Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults

Completed · Phase 2 · Has a placebo group

Conditions studied: Social Anxiety in Autistic Adults

In brief

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective at reducing social anxiety in adults with autism. The main questions it aims to answer are: * Do two sessions of MDMA-assisted therapy reduce social anxiety? * What dose of MDMA is most effective at reducing social anxiety? Researchers will compare two blinded sessions of MDMA-assisted therapy to two blinded sessions of placebo with therapy. Participants will undergo three non-drug preparatory therapy sessions before the first blinded medication session. After each medication session, participants will undergo three non-drug integrative therapy sessions. In Stage 2, participants who received placebo with therapy in the first two blinded sessions will be able to undergo two sessions with MDMA-assisted therapy.

Key facts

Study ID

NCT02008396

Run by

Resilient Pharmaceuticals

People needed

12

Starts

2014-04-11

Expected to finish

2017-04-28

Last updated by the study team

2025-06-05

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Los Angeles Biomedical Research Institute — Torrance, California, United States

Full record on ClinicalTrials.gov

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