Researchers who want to study medical marijuana as a treatment for PTSD say the U.S. government is making it very hard to do so.

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The non-profit Multidisciplinary Association For Psychedelic Studies (MAPS) is trying to obtain a supply of cannabis for the first FDA-approved clinical trial of medical marijuana for post-traumatic stress disorder.

Many who suffer from PTSD have reported benefits from cannabis use, and evidence from animal studies provides further support.

Unfortunately, despite the availability of medical marijuana in certain states, the National Institute on Drug Abuse (NIDA) is the only legal source of cannabis for researchers. And compared to the FDA, getting NIDA’s approval for a clinical trial has proven a lot harder.

The team at MAPS, led by Dr. Sue Sisley of the University of Arizona College of Medicine, first approached NIDA to purchase cannabis in 2011, after getting the go-ahead from the FDA. NIDA unanimously rejected the proposal, supposedly due to flaws in the study’s design.

“They approved it, but NIDA disagreed”

“They came to us with all of these critiques,” explains MAPS communication director Brad Burge.

“Of course, at that point, the FDA had not had any problem with any of the scientific issues involving the study. So the Food and Drug Administration, which is the organization that’s responsible for monitoring clinical research of the sort we’re proposing to conduct, didn’t have any problem with the study. They approved it, but NIDA disagreed.”

NIDA also wanted MAPS to get clearance from an institutional review board, which is usually only mandated when the ethics of a study are questionable. Regardless, MAPS addressed the critiques and got review board approval in 2012.

After trying to fight NIDA’s cannabis monopoly in court, and losing, MAPS resubmitted the proposal last October.

They are now waiting to hear back from NIDA. It’s been more than four months without a word, says Burge. Unfortunately, while the FDA must respond to research proposals in 30 days, NIDA can take as long as they want.

Then again, requests like MAPS’ don’t come often. MAPS has an interest in a variety of psychedelic therapies – which have garnered notable support in recent years.

“Marijuana is the only one”

In fact, the organization is currently studying MDMA for the treatment of PTSD.

One study has already been completed, and another is ongoing. But while MDMA is also a Schedule I substance, neither studies required NIDA’s approval.

“For research on all other drugs, you only have to go through the FDA,” says Burge. “The only time NIDA is reviewing clinical research – that is, research to make a drug into a medicine – marijuana is the only one.”

Source | LeafScience


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