Dr. Sue Sisley says she was abruptly fired in 2014 from a faculty position at the University of Arizona when her long planned study of cannabis as a treatment for PTSD became a political hot button among local politicians. Sisley ultimately prevailed, and now serves as one of two principal investigators in a multi-site study sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) and funded by a $2.1 million grant from the Colorado Department of Public Health and Environment.
The world’s first controlled clinical trial evaluating smoked medical cannabis as a treatment for PTSD is a triple-blind, outpatient, randomized, placebo-controlled study of 76 combat veterans randomly assigned either a high-THC strain, a high-CBD strain, a 1:1 THC/CBD ratio strain, or a placebo. Currently in its third year, the study has proceeded well, but in the meantime, PTSD-related suicides remain at epidemic levels among US combat veterans.
In direct response to a flood of inquiries from parents of epileptic children, the US federal government in 2014 quietly fast-tracked a trial of cannabidiol (CBD) as a treatment for seizure disorders, proving that political pressure can indeed push them to approve studies into the potential benefits of cannabinoids. But while many advocates sought to test whole-plant or full-spectrum medicines, the study has been strictly limited to a single compound found in cannabis—not coincidentally one supplied in “purified” form by GW Pharmaceuticals, which also funded the study, and is currently seeking FDA approval to sell the a prescription CBD medicine called Epidiolex.
In May 2018, the New England Journal of Medicine published an update on this ongoing research showing that patients taking just 20mg of CBD per kilogram of body weight had 42% fewer seizures, on average, compared with a 17% reduction in the placebo group.
According to a comprehensive report on the study from Leafly’s Ryan Basen, these extremely promising results have GW Pharmaceutical’s CBD drug on track for imminent FDA approval.
“If approved, Epidiolex would become the first medication derived from the cannabis plant allowed in the US. The FDA has previously approved synthetic cannabis medications, which more closely resemble tetrahydrocannabinol (THC), but nothing plant-derived nor anything featuring CBD.
Sativex, a GW Pharma product that incorporates both THC and CBD, has been approved for medical use outside the U.S. Epidiolex features a solution of 100 mg/ml of CBD dissolved in sesame oil, ethanol, sweetener, and a flavoring agent, according to the FDA review. The medication is harvested from cannabis plants specifically bred for medical purposes, with high CBD concentration, according to a GW Pharmaceuticals report.”