DENVER — , new research suggests.
“In this single-center randomized controlled trial across 247 treated migraine attacks, four puffs of vaporized THC-CBD mix were efficacious for acute migraine treatment,” said study investigator Nathaniel Marc Schuster, MD, with University of California San Diego Center for Pain Medicine.
The superiority of THC-CBD over placebo was “unlikely explained by unmasking given that in our blinding analysis most patients who got THC actually did not think they got some THC,” Dr. Schuster said.
He presented the results at the 2024 annual meeting of the American Academy of Neurology.
Sustained Pain Relief
Preclinical and retrospective studies point to antimigraine effects of cannabinoids, yet strong evidence of efficacy from a randomized controlled trial has been lacking.
The researchers tested the efficacy of cannabis for acute migraine in what they report is the first randomized, double-blind, placebo-controlled, crossover trial of adults with migraine.
Participants treated up to four separate moderate to severe migraine attacks, each with one of four different treatments. The four treatments were: 6% THC, 11% CBD, a mix of 6% THC and 11% CBD, or placebo flower from the National Institute on Drug Abuse that has a similar taste and smell to the other products.
The four treatments were vaporized in a randomized order, with at least 1 week washout between treatments. The primary endpoint was pain relief at 2 hours from vaporization. Secondary endpoints were freedom from pain and most bothersome symptom (MBS) at 2 hours from vaporization.
Of the 92 enrolled patients (mean age 41 years, 83% women), 19 treated zero migraine attacks thus leaving 73 patients who treated a total of 247 migraine attacks over the 1-year study.
The THC-CBD mix was superior to placebo at achieving pain relief (67.2% vs 46.6%; P = .016), pain freedom (34.5% vs 15.5%; P = .017), and MBS freedom (60.3% vs 34.5%; P = .005) at 2 hours.
The THC-CBD mix was also superior to placebo for sustained pain freedom at 24 hours and sustained MBS freedom at 24 and 48 hours.
There were no serious adverse events. The THC-CBD mix was better tolerated than THC-only was, with lower rates of euphoria and cognitive impairment and lower subjective highness, Dr. Schuster said.
Adverse events were more common with THC only (vs THC-CBD) “and this is really expected because CBD is known to bring down the side effects of THC,” Dr. Schuster noted.
Summing up his presentation, Dr. Schuster said, “This is one single-center study, and, of course, we need more data. We need to study the rates of medication overuse headache and the rates of cannabis use disorder that may develop with the use of cannabis for migraine.”
Cautious Optimism
Reached for comment, Hsiangkuo (Scott) Yuan, MD, PhD, Department of Neurology, Thomas Jefferson University, and director of clinical research, Jefferson Headache Center, Philadelphia, Pennsylvania, noted that the “statistically significant” differences between THC-CBD versus placebo on 2-hour pain relief, pain freedom and MBS freedom are “certainly very exciting, especially when no serious adverse event was reported.”