Wired: DEA Accedes to Ecstasy Test

Originally appearing here.

After a monumental struggle by a small group of advocates who believe Ecstasy, or MDMA, can have beneficial health effects, the Drug Enforcement Agency has finally given the go-ahead to test the drug on patients with post-traumatic stress disorder. 

If Ecstasy proves to be an effective and safe treatment for post-traumatic stress disorder, therapists can sign legal prescriptions for the drug. The DEA gave researchers permission to test the drug on Feb. 24, according to the Multidisciplinary Association for Psychedelic Studies website, the organization funding the MDMA research. The first phase of the trial will include 12 trauma victims. Michael Mithoefer, a psychiatrist with a private practice in Charleston, South Carolina, had been working with Rick Doblin, the founder and president of MAPS for nearly four years to get the trial approved. In association with MAPS, Doblin has been trying to get MDMA clinical trials approved since even before the drug was oulawed.

“It’s been 20 years,” Doblin said. “We started trying to get research approved by the FDA as soon as the DEA moved to do make it illegal (in 1984).”

Ecstasy is known as a party drug, but before MDMA was outlawed in 1985, therapists were already using it to help patients better cope with life’s travails. When the DEA named MDMA a schedule 1 drug, meaning it has no known medical use and a high potential for abuse, some therapists continued their work in underground clinics.

Therapists as well as casual users have long believed that Ecstasy can help people suffering from post-traumatic stress and other psychological problems because the drug creates feelings of euphoria, warmth and empathy. Most say that combining the drug with therapy is key to helping patients learn to incorporate what they experience on the drug into their everyday lives.

“Many clinicians have suspected for a long time, and therapists have a lot of anecdotal information that MDMA has the potential to be very healing for people with a number of disorders including PTSD,” said Michael Klein, a psychologist with a private practice in San Francisco.

Following some preliminary MAPS-funded trials that showed MDMA would be safe for therapy, the FDA approved the trial in 2001. But several more hurdles remained. An independent review board had to approve the design of the trial, and since Ecstasy is a schedule 1 drug, in the same category as LSD and heroin, the DEA also had to give its stamp of approval.

In the new trial, study volunteers will receive two 125 milligram doses of pure 3,4-methylenedioxymethamphetamine (MDMA) synthesized by a chemist at Purdue University. A control group will receive a placebo. Patients will take the medication on two separate occasions spaced three to five weeks apart, combined with talk therapy sessions. Patients will stay overnight at an unidentified clinic when they receive the drug.

Mithoefer said he was expecting the DEA’s decision any day, because he knew the study fulfilled all of the agency’s requirements.

“If there’s an FDA approved study, the DEA can only deny the license if there’s something like a felony, a drug conviction or some reason to think there would be diversion of the MDMA,” Mithoefer said. He also has a safe bolted to the floor in his office, as well as an alarm system, to help ensure the drug does not fall into the wrong hands.

In September 2002, the MAPS effort hit a speed bump when a longtime opponent of Ecstasy, George Ricaurte, published alarming data, the first to show that MDMA damaged dopamine neurons. But almost exactly a year later, Ricaurte retracted the study because he discovered he had mistakenly used a different drug, methamphetamine, instead of Ecstasy, in the trial.

Ricaurte and his wife, Una McCann, have published much of the data used by the National Institute on Drug Abuse to warn people about the dangers of Ecstasy. But even Ricaurte and McCann say if the study is properly designed and controlled, they don’t have a problem with it. The key issue, they said, is that the patients know the risks associated with the drug as well as the likelihood that they might benefit from it.

“These include (but are not limited to) adverse events related to the acute pharmacological effects of MDMA and the potential for brain serotonin neurotoxicity,” Ricaurte said. “If subjects are fully informed of these risks and still chose to participate, and if the protocol has been deemed scientifically and ethically acceptable by the appropriate regulatory bodies, then it should be held to the same standards as other clinical research projects.”

Rick Doblin, director and founder of MAPS has said he believes Ricaurte’s research is politically motivated, and the retraction is evidence that all of his research should be reevaluated.