The Drug Enforcement Administration last week gave a green light to a clinical study that will test the safety and efficacy of MDMA for use in treating anxiety in people with life-threatening illnesses. The move suggests the DEA may be questioning its long-held position that the psychedelic compound, which can be a component in street drugs like Molly or Ecstasy, has no accepted medical use.
At the height of the drug war in 1985, the agency classified MDMA in Schedule I under the Controlled Substances Act. The federal government considers Schedule I drugs to be among the "most dangerous," with no known medical benefits and the potential for "severe psychological or physical dependence." That decision overruled a previous recommendation by the DEA's chief administrative law judge that the drug be placed in Schedule III, which would have allowed doctors to continue using it in therapy.
In the years since, members of the medical community have continued to argue that MDMA doesn't belong in Schedule I. Some recent studies, also approved by the DEA, have found that the drug could be an effective treatment for post-traumatic stress disorder when administered under proper supervision.
The latest study is being sponsored by the Multidisciplinary Association for Psychedelic Studies, a nonprofit organization that funds research on beneficial uses of psychedelics and marijuana. MAPS sees the DEA's approval as a sign of change.
"The smooth process of regulatory approval for this study indicates that stigma is no longer standing in the way of regulatory approval for research into the therapeutic uses of MDMA and other psychedelics," Brad Burge, communications director for MAPS, told The Huffington Post. "Now, the main challenge has become finding the funding necessary to complete the research. As these studies move forward, we'll start seeing support for psychedelic research as an opportunity, rather than a risk."
MAPS said that 18 patients diagnosed with life-threatening illnesses will undergo MDMA-assisted psychotherapy sessions under the supervision of Dr. Philip Wolfson, the study's principal investigator, at an office in Marin, California. The year-and-a-half study will test the drug's potential applications for treating anxiety and stress disorders related to the end of life. MAPS will begin recruiting subjects as soon as final preparations are made, hopefully within about two months, Burge said.
This is not a new area for Wolfson: The physician and psychologist prescribed MDMA legally for years as an aid in psychotherapy before it was banned by the federal government in 1985, said Burge. Wolfson also wrote a 1986 article in the Journal of Psychoactive Drugs championing the therapeutic uses of MDMA and the need for more research.
MAPS has sponsored several completed studies on the drug and is overseeing a handful of ongoing efforts, both in the U.S. and abroad. The previous studies have suggested that the feelings of euphoria and empathy also associated with MDMA's club-drug counterparts can make psychotherapy more effective.
"In a psychotherapeutic context, MDMA has been reported to help subjects lower their psychological defenses and enhance their ability to process difficult emotions," Burge said. "It may also increase the sense of trust between subjects and the therapist."
In 2010, a small U.S. study of MDMA-assisted psychotherapy in the treatment of PTSD found that 83 percent of those who had been treated while on the drug no longer showed symptoms of PTSD. The study was sponsored by MAPS. A follow-up study, published in 2012, found that most of those subjects remained symptom free and that none of them reported harm from the initial use of MDMA. The researchers said those results backed up their claim that MDMA-assisted psychotherapy can have lasting effects after just a handful of treatments.
Another small Swiss study, published in 2012 and also sponsored by MAPS, found MDMA to be less effective in treating PTSD, but similarly showed no serious adverse effects for the subjects.
The MAPS website states that pure MDMA has been proven "sufficiently" safe for human use when taken a limited number of times in moderate doses under medical supervision. MAPS is careful to distinguish between that and the much riskier street use of Molly and Ecstasy, two drugs that are often adulterated with other drugs and contaminants.
The latest trial is expected to cost about $587,000, according to MAPS, with just over half of that raised so far. The research is part of the group's $20 million effort to make MDMA a legal prescription medicine by 2021.