Vaporized Cannabis versus Placebo for Acute Migraine: A Randomized Controlled Trial
Nathaniel M Schuster 1 2, Mark S Wallace 1 2, Thomas D Marcotte 3 2, Dawn C Buse 4, Euyhyun Lee 5, Lin Liu 6, Michelle Sexton 7 2
- 1Center for Pain Medicine, Department of Anesthesiology, University of California, San Diego Health System, San Diego, CA.
- 2Center for Medicinal Cannabis Research, University of California, San Diego Health System, San Diego, CA.
- 3Department of Psychiatry, University of California, San Diego Health System, San Diego, CA.
- 4Department of Neurology, Albert Einstein College of Medicine.
- 5Altman Clinical and Translational Research Institute, University of California, San Diego Health System, San Diego, CA.
- 6Department of Biostatistics and Bioinformatics, Herbert Wertheim School of Public Health and Human Longevity Science, University of California, San Diego Health System, San Diego, CA.
- 7Centers for Integrative Health, Department of Family Medicine, University of California, San Diego Health System, San Diego, CA.
Affiliationer
Background: Preclinical and retrospective studies suggest cannabinoids may be effective in migraine treatment. However, there have been no randomized clinical trials examining the efficacy of cannabinoids for acute migraine.
Methods: In this randomized, double-blind, placebo-controlled, crossover trial, adults with migraine treated up to 4 separate migraine attacks, 1 each with vaporized 1) 6% Δ9-tetrahydrocannabinol (THC-dominant); 2) 11% cannabidiol (CBD-dominant); 3) 6% THC+11% CBD; and 4) placebo cannabis flower in a randomized order. Washout period between treated attack was ≥1 week. The primary endpoint was pain relief and secondary endpoints were pain freedom and most bothersome symptom (MBS) freedom, all assessed at 2 hours post-vaporization.
Results: Ninety-two participants were enrolled and randomized, and 247 migraine attacks were treated. THC+CBD was superior to placebo at achieving pain relief (67.2% vs 46.6%, Odds Ratio [95% Confidence Interval] 2.85 [1.22, 6.65], p=0.016), pain freedom (34.5% vs. 15.5%, 3.30 [1.24, 8.80], p=0.017) and MBS freedom (60.3% vs. 34.5%, 3.32 [1.45, 7.64], p=0.005) at 2 hours, as well as sustained pain freedom at 24 hours and sustained MBS freedom at 24 and 48 hours. THC-dominant was superior to placebo for pain relief (68.9% vs. 46.6%, 3.14 [1.35, 7.30], p=0.008) but not pain freedom or MBS freedom at 2 hours. CBD-dominant was not superior to placebo for pain relief, pain freedom or MBS freedom at 2 hours. There were no serious adverse events.
Conclusions: Acute migraine treatment with 6% THC+11% CBD was superior to placebo at 2 hours post-treatment with sustained benefits at 24 and 48 hours.