May 11, 2011
Pot for PTSD Gets FDA Go-Ahead
By: David Downs
East Bay Express
The FDA has approved MAPS’ study of marijuana for veterans for PTSD, but the National Institute on Drug Abuse’s continued insistence that marijuana is not a medicine (despite medical marijuana being legal in almost a third of the country) might prevent the study from ever happening. This well-researched article aptly summarizes the challenges faced by scientists wanting to do research on whole-plant marijuana.
Originally appearing at http://www.eastbayexpress.com/ebx/pot-for-ptsd-gets-fda-go-ahead/Content?oid=2630300.
Largely banned since 1940, the field of medical cannabis research in the United States is celebrating a symbolic sign of acceptance this month: the US Food and Drug Administration approval of a study that gives pot to veterans suffering chronic post-traumatic stress disorder. Dr. Rick Doblin, executive director of the nonprofit Multidisciplinary Association for Psychedelic Studies in Santa Cruz, California, said the FDA approved on April 28 his group’s protocol for a study on the effects of marijuana on symptoms of PTSD. According to the study plan, neurochemical research shows that pot may relieve chronic post-traumatic stress disorder symptoms by interacting with the brain’s endocannabinoid system.
Post-traumatic stress is a severe anxiety disorder that may appear after psychologically traumatic events. Veterans suffering from PTSD will often report flashbacks, nightmares, anger, hyper vigilance, and avoidance of stimuli associated with the trauma. Symptoms last longer than a month and lead to “clinically significant distress and impairment.”
Battle-damaged war veterans are already self-medicating with pot to treat symptoms like insomnia, anxiety, and depression, clinicians have found. The new study seeks to quantify the efficacy of those practices. Fifty veterans in Arizona will be the subject of the study, and they all have chronic PTSD — the most stubborn kind, Doblin said.
Pot “helps people not have nightmares,” Doblin explained. “They sleep better. That’s one of the main reasons why people use it. Another reason is it focuses people’s attention on the here and now. It moves them a little ways out of being burdened by the past.”
The FDA approval represents a historic landmark in cannabis research, Doblin said. It’s the first FDA-approved study in at least thirty years that would give cannabis to patients for home use. As a sign of how hesitant the FDA was, Doblin’s group had to assure the FDA that the veterans in the study would not go out and sell their weed on the street corner.
The study also calls for veterans to smoke weed with differing levels of active cannabinoids THC and CBD to determine if one, the other, or a balance of both proves more effective. Veterans will also either smoke or vaporize the plant to better test effects from different administrations of the drug.
Doblin said he was surprised that the FDA approved the study. He did not think the National Institute on Drug Abuse (NIDA) had the appropriate CBD-rich pot for the study, and that would force the FDA to reject it. NIDA controls the one federally legal pot farm in the nation, which is based in Mississippi and provides government-grown pot to a handful of federal patients, as well as researchers approved by the Drug Enforcement Administration.
But if history is any guide, NIDA will ultimately block the FDA-approved study from ever happening, said Doblin. NIDA must approve all research on pot, and their political goal is to ensure it never becomes legal, he said. NIDA states on its web site that it believes smoked marijuana is not a medicine, despite more than three thousand years of recorded medicinal use.
Doblin said NIDA has repeatedly denied approval of his group’s efforts to clinically study the use of cannabis to treat AIDS wasting and migraines — despite repeated FDA approvals. Doblin said the FDA is interested in pursuing cannabis science, but NIDA is not.
“I would like there to be praise for the FDA; they’re not doing anything unusual,” he said. “But NIDA, the Drug Czar’s office, and the DEA have bought into prohibition and prohibition doesn’t make sense if you put science first.
“The Obama administration has talked a big game about how science should not be impeded by politics,” Doblin continued. “He has disappointed us in major ways when it comes to drug-related science.”
Dutch phytochemist Arno Hazekamp, a director at European cannabis manufacturer Bedrocan, has said that modern science is simply not set up to accept whole-plant medicine. The last century of modern medicine has been built upon the so-called “one-molecule-one-target” principle, he has noted.
Conversely, cannabis has more than four hundred psychoactive molecules and interacts with a vital yet barely understood cellular signaling system called the endocannabinoid system — which accounts for its wide variety of reported effects.
Some stronger pot these days definitely can cause anxiety, not lessen it, Doblin notes. And not all PTSD sufferers may have the same reaction to the same pot, he said. But the drug is nontoxic, and has been found to provide energy and lift the mood of depressed PTSD sufferers, he said. It doesn’t treat the underlying psychological damage of war, however. “It’s more on the level of symptom relief. If they don’t use marijuana the next day or next night their symptoms usually come back,” Doblin said.
Doblin’s group has also been developing Ecstasy-assisted talk therapy for war veterans for about a decade. Few people know that NIDA has the unique authority to stop cannabis research, but it may not prevent research on other psychoactives such as LSD and Ecstasy. The euphoric, empathetic “love” drug Ectasy allows a vet to revisit traumatic memories and process them without panic and fear overwhelming his mind.
In preparation for an MDMA-talk session, Doblin sees his group stepping shell-shocked vets down off of prescription medications and onto pot — which leaves the system in eight hours, instead of weeks or months for prescription pills. A recent study of patients presenting at Medicann clinics in California found huge numbers of patients using pot in lieu of prescription sleep aids and mood adulterants.
But if NIDA rejects the newly approved study, it will be yet- another example of the government getting in the way of helping our troops, Doblin said. “There are a large number of people for whom this would work.”
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