MDMA, the illicit drug that gives users an intense, high-energy euphoria, will soon be used for something much more serious than fueling all-night dance parties and music festival benders. After receiving DEA and FDA approval, researchers in California are ready to begin a clinical study to test whether the drug, also known as ecstasy or molly, can ease anxiety and depression in people with terminal illnesses such as cancer.
Dr. Philip Wolfson, a psychiatrist and longtime advocate of MDMA-assisted psychotherapy, is currently recruiting 18 people for a research project backed by the Multidisciplinary Association for Psychedelic studies (MAPS), according to the San Francisco Chronicle. Wolfson told the newspaper that when MDMA is administered in a safe environment, it can be "transformationally potent."
The trial will involve patients with a life expectancy of at least of nine months or longer, and employ double-blind testing that gives 125 milligram doses of MDMA to some participants and a placebo to others.
The idea behind the study is to see whether the drug can alleviate the disease-induced fear and depression experienced by people nearing death. Before it was prohibited by the Drug Enforcement Agency, MDMA was used as an aid to therapy by American psychologists in the 1970s and 1980s, leading it to be dubbed "penicillin for the soul."
Research in more recent years has suggested it can alleviate the symptoms of depression and post-traumatic stress disorder (PTSD). A previous MAPS study on victims of sexual abuse and Iraq War veterans found that 83 percent of subjects no longer met the criteria for PTSD after receiving MDMA-assisted therapy.
According to researchers, the MDMA "[decreased] levels of fear and defensiveness and increases trust between patient and practitioner when used in a clinical setting."
As reported by the San Francisco Chronicle, MDMA-assisted therapy is a deeply personal cause for Wolfson. In the 1980s, a therapist administered the drug to the doctor and his then wife while their son struggled with leukemia.
MAPS spokesman Brad Burge said the aim of this pilot study was to evaluate safety and initial efficacy, and if results were promising enough they would pursue a larger study on more patients.
After taking their dose — real or placebo — patients will participate in three eight-hour psychotherapy sessions, then undergo follow-up testing and counseling in subsequent months. The patients will be given the option to ingest an additional 62.5 milligrams of the drug to prolong the therapy session. They will also receive separate therapy without MDMA before and after they take the drug. Results are expected in the next 12 to 15 months.
"It's a substance that supports deep, meaningful and rapidly effective psychotherapy," Wolfson reportedly said.
MAPS said the DEA, which controls the use of MDMA and other illegal drugs in scientific research, had given the greenlight for the study, issuing licenses for the MDMA research.
Eventually, MAPS hopes to receive approval from the FDA to make ecstasy a prescription medicine. The US made MDMA a Schedule I controlled substance in 1985, a classification that means the drug has a high potential for abuse and no currently accepted medical use.
"If a drug works for a disabling condition and can be labeled to be used in a safe way in that population, then we think we have an obligation to evaluate the data and do what the data support, such as allow a trial to proceed," FDA spokeswoman Sandy Walsh said, according to the Chronicle.
If all goes according to plan, MAPS hopes that MDMA could also potentially be used on patients with PTSD and perhaps other conditions.
"When it's approved for PTSD in the US physicians, psychologists, and therapists will be able to administer MDMA off-label as well," Burge said. "The purpose of the [current] study is just so we have knowledge of whether it works."
Follow Kayla Ruble on Twitter: @RubleKB