The Multidisciplinary Association for Psychedelic Studies (http://www.maps.org) announced on November 2 that it received approval from the Food and Drug Administration (FDA) for its protocol to test MDMA (ecstasy) in the treatment of post-traumatic stress disorder (PTSD). The FDA action marks the first approval of trials of ecstasy as a therapeutic agent since the drug was made illegal in 1985.
"The FDA called and informed me that the protocol had been approved," MAPS founder and head Rick Doblin told DRCNet. "This shows that the demonization of MDMA is not a complete barrier to the development of its potential therapeutic uses," said Doblin, who hopes to develop ecstasy and other psychedelics into prescription medicines.
If approved by a university review board, the trials will take place at the Medical University of South Carolina under the supervision of psychiatrist Dr. Michael Mithoefer and his wife Annie, a psychiatric nurse. The study protocol calls for 12 people suffering from PTSD to be given ecstasy as they go through therapy for their disorder. Eight others will be given a placebo. Both sets of patients will also undergo 16 hours of therapy without drugs.
Prior to the banning of ecstasy after it became popular as a party drug among Texas college students in the mid-1980s, researchers had used it in a variety of therapeutic contexts, including PTSD, marital counseling, and in grappling with fatal illnesses. But research came to a screeching halt with ecstasy prohibition.
Some people would like to keep it that way. Dr. Alan Leshner, the retiring head of the National Institute on Drug Abuse (NIDA) and leader of the anti-ecstasy scare campaign, told the Wall Street Journal the proposed study was a dangerous waste of time. "I know of no evidence in the scientific literature that demonstrates the efficacy of ecstasy for any clinical indication," he sputtered. "And we don't give drugs of abuse to naïve subjects except under extraordinary circumstances."
Rick Doblin doesn't suffer such talk gladly. "Leshner and NIDA are engaged in science in the service of the drug war, not a rational risk-benefit analysis. If Leshner says there is no evidence of MDMA's therapeutic potential, it's because they've blocked the research," Doblin argued. "As for giving drugs to naïve subjects, these are extraordinary circumstances. All of these are patients who have had PTSD for at least six months and have not responded to six months of serotonin specific reuptake inhibitors, such as Prozac."
Doblin also told DRCNet the FDA needs more attention from drug reformers. "The FDA is going to be an essential agency to work with; it can be a way for us to progress. With only $5 million, we could do the research to get marijuana through the FDA. The drug reform movement needs to expand its strategies to work with this agency," said Doblin. "If we can create a legal context for these drugs, that will demonstrate that there are indeed instances where people can use them."
And stricken by the magnanimity of the moment, Doblin even offered to help NIDA create responsible education about ecstasy. "Nobody believes MDMA is harmless; we all understand there are some risks," he said. "We would like to work together with NIDA to get education that can be believed, not the propaganda we get from NIDA under Leshner. We need to recognize that the way drug warriors exaggerate the risk of MDMA makes them vulnerable. They've been terrified of the medical research into its benefits, but they need to live with the drug as it is, not as they wish to paint it."