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

NCT02008396 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-06-05

Study results available
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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.

Conditions

  • Social Anxiety in Autistic Adults

Interventions

DRUG

Placebo

Subjects will receive capsules of lactose of identical appearance to MDMA capsules during each of two experimental sessions. Capsules will be administered along with therapy.

DRUG

Midomafetamine HCl

Participants in Group 1 receive 75 or 100 mg during the two experimental sessions and participants in Group 2 receive 100 or 125 mg during two experimental sessions.

BEHAVIORAL

Therapy

Therapy conducted throughout experimental sessions. Therapists will use a largely nondirective approach. There will be periods of structured and unstructured interactions. The structured interactions will be selected based on elements of therapeutic interventions that are currently in use in this population for the treatment of social anxiety.

Sponsors & Collaborators

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    collaborator OTHER

  • Lykos Therapeutics

    lead INDUSTRY

Principal Investigators

  • Charles S. Grob, MD · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-11
Primary Completion
2017-04-28
Completion
2017-04-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02008396 on ClinicalTrials.gov