First Clinical Trial: Social Anxiety in Autistic Adults Successfully Treated with MDMA Therapy

Learn about how MDMA for autism used with psychotherapy shows promise for relieving severe social anxiety experienced by autistic adults.
Featured Image: First Clinical Trial: Social Anxiety in Autistic Adults Successfully Treated with MDMA Therapy
Author: Allison Feduccia, PhD
By Allison Feduccia, PhD
September 13, 2018(Updated: April 5, 2021)

This week Psychopharmacology [1] published the first clinical trial in adults on the autism spectrum investigating MDMA, or any psychedelic substance for that matter. This groundbreaking research looked at whether MDMA combined with psychotherapy could help with severe social anxiety commonly experienced by autistic adults.

The drug-therapy combination wasn’t intended to be a treatment for autism itself. The combination was evaluated to see if it could possibly relieve some of the symptoms that limit social adaptability and often affect quality of life.

Marked Improvement with MDMA for Autism

Twelve study participants were given MDMA or placebo during two all-day therapy sessions. The clinical trial worked in tandem with additional non-drug preparatory and integrative therapy sessions. The main findings of this pilot study showed marked improvements in social anxiety and less avoidance of social interactions for the MDMA group. Most importantly, limited doses of MDMA in the controlled clinical setting were safe and well tolerated in adults on the autism spectrum.

91% of participants reported “increased feelings of empathy/connectedness” and 86% experienced “ease of communication” during MDMA/Ecstasy that persisted after use

The rationale for this double-blind study came after a review of accounts in online discussion forums. The unsolicited accounts shared detailed reports of MDMA/Ecstasy use by autistic adults in non-medical settings. The individuals using MDMA for autism suggested that some had better overall functioning and others had reduced symptoms of anxiety [2].

For her dissertation research, Dr. Alicia Danforth conducted interviews and collected survey data about the MDMA experiences of autistic adults. The survey found that 91% of participants reported “increased feelings of empathy/connectedness.” Moreover, 86% experienced “ease of communication” during MDMA/Ecstasy use that persisted afterwards.

MAPS Study

In 2014, these findings supported the Multidisciplinary Association for Psychedelic Studies (MAPS)’s commitment to sponsor a Phase 2 randomized, controlled trial of MDMA-assisted psychotherapy. Dr. Danforth and Dr. Charles Grob (a long-established researcher of psychedelic substances) led the trial at the Los Angeles BioMedical Research Institute at the Harbor-UCLA Medical Center. Danforth and Grob worked together as a co-therapy team for participants in MDMA-assisted psychotherapy.

The trial design followed similar methods used for MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). However, this trial included some variations to meet the specific needs of the autistic population. Dr. Danforth said, “This study was the first of its kind, and one of the success factors was working with autistic consultants from protocol development through writing the findings paper. As a result, the investigators had a well-supported rationale for focusing on social anxiety and were able to create a setting that would feel safe and comfortable for a population that often struggles with novel situations and sensory overstimulation.”

For example, the first four participants received MDMA in the initial session at a dose lower (75 mg) than the typical full dose in PTSD trials (100-125 mg). This assessed whether autistic participants experienced similar subjective effects that would constitute a therapeutic window without becoming overwhelmed. There were no issues with the 75 mg dose. Thus the dose was escalated to 100-125 mg for the rest of the sessions and participants.

Researchers also wove in mindfulness-based therapy. Why? Because this approach has previously been shown useful for autistic adults and other populations who struggle with emotion regulation, relationships, and distress tolerance. Whereas PTSD trials require the participant to stay overnight in the clinic after MDMA sessions, participants in this study would leave after the MDMA for autism session ended. A trusted Study Support Partner accompanied participants afterwards, and remained with them at home. This adaptation was made to best accommodate autistic adults who may have elevated anxiety from staying in a clinic setting overnight.

Leibowitz Social Anxiety Scale Results

The study employed the Leibowitz Social Anxiety Scale (LSAS) one month after the second experimental session (MDMA or placebo given during 8-hour psychotherapy sessions). LSAS is the primary measure for gauging social anxiety. The MDMA group showed significantly more improvement in social functioning. The same MDMA group also displayed less distress in social situations than the placebo group. The large therapeutic effects remained six-months later.

One individual said, “Being a participant in the study affected me in many ways. My self-esteem increased, my social anxiety decreased, love flooded in, my heart healed, and I’m more resilient” [1].

Change in LSAS Total Scores

Baseline to One Month Post Second MDMA/Placebo Session
LSAS evaluates impact of social anxiety on areas of a person’s life

Results went beyond just changes in study measure scores. Participants and their Study Support Partner reported tangible gains in both family and romantic relationships. This included two participants feeling confident enough to start dating for the first time. One participant described the effect. “I have been able to sustain flirtatious conversations for a longer time. In these conversations, I realized communication is not just about talking. Now, I take time to notice my emotions and others’ emotions before talking” [1].

Another two participants felt more at ease talking about and reflecting on gender identity. Overall participants were more adept and comfortable in interactions with friends, family, and the therapy team.

Long-lasting Effects of MDMA for Autism

The effects lasted long after the MDMA session. Results showed remarkable anxiety reductions in triggering situations, like entering a new social setting or speaking on the telephone. The investigators observed the “emergence of apparently intact latent social skills (e.g., ease of initiating and sustaining conversation) that manifested and became apparent to observers during experimental sessions with MDMA when participants relaxed” [1].

Dr. Lisa Jerome, one of the researchers on the team, elaborated on this idea about MDMA. She said, “These findings show that MDMA and psychotherapy can help people, maybe by giving people a whole new set of experiences with social interactions. MDMA isn’t giving people something they didn’t have already. It’s helping them use what they had all along.”

This pilot study succeeded in establishing that MDMA-assisted psychotherapy can be used safely in adults on the autism spectrum. It also demonstrated MDMA’s helpfulness in relieving severe social anxiety in this population. Dr. Danforth was asked if new trials would be started soon. “We hope that the good safety profile and encouraging reduction in social anxiety symptoms will inspire funding for new and larger studies. It remains to be seen how the mainstream autism science community will respond to the new data.”

Further Study Needed

Before FDA approval, more clinical trials are needed in a much larger sample of autistic adults. The initial findings are compelling to expand research into this novel approach. “We are looking forward to sharing what we learned with other researchers and communities who are committed to improving the quality of care for autistic adults and other populations who struggle with social anxiety” says Danforth.

Dr. Danforth strongly encourages autistic individuals to wait until more data is generated in clinical trials. “Wait until this type of therapy is more widely available in controlled settings with qualified therapists.” She concludes saying, “In the meantime, we saw an indication that mindfulness-based therapy can also improve social anxiety symptoms. That has certainly been the case in my private practice, where I also have to wait patiently until I can provide MDMA-assisted therapy outside of a clinical trial.”

Read the full text, open-access article here.

  1. Danforth, Alicia L., Charles S. Grob Christopher M. Struble, Allison A. Feduccia, Nick Walker, Lisa Jerome, Berra Yazar-Klosinski, and Amy Emerson. “Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: A randomized, double-blind, placebo-controlled pilot study.” Psychopharmacology (2018): 1-12.
  2. Danforth, Alicia L., Christopher M. Struble, Berra Yazar-Klosinski, and Charles S. Grob. “MDMA-assisted therapy: a new treatment model for social anxiety in autistic adults.” Progress in Neuro-Psychopharmacology and Biological Psychiatry 64 (2016): 237-249.
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Author: Allison Feduccia, PhD
Allison Feduccia, PhD
Allison (Alli) Feduccia, PhD is the Co-Founder of Psychedelic Support. She is a neuropharmacologist interested in advancing psychedelic research, medicinal use of psychedelics, and ceremonial practices that incorporate plant medicines. Dr. Feduccia has published over 30 peer reviewed articles in scientific journals on psychedelics and mental health from her research at UT Austin, UCSF, NIH, and MAPS. Connect with Dr Feduccia on Linkedin.

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