Abstract
RationaleStandard therapeutic approaches to reduce social anxiety in autistic adults have limited effectiveness. Since 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy shows promise as a treatment for other anxiety disorders, a blinded, placebo-controlled pilot study was conducted.ObjectivesTo explore feasibility and safety of MDMA-assisted psychotherapy for reduction of social fear and avoidance that are common in the autistic population.MethodsAutistic adults with marked to very severe social anxiety were randomized to receive MDMA (75 to 125 mg, n = 8) or inactive placebo (0 mg, n = 4) during two 8-h psychotherapy sessions (experimental sessions) in a controlled clinical setting. Double-blinded experimental sessions were spaced approximately 1 month apart with 3 non-drug psychotherapy sessions following each. The primary outcome was change in Leibowitz Social Anxiety Scale (LSAS) Total scores from Baseline to one month after the second experimental session. Outcomes were measured again six months after the last experimental session.ResultsImprovement in LSAS scores from baseline to the primary endpoint was significantly greater for MDMA group compared to the placebo group (P = 0.037), and placebo-subtracted Cohen’s d effect size was very large (d = 1.4, CI − 0.074, 2.874). Change in LSAS scores from baseline to 6-month follow-up showed similar positive results (P = 0.036), with a Cohen’s d effect size of 1.1 (CI − 0.307, 2.527). Social anxiety remained the same or continued to improve slightly for most participants in the MDMA group after completing the active treatment phase.ConclusionsThis pilot trial demonstrated rapid and durable improvement in social anxiety symptoms in autistic adults following MDMA-assisted psychotherapy. Initial safety and efficacy outcomes support expansion of research into larger samples to further investigate this novel treatment for social anxiety.Trial registrationclinicaltrials.gov identifier, NCT02008396
Highlights
In humans, 3,4-methylenedioxymethamphetamine (MDMA) generates feelings of social affiliation and increases social approach while diminishing negative responses to social rejection (Kamilar-Britt and Bedi 2015)
Initial safety and efficacy outcomes support expansion of research into larger samples to further investigate this novel treatment for social anxiety
Mean baseline BMI was greater in the placebo group than the MDMA group
Summary
3,4-methylenedioxymethamphetamine (MDMA) generates feelings of social affiliation and increases social approach while diminishing negative responses to social rejection (Kamilar-Britt and Bedi 2015). MDMA is primarily a potent releaser of serotonin and norepinephrine, and to a lesser extent dopamine (de la Torre et al 2004; Hysek and Liechti 2012). OT is associated with social affiliation in mammals and attenuates amygdalar response to anxiogenic stimuli (Adolphs et al 2005; Bartz and Hollander 2006), and OT receptor gene variations may modulate prosocial effects of MDMA in humans (Bershad et al 2016; Vizeli and Liechti 2018). Anticipating concerns about using a schedule 1 substance in a clinical trial with an autistic adult population, we published a preliminary paper on study rationale and methods including information on history, pharmacology, effects in animals and humans, safety, and clinical advantages of MDMA (Danforth et al 2016)
Sign-in/Register to view highlights & summary 
Published Version (
Free)
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call