Clinical trials studying the effects of MDMA on patients suffering from anxiety caused by life-threatening illnesses are set to begin just months after the U.S. Drug Enforcement Administration (DEA) approved testing of the drug.

MDMA (3,4-methylenedioxy-methamphetamine), or more commonly known as ecstasy or molly, is a synthetic, psychoactive drug that produces feelings of euphoria. It was created in the early 1900s and used as a psychotherapeutic tool, but the drug never received approval from the U.S. Food and Drug Administration.

Nevertheless, during the late 1970s and early 1980s, MDMA began cropping up on the street, and in 1985, the DEA banned the drug, classifying it as a Schedule I drug along with other substances considered to have no therapeutic value.


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Today, however, the DEA is granting MDMA a second chance. According to the Multidisciplinary Association for Psychedelic Studies (MAPS), pure MDMA, unlike forms of the drug sold on the street, which are often mixed with dangerous adulterants, is “sufficiently safe” when taken in moderate doses.

In fact, communications director for MAPS, Brad Burge, says MDMA can have positive effects during psychotherapy on people suffering from life-threatening illnesses because it gives users a sense of calm, trust, and confidence.

The study will evaluate at least 12 patients diagnosed with life-threatening illnesses as they attend two separate psychotherapy sessions, spaced about one month apart over the next year. Each patient will be randomly given either a full dose of MDMA (125 milligrams) or an active placebo dose of 30 milligrams. The outcome of the study will be measured by whether or not the drug helps reduce the patients’ anxiety, which will be determined by their feedback and the therapist’s assessments.

Results of the study are expected within 12 to 15 months.

The hope is that MDMA will help the terminally ill patients to come to terms with their illnesses.

“It opens them up and makes them more comfortable with the therapist while reducing fear and making them more able to talk about difficult emotions,” Burge said.    

If the trial is successful, MAPS will move on to further studies involving more patients and different approaches.

“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,” Burge added. “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.”

The study isn’t the first of its kind. In 2010, a MAPS-sponsored study found that 83% of patients with post-traumatic stress disorder no longer showed symptoms of PTSD while on MDMA. A follow-up study published in 2012 found that most of those same patients remained symptom-free. The results backed the claim that MDMA-assisted psychotherapy can provide lasting effects even after just a few treatments.

The latest research is part of MAPS’ $20 million effort to make MDMA a legal prescription medicine by 2021.

Reference

  1. A brief history of MDMA. National Institute on Drug Abuse website. http://www.drugabuse.gov/publications/mdma-ecstasy-abuse/brief-history-mdma.
  2. Lewis R. DEA approves study using MDMA for anxiety in seriously ill patients. Al Jazeera website. March 17, 2015. http://america.aljazeera.com/articles/2015/3/17/clinical-trial-approved-for-mdma-psychotherapy.html.
  3. Pandey A. Ecstasy being studied as anti-anxiety medicine for terminally ill and autistic patients. International Business Times website. May 27, 2015. http://www.ibtimes.com/ecstasy-being-studied-anti-anxiety-medicine-terminally-ill-autistic-patients-1939575.
  4. Wing N. DEA approves study of psychedelic drug MDMA in treatment of seriously ill patients. The Huffington Post website. March 18, 2015. http://www.huffingtonpost.com/2015/03/18/dea-mdma-study_n_6888972.html.