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CompletedPhase 2Results posted

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

NCT02008396 · Resilient Pharmaceuticals

Closed to entry
Status
Not accepting participants
Phase 2
Phase
12
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Liebowitz Social Anxiety Scale (LSAS) Total Score 1-Month Post Experimental Session 2

    Measured over 1-Month Post Experimental Session 2

  • Change in Leibowitz Social Anxiety Scale (LSAS) Total Score From Baseline to 1-Month Post Experimental Session 2

    Measured over Baseline to 1-Month Post Experimental Session 2

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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.

Where

1 study site

FacilityCityRegionCountry
Los Angeles Biomedical Research InstituteTorranceCaliforniaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT02008396 on ClinicalTrials.gov →

Last updated in the registry 2025-06-05. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits