The U.S. Drug Enforcement Administration (DEA) has approved the first clinical trial of MDMA to treat anxiety and other psychological illnesses, amid a growing resurgence in therapeutic psychedelic drug usage in the medical community.
“The tide has changed for psychedelic research,” said Brad Burge, the communications director for the Multidisciplinary Association for Psychedelic Studies (MAPS), a California-based nonprofit research group that studies medicinal uses for psychedelics and marijuana and is sponsoring the study. The DEA approved the project on Friday, he said.
Unlike Ecstasy or Molly — names for MDMA sold on the street and often mixed with dangerous adulterants — pure MDMA has been proved “sufficiently safe” when taken a limited number of times in moderate doses, MAPS says on its website. The DEA did not immediately respond to a request for comment.
MDMA can be useful in psychotherapy for people suffering from anxiety due to life-threatening illnesses because it produces in users a sense of calm, trust and confidence, Burge said. Unlike psychedelics such as LSD and psilocybin, MDMA does not produce hallucinations, he added.
The clinical trial will be held in Marin, California, in a psychologist’s office, as opposed to a hospital setting, Burge said. The patients will lie on a couch with a therapist nearby for support and conversation.
In the trial, 18 subjects diagnosed with life-threatening illnesses will attend months of psychotherapy, with MDMA being used in a few sessions in order to facilitate the process, he said. The outcome will be measured by whether using the psychedelic helps reduce people’s anxiety, which will be determined at the end of the sessions by the patient’s feedback and the therapist’s assessments.
Researchers hope that using MDMA alongside psychotherapy will let subjects confront their situation more clearly and allow the positive steps they take during the therapy to “stick,” Burge said.
“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.”
If the pilot is successful, MAPS plans to continue with further studies involving more subjects and different approaches. For now, researchers hope to establish basic safety and effectiveness, he said.
The trial is part of a larger $20 million plan to make MDMA an FDA-approved prescription medicine by 2021, Burge said. MAPS is the only organization in the world funding MDMA-assisted psychotherapy trials, he added. The institute has carried out successful pilot studies of MDMA-assisted psychotherapy for post-traumatic stress disorder, adding to the drug’s scientific credibility, he said. Other research by the institute includes ayahuasca-assisted therapy for drug addiction, LSD for cluster headaches and psilocybin for nicotine addiction.
Researchers hope to back up growing evidence that psychedelics have legitimate therapeutic uses — and to counter the narrative that has demonized them as mind-destroying drugs.
“That’s what the really good science shows, despite decades of propaganda and government misinformation,” Burge said. “Just a couple weeks ago, a phenomenal study showed that there are no long-term associations between psychedelic use and mental illnesses.”
That study was published this month in the Journal of Psychopharmacology. In addition, a recent report by Johns Hopkins Medicine, a leading U.S. medical institution combining the Johns Hopkins University School of Medicine and the Johns Hopkins Hospital, showed that the use of psychedelic drugs — primarily psilocybin and LSD — could reduce psychological distress and suicidal thinking.