WASHINGTON, DC — Thousands of veterans and other medical marijuana patients nationwide use marijuana to treat symptoms of post-traumatic stress disorder (PTSD), but the U.S. Public Health Service (PHS) is blocking researchers who are seeking to learn more about the risks and benefits of the treatment.
A Food and Drug Administration (FDA) and University of Arizona Institutional Review Board (IRB)-approved protocol for a study of marijuana for symptoms of PTSD in U.S. veterans, sponsored by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), has been on hold for over 3½ months, as researchers wait for the PHS to respond to their request to purchase marijuana for the study.
The study would explore the safety and effectiveness of smoked and/or vaporized marijuana for 50 U.S. veterans with chronic, treatment-resistant PTSD. Animal studies have already shown that marijuana helps quiet an overactive fear system, but no controlled clinical studies have taken place with PTSD patients.
“This groundbreaking research could assist doctors in how to recommend treatment for PTSD patients who have been unresponsive to traditional therapies,” according to MAPS’ Executive Director Rick Doblin, Ph.D.
The PHS marijuana review process exists only because the National Institute on Drug Abuse (NIDA) has a Drug Enforcement Administration (DEA)-protected monopoly on the supply of marijuana legal for use in FDA-regulated research. This additional review is not required for research on any other Schedule I drug.
MAPS resubmitted a revised protocol on Oct. 24, 2013, after the original protocol was rejected by the PHS in September, 2011. Unfortunately, unlike the FDA, which must respond to submissions within 30 days of receiving them, the PHS has no such time limit. Meanwhile, the PHS is successfully preventing FDA and IRB-approved research from taking place.
PTSD is considered a life-threatening illness, as people suffering from PTSD are at increased risk of homelessness, drug abuse and alcoholism, and are more likely to commit suicide.
“If the PHS review requirement was removed,” says Dr. Sue Sisley, who would lead the study, “we would gather information that could help veterans today. The stifling of medical research on marijuana stands in the way of our vets returning to a normal life.”
SOURCE: Multidisciplinary Association for Psychedelic Studies (MAPS)