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The Michael Hooker Distinguished Professor and director of the NIMH psychoactive drug screening program at University of North Carolina School of Medicine discussed the need for large placebo-controlled trials of psychedelics in migraine disorders. [WATCH TIME: 4 minutes]
WATCH TIME: 4 minutes
“I would say we’re at the hypothesis testing phase. The clinical trials are going to get done, and we will ultimately have large, placebo-controlled phase 3 trials, probably for cluster headache, migraine headache, and other headache disorders—temporal neuralgia, that sort of thing—and we’ll know within a few years.”
The keynote address for the 2022 American Headache Society (AHS) Annual Scientific Meeting, June 9-11, in Denver, Colorado, included a thorough review of the history and potential of psychedelic drugs as possible therapies for medical conditions. Specifically, Bryan Roth, MD, PhD, who delivered the address, touched on the available evidence in migraine and cluster headache.
Although these drugs have shown some potential to improve headache disorders—among other conditions—there have been challenges in assessing these therapies. Namely in that the ability to properly blind clinical trial participants in placebo-controlled trials because of the psychedelic effects of these compounds. Additionally, much of the evidence that is available in favor these drugs as therapies is anecdotal, which presents challenges for researchers in determining their actual effectiveness.
Roth, who is the Michael Hooker Distinguished Professor and director of the NIMH psychoactive drug screening program at University of North Carolina School of Medicine, has been studying these agents for some time, thanks to federal funding in the form of an NIH grant. He explained in a conversation with NeurologyLive® about this lack of robust evidence and the challenges in conducting clinical trials in migraine. He also spoke to the difficulty in informing patients about these drugs given their legality and access in certain states amid this lack of data.
To read more of Roth’s work into psychedelics, he and Tristan D. McClure-Begley, PhD, recently published on the topic in Nature Reviews: Drug Discovery, which you can read here: The promises and perils of psychedelic pharmacology for psychiatry.