DENVER, Colorado — Vaporized hashish containing tetrahydrocannabinol (THC) and cannabidiol (CBD) might present fast and sustained aid of acute migraine ache with no severe unwanted side effects, new analysis suggests.
“On this single heart randomized managed trial throughout 247 handled migraine assaults, 4 puffs of vaporized THC-CBD combine had been efficacious for acute migraine remedy,” mentioned examine investigator Nathaniel Marc Schuster, MD, with College of California San Diego Middle for Ache Drugs.
The prevalence of THC-CBD over placebo was “unlikely defined by unmasking on condition that in our blinding evaluation most sufferers who acquired THC truly didn’t suppose they acquired some THC,” Schuster mentioned.
He introduced the outcomes (Summary S22.010) on April 16 on the American Academy of Neurology (AAN) 2024 annual assembly.
Sustained Ache Aid
Preclinical and retrospective research level to antimigraine results of cannabinoids, but sturdy proof of efficacy from a randomized managed trial has been missing.
The researchers examined the efficacy of hashish for acute migraine in what they report is the primary randomized, double-blind, placebo-controlled, crossover trial of adults with migraine.
Contributors handled as much as 4 separate reasonable to extreme migraine assaults, every with one in all 4 totally different therapies. The 4 therapies had been: 6% THC, 11% CBD, a mixture of 6% THC and 11% CBD, or placebo flower from the Nationwide Institute on Drug Abuse that has an identical style and odor to the opposite merchandise.
The 4 therapies had been vaporized in a randomized order, with not less than 1 week washout between therapies. The first endpoint was ache aid at 2 hours from vaporization. Secondary endpoints had been freedom from ache and most bothersome symptom (MBS) at 2 hours from vaporization.
Of the 92 enrolled sufferers (imply age 41 years, 83% girls), 19 handled zero migraine assaults thus leaving 73 sufferers who handled a complete of 247 migraine assaults over the 1-year examine.
The THC-CBD combine was superior to placebo at attaining ache aid (67.2% vs 46.6%; P = .016), ache freedom (34.5% vs 15.5%; P = .017), and MBS freedom (60.3% vs 34.5%; P = .005) at 2 hours.
The THC-CBD combine was additionally superior to placebo for sustained ache freedom at 24 hours and sustained MBS freedom at 24 and 48 hours.
There have been no severe adversarial occasions. The THC-CBD combine was higher tolerated than THC-only was, with decrease charges of euphoria and cognitive impairment and decrease subjective highness, Schuster mentioned.
Adversarial occasions had been extra widespread with THC solely (vs THC-CBD) “and that is actually anticipated as a result of CBD is thought to deliver down the unwanted side effects of THC,” Schuster famous.
Summing up his presentation, Schuster mentioned, “That is one single-center examine, and, after all, we’d like extra information. We have to examine the charges of treatment overuse headache and the charges of hashish use dysfunction that will develop with using hashish for migraine.”
Cautious Optimism
Reached for remark, Hsiangkuo (Scott) Yuan, MD, PhD, Division of Neurology, Thomas Jefferson College, and director of scientific analysis, Jefferson Headache Middle, Philadelphia, Pennsylvania, famous that the “statistically vital” variations between THC-CBD vs placebo on 2-hour ache aid, ache freedom and MBS freedom are “actually very thrilling, particularly when no severe adversarial occasion was reported.”
“Since THC has a slim therapeutic window for analgesia (too excessive causes psychoactive unwanted side effects and will even worsen the ache), its dosing must be fastidiously managed. The examine was correctly designed to make sure uniform dosing from the vaporizer, which is normally safer than smoking or a vape pen and has a faster onset than ingestion for acute utilization,” Yuan, who was not concerned within the examine, advised Medscape Medical Information.
“Nonetheless, the optimum THC-CBD ratio and efficiency (% THC) for acute migraine stay to be studied. Maybe there may be an individualized dose that may be obtained by titration. We additionally do not know if the impact modifications after repeated use,” Yuan cautioned.
He additionally famous that hashish use was related to treatment use headache in a retrospective examine, “though the causality stays to be decided.”
“Whereas there was no severe adversarial occasion, it’s not utterly risk-free, particularly when hashish is used repeatedly for a brief period. Because the doctor doesn’t have direct management over what occurs on the dispensary, we have to counsel our sufferers extra fastidiously when recommending hashish/cannabinoids,” Yuan mentioned.
Total, he mentioned he’s “cautiously optimistic about hashish use for acute migraine.”
This was an investigator-initiated examine, with no industrial funding. Schuster has disclosed relationships with Schedule 1 Therapeutics, Averitas, Lundbeck, Eli Lilly, ShiraTronics, and Syneos. Prior to now 24 months, Yuan has served as a website investigator for Teva, AbbVie, Ipsen, Parema; acquired advisory/marketing consultant charges from Salvia, Pfizer, AbbVie, Cerenovus; and royalties from Cambridge College Press and MedLink.
