Results published in Psychopharmacology
On September 8, 2018, the results of the first clinical trial of MDMA-assisted psychotherapy for the treatment of social anxiety were published in the peer-reviewed journal Psychopharmacology. All 12 participants in the small pilot study were adults on the autism spectrum, a population that commonly experiences severe social anxiety.
Sponsored by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), the study found significant and lasting reductions in social anxiety following two sessions of MDMA-assisted psychotherapy along with additional preparatory and integrative sessions without MDMA. The study
also demonstrated the safety of limited doses of MDMA in a controlled therapeutic setting. In this study, MDMA-assisted psychotherapy was not intended to treat autism itself, but rather for social anxiety in adults with autism.
The research was conducted by Charles Grob, M.D., and Alicia Danforth, Ph.D., at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, and conducted in cooperation with the U.S. Food and Drug Administration (FDA), Drug Enforcement Administration, and ethics boards.
The study found reductions in the social anxiety that were significantly greater for participants who received MDMA-assisted psychotherapy than for those who received placebo (psychotherapy without MDMA). On average, participants in the placebo group experienced reductions of 19.3 points on the Liebowitz Social Anxiety Scale (LSAS), compared to 44.1 reductions in the MDMA group.
“What was particularly notable for many of the participants after treatment was their increased self-confidence when interacting in social settings, an endeavor that in the past they had experienced as overwhelming,” said Dr. Grob. “We hope that our study will help to establish a foundation for future investigations exploring the safety and efficacy of MDMA in the treatment of social anxiety in vulnerable patient populations.”
The rationale for the trial came from doctoral survey research conducted by Alicia Danforth about the MDMA experiences of adults with autism. In the survey, 91% of participants reported “increased feelings of empathy/connectedness” and 86% experienced “ease of communication” after using MDMA (or “Ecstasy”) in non-clinical settings.
Similar to previous research for other conditions, the study indicated an acceptable risk profile for MDMA, with the most frequently reported adverse reactions during experimental sessions being anxiety and difficulty concentrating. Participants also reported fatigue, headaches, and sensitivity to cold. There were no unexpected serious adverse reactions. Temporary elevations in pulse, blood pressure, and temperature were also recorded during MDMA sessions, and did not require medical intervention.
“We hope that the good safety profile and encouraging reduction in social anxiety symptoms will inspire funding for new and larger studies,” said Dr. Danforth. “We are looking forward to sharing what we learned with other researchers and communities committed to improving the quality of care for autistic adults and other populations struggling with social anxiety.”
Participants reported reduced barriers to successful social interactions and increased confidence in school, at work, in friendships, and in romantic relationships following MDMA-assisted psychotherapy. “I felt like I was experiencing my best self and seeing the world for the first time and seeing myself for the first time,” reported one participant. Another said: “I realized communication is not just about talking. Now, I take time to notice my emotions and others’ emotions before talking.”
Autism refers to a spectrum of congenital and pervasive neurocognitive variants. Autistic individuals frequently experience difficulty in the realm of social interaction, often including social anxiety. There are currently no FDA-approved pharmacological treatments for adults with autism with social anxiety, and conventional anti-anxiety medications are often ineffective in this population.
The Psychopharmacology article was authored by Alicia L. Danforth, Ph.D., Charles S. Grob, M.D., Christopher Struble, M.D., Allison A. Feduccia, Ph.D., Nick Walker, Lisa Jerome, Ph.D., Berra Yazar-Klosinski, Ph.D., and Amy Emerson.
Goals for this study include (1) gathering evidence for the safety and effectiveness of MDMA-assisted therapy for adults with autism and diagnosed with social anxiety, (2) determining if additional studies in this area are warranted, and (3) initiating a new program of research into a possible beneficial use of MDMA building on collected case accounts.