Santa Cruz nonprofit MAPS could complete the first study of therapeutic whole-plant marijuana in 40 years
While stacks of independent research have affirmed the medicinal potentials of the cannabis plant, none received the official approval of the U.S. government. But soon we could be looking at the first federally sanctioned research to take place on marijuana in 40 years, outside of limited research by government organizations.
On March 14, marking a historic shift in U.S. drug policy, the Public Health Service (PHS) approved the protocols for a study of cannabis’ effects on 12 treatment-resistant combat veterans with Post Traumatic Stress Disorder (PTSD). The study is sponsored by the Santa Cruz-based Multidisciplinary Association for Psychedelic Studies (MAPS) and its protocols were already approved by the U.S. Food and Drug Administration (FDA) three years ago. They were also approved by the University of Arizona Institutional Review Board (IRB), and the University of Arizona has agreed to play host with psychiatrist and MD Sue Sisley as principal investigator.
MAPS has tried for more than 14 years to complete a federally sanctioned clinical research study of marijuana. So far, the National Institute on Drug Abuse (NIDA), which has a DEA-protected monopoly on the only legal supply of marijuana that can be used for FDA-regulated research, has refused to sell them cannabis. However, it seems that could be about to change.
A few years ago, Rick Doblin, executive director of MAPS, teamed up with Sisley to develop protocols for the PTSD study. In the United States, 22 veterans kill themselves per day according to statistics from the Department of Veterans Affairs, and often those suicides are related to PTSD symptoms. In recent years, more and more veterans have been speaking out about cannabis’ ability to mitigate PTSD. They say it doesn’t make them feel numb the way most prescription PTSD treatments do.
“This is a dire need, understanding PTSD, not just for combat vets but for all our citizens who are plagued by this,” Sisley said in a February article. “Any physician who’s also a human being can’t rest when we know that there’s something out there, in this case a plant, that has the potential to reduce human suffering.”
But while many vets are calling for increased access to marijuana medicine, the study in question would be the first-ever controlled, clinical study to look at using marijuana to treat PTSD in human patients.
Brad Burge, communications director for MAPS, notes that prior animal studies, among them a study using lab rats published in the scientific journal Nature, have shown that cannabis helps calm an overactive fear system.
Despite FDA approval, there was still a gaping problem until this month: In order to purchase NIDA weed, the PHS had to complete a third review process, as required by a 1999 guideline.
After the original study protocol was rejected by PHS in September 2011, MAPS resubmitted a revised protocol on Oct. 24, 2013. Then the line went dead for four months. Unlike FDA protocols, which require a response within 30 days, there is no timeline requiring PHS to respond. Finally, in the second week of March, PHS responded.
PHS approval matters because marijuana has more restrictions than any other illicit substance in the country. The federal government still lists it as a Schedule I substance—meaning a substance with “no currently accepted medical use and a high potential for abuse” according to the DEA. And, as required by the 1999 guideline, marijuana is the only Schedule I substance that requires an extra approval by the PHS, on top of FDA approval, before it can be studied. This makes pot the most difficult substance in the United States to research under federal law.
“If it can be shown that marijuana helps reduce depression and suicidality, which are things we want to explore in the study, then we can save a lot of lives,” says Burge, noting that the study would look at 50 vets, but would apply to anyone suffering from PTSD.
Burge notes that while the government does fund research and provide cannabis for some studies of isolated cannabinoids—for example looking just at THC or studies on synthetic cannabinoids—“they’re doing everything they can to prevent any form of research into the benefits of smoked, whole plant marijuana as a potential prescription medicine.”
While the PHS approval overcomes an enormous hurdle, MAPS still needs the DEA to sign off before it can purchase research-grade marijuana from NIDA. Then, the first government-approved, non-government study of marijuana in four decades can begin.
Via Good Times