20 May 2021. A clinical trial is enrolling participants to test three different types of inhaled cannabis therapies against a placebo to treat migraine. The trial is conducted by the Center for Medicinal Cannabis Research at University of California in San Diego and funded by the Migraine Research Foundation.
Migraine is a neurological syndrome causing severe headaches along with nausea, vomiting, and extreme sensitivity to light and sound, making sufferers unable to work or function in most cases. In some instances, migraines are preceded by warning episodes called aura including flashes of light, blind spots, or tingling in arms and legs. Migraine Research Foundation says the disorder is the third-most prevalent illness in the world, affecting some 1 billion people, including 39 million in the U.S. And while most people with migraines suffer one or two episodes a month, more than 4 million people experience chronic migraines, defined as at least 15 days each month with migraines.
While FDA has approved numerous treatments for migraine, many patients are turning to cannabis therapies on their own, according to Nathaniel Schuster, a neurologist at UC San Diego medical center and the clinical trial’s lead scientist. “Many patients who suffer from migraines have experienced them for many years but have never discussed them with their physicians,” says Schuster in a university statement. “They are, rather, self-treating with various treatments, such as cannabis.”
The therapies in this case are derived from the Cannabis sativa plant, also known as marijuana. National Library of Medicine in the U.S. says some 80 chemicals, known as cannabinoids, are associated with these plants. One of those chemicals, cannabidiol, or CBD, a non-intoxicating derivative, makes up about 40 percent of cannabis extracts and has been studied extensively for a range of disorders, including to treat some forms of epilepsy, approved by FDA. The psychoactive component of marijuana causing intoxication is tetrahydrocannabinol or THC.
Testing each treatment when a migraine occurs
The mid-stage clinical trial aims to enroll 120 adults experiencing migraines, and is testing three types of inhaled cannabis derivatives as migraine treatments: CBD alone, THC alone, and a combination of CBD and THC. The cannabis chemicals are diluted to specified concentrations, 5 percent for THC and 12 percent for CBD, then converted into an inhaled form with a standard portable vaporizer device.
Participants are given each of these three treatments and a placebo formulation, along with the vaporizer, and asked to inhale four puffs of a treatment when they begin to experience a migraine. The test treatments and placebo are packaged identically with unique code numbers, with participants instructed to take the treatments in a specified random order.
The study team is looking primarily for the extent of migraine pain relief in the two hours following treatment. The researchers are also asking participants to indicate amount of time participants are free of headache pain in those two hours, as well as relief from what they consider their most troublesome symptom besides pain, such as nausea or fear of light or sound.
“Right now,” notes Schuster, “when patients ask us if cannabis works for migraines, we do not have evidence-based data to answer that question.” The researchers say this is the first known randomized, blinded, placebo-controlled clinical trial to study cannabis as a treatment for acute migraines.
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