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UCSD Health begins clinical trial treating migraines with cannabis and CBD

First FDA-approved cannabis-based drug now available in the US
Posted at 3:00 PM, May 19, 2021
and last updated 2021-05-19 18:00:57-04

SAN DIEGO (CNS) - A team at UC San Diego Health is conducting the first known randomized, double-blind, placebo-controlled clinical trial looking at cannabis as a potentially effective treatment for acute migraines, and researchers put out a call Wednesday for participants.

Although there are numerous FDA-approved treatments on the market, experts say many patients are turning to cannabis products containing THC and/or CBD, an ingredient of cannabis that is not psychoactive, to treat their migraines.

"Many patients who suffer from migraines have experienced them for many years but have never discussed them with their physicians," said Dr. Nathaniel Schuster, a pain management specialist and headache neurologist at UCSD Health and investigator at the UCSD Center for Medicinal Cannabis Research.

"They are, rather, self-treating with various treatments, such as cannabis," he said. "Right now, when patients ask us if cannabis works for migraines, we do not have evidence-based data to answer that question."

About 20 participants are currently enrolled in the clinical trial, including Allison Knigge, who was in elementary school when she started to experience migraines that continued to get progressively worse as time went on, especially after the birth of her son.

"I would describe my migraines as a piercing pain," she said. "It feels like my brain is being squeezed. It causes extreme sensitivity to light and sound and horrible nausea. There have been times when I have been at a pain level of 6 or higher for approximately 25 days out of the month. They impact my quality of life."

Migraines produce symptoms that are often intense and debilitating. They cause severe throbbing or pulsating headaches, usually on one side of the head, often accompanied by nausea and sometimes vomiting and/or extreme sensitivity to light and sound. A migraine attack can last for hours or even days.

Knigge said she tried several medications over the years, but none have been able to fully manage her migraines.

"When Dr. Schuster introduced the trial to me, I decided I wanted to participate," she said. "I was at a point where I was willing to try anything that could help manage my migraines."

The goal is to enroll 90 participants who will be randomized to treat four separate migraine attacks with four different treatments; one each with THC, CBD, a combination of the two and a placebo. The products are administered via a vaporizer.

To qualify for the clinical trial, patients must experience migraines every month, must not be a regular cannabis user or use opioids, and must be age 21-65.

"I am proud and grateful to be part of a study that could lead to more tools in the toolbox for those of us who suffer from migraines," Knigge said.

Schuster said future studies would include comparing different doses of cannabinoids.

To learn more about the clinical trial and how to enroll, visit clinicaltrials.ucsd.edu or contact Phirum Nguyen at psnguyen@ucsd.edu or 858-822-3108.