MAPS: Public Health Service Blocks FDA-Approved Medical Marijuana Research For Veterans With PTSD - Applied Clinical Trials

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MAPS: Public Health Service Blocks FDA-Approved Medical Marijuana Research For Veterans With PTSD


MAPS: Public Health Service Blocks FDA-Approved Medical Marijuana Research For Veterans With PTSD

PR Newswire

WASHINGTON, Feb. 21, 2014 /PRNewswire-USNewswire/ -- Thousands of veterans and other medical marijuana patients nationwide use marijuana to treat symptoms of posttraumatic 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."

Founded in 1986, the Multidisciplinary Association for Psychedelic Studies (MAPS) is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. MAPS is the only organization working to evaluate the safety and efficacy of botanical marijuana as a prescription medicine for specific medical uses approved by the FDA.

SOURCE Multidisciplinary Association for Psychedelic Studies (MAPS)

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