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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Multidisciplinary Association for Psychedelic Studies
• Collaborators: Los Angeles Biomedical Research Institute; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Treatments: N-Methyl-3,4-methylenedioxyamphetamine

Criteria

Inclusion Criteria:

• Have a diagnosis of Autism Spectrum Disorder.

• Have social anxiety.

• Are at least 21 years old.

• Have completed two years of college-level education or comparable vocational training.

• Are willing to refrain from psychiatric medication for at least 5 half-lives plus a week prior to experimental session.

• Agree to follow all study-related instructions and restrictions, including restrictions on food, alcohol and caffeine consumption prior to experimental sessions.

• Are willing to commit to preparatory sessions, medication management, experimental sessions, follow-up sessions and to complete evaluation instruments.

• Agree not to use MDMA/ecstasy outside of study sessions during the study, including the follow up period.

• Are willing to be contacted on a daily basis for a week after each experimental session.

• Are willing to provide a contact that is willing and able to be reached by investigators, accompany the subject during some or all of the study visits, and complete study measures.

• Are willing to give blood samples.

• Are proficient in speaking and reading English. Subjects communicating with text-to-speech technology will also be permitted to enroll.

Exclusion Criteria:

• Upon review of medical or psychiatric history must not have any current or past diagnosis that would be considered a risk to participation in the study.

• Are abusing illegal drugs.

• Are not able to give adequate informed consent.

• Are not able to attend face-to-face visits or those who plan to move out of the area within the treatment period.

• Are pregnant or nursing, or if are able to bear children and do not practice an effective means of birth control.