foundation.
Thomas Marcotte	No disclosure on file
Euyhyun Lee (ACTRI BERD)	No disclosure on file
Lin Liu (University of California, San Diego)	No disclosure on file
Michelle Sexton (UCSD)	No disclosure on file