FDA Approves Final Trials of MDMA as Post-Traumatic Stress Disorder Treatment

On 29 November 2016, the Food and Drug Administration opened the door to new exploration of treating post-traumatic stress disorder using the mood-altering drug methylenedioxymethamphetamine (usually shortened to MDMA and known colloquially as Ecstasy or Molly).

MDMA is currently classified as a Schedule 1 drug by the U.S. Drug Enforcement Administration, meaning that it currently has no listed therapeutic use and a large risk of abuse.

What is MDMA?

MDMA – sometimes called ecstasy or molly – is a synthetic psychoactive drug that alters mood and perception, causes euphoria and enhances pleasure. MDMA, the preferred drug of ravers, can be taken as a capsule, tablet or pill.

What’s being sold on the streets as ecstasy or molly may not actually be pure MDMA, though. According to the DEA, researchers have found much of what’s passed as MDMA contains methamphetamine, ketamine, cocaine, over-the-counter cough suppressants, diet supplements and caffeine. In fact, according to EcstasyData.org, an independent laboratory pill analysis program, 48 percent of pills sold as ecstasy tested so far this year contained only MDMA, while 10 percent had none at all. Yet just five years ago, less than 16 percent of pills sold as ecstasy contained any MDMA.

“A lot of things substitute MDMA in the street drug,” says Dr. Mithoefer, who has studied the drug with support from the Multidisciplinary Association for Psychedelic Studies, a nonprofit founded in the mid-1980s.

The National Institutes of Health claims ecstasy was created in Germany in the early 1900s. A small number of U.S. psychiatrists started using it on patients in the 1970s under the government’s supervision. Then, as the drug hit the underground scene in the 1980s, it was banned by the government.

In one previous trial, ecstasy was given to patients by the psychiatrist during therapy sessions as part of a larger treatment schedule. The patients, according to the New York Times, reported a 56 percent decrease in the severity of symptoms on average. By the end of the study, two-thirds of the patients no longer met the criteria for PTSD.

What are the side effects?

MDMA is not devoid of adverse side effects. According to the National Institute on Drug Abuse, people high on MDMA may experience nausea, muscle tension, increased appetite, sweating and chills, blurred vision and raised body temperature. Some of the more serious – and potentially fatal – risks include dehydration, high blood pressure, heart failure, kidney failure, and an irregular heartbeat.

While infrequent, people have died from recreational ecstasy use – most recently at the Hard Summer rave in Fontana, Califoria. Dr. Mithoefer said the most common cause of MDMA-related fatality is dehydration and heat stroke from “dancing all night in hot conditions without enough fluids.” In rare occasions, he added, some people have passed away from drinking too much water, cause the brain to swell.

Since MDMA elevates blood pressure and pulse, researchers had screened phase two trial participants for underlying cardiac conditions. That’s because a person with heart disease is more likely to have a potentially fatal stroke or heart attack. “Every drug has risks as well as benefits,” Dr. Mithoefer said. “Just because it’s been used in a controlled setting doesn’t mean [MDMA] can’t have risks.”

Where does research go from here?

Researchers anticipate that the FDA will approve the phase three protocol early next year. The phase three trials are then expected to begin this coming summer, with sites across the United States and Canada, and last at least three years. They hope to enroll at least 230 participants.
“I’m hopeful, because we’ve had very strong results in phase two, that we’ll have also strong results in phase 3,” he says.

If, in the end, the FDA and DEA do approve MDMA for therapeutic use, researchers recommend that it only be offered in licensed clinics where trained professionals can safely and effectively manage the drug. Similarly, Dr. Mithoefer notes, to how methadone is administered. “We think that would be the wisest way to do this,” he says.