Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults
Status:
Completed
Trial end date:
2017-08-01
Target enrollment:
Participant gender:
Summary
This double-blind, randomized, placebo-controlled exploratory pilot study assessed the safety
and feasibility of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for social
anxiety in MDMA-naïve adults on the autism spectrum. Each of the 12 subjects participated in
two blinded experimental sessions, assisted by either MDMA (75 mg to 125 mg) or placebo,
which lasted seven hours. Before experimental sessions, participants underwent three separate
hour-long preparatory sessions to learn what to expect and complete pre-treatment
assignments. After each experimental session, participants underwent three separate hour-long
integrative sessions to help integrate their experiences and insights from the experimental
sessions.
Subjects assigned to the MDMA group received two of three different doses, either 75 mg, 100
mg, or 125 mg MDMA. Overall, eight subjects were randomized to the MDMA group and four
subjects were randomized to the placebo group. Observations before, during, and after
experimental sessions were compared between these groups.
The main objective of this study was to collect safety data to examine whether MDMA-assisted
therapy was tolerated and to estimate symptom reduction in social anxiety and other
psychiatric symptoms. The primary outcome measure was change in social anxiety symptoms as
measured by the Liebowitz Social Anxiety Scale (LSAS) [Heimberg et al., 1999].
Phase:
Phase 2
Details
Lead Sponsor:
Multidisciplinary Association for Psychedelic Studies
Collaborators:
Los Angeles Biomedical Research Institute Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center