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

NCT02008396 | Completed Phase 2 Results

• 1 other identifier: MAA-1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

MDMA; autism; social anxiety

Outcome Measures

Primary Outcomes (2)

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

  The LSAS is a 24-item, semi-structured interview on the severity of Social Anxiety Disorder. The LSAS separately assesses fear and avoidance of 24 social situations. The scale is divided into 2 subscales, 13 situations concerning performance anxiety, and 11 situations pertaining to social situations. The 24 items are first rated on a Likert Scale from 0 to 3 on fear felt during the situations, and then the same items are rated regarding avoidance of the situation. Combining the total scores for the Fear and Avoidance sections provides an overall score with a maximum of 144 points and a minimum of 0 points. The higher the score, the greater the anxiety symptoms. The overall scores are interpreted as: 55-65 is moderate, 65-80 is marked, 80-95 is severe, and greater than 95 is very severe social anxiety symptoms.

  1-Month Post Experimental Session 2

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

  The LSAS is a 24-item, semi-structured interview on the severity of Social Anxiety Disorder. The LSAS separately assesses fear and avoidance of 24 social situations. The scale is divided into 2 subscales, 13 situations concerning performance anxiety, and 11 situations pertaining to social situations. The 24 items are first rated on a Likert Scale from 0 to 3 on fear felt during the situations, and then the same items are rated regarding avoidance of the situation. Combining the total scores for the Fear and Avoidance sections provides an overall score with a maximum of 144 points and a minimum of 0 points. The higher the score, the greater the anxiety symptoms. The overall scores are interpreted as: 55-65 is moderate, 65-80 is marked, 80-95 is severe, and greater than 95 is very severe social anxiety symptoms.

  Baseline to 1-Month Post Experimental Session 2

Study Arms (3)

Inactive Placebo with Therapy

PLACEBO COMPARATOR

Participants will receive inactive placebo during two psychotherapy sessions lasting approximately 7 hours.

Drug: Placebo; Behavioral: Therapy

Group 1: MDMA-assisted therapy 75 mg/100mg

EXPERIMENTAL

Participants will receive 75 mg and 100 mg midomafetamine HCl during two sessions of MDMA-assisted therapy, respectively, lasting approximately 7 hours.

Drug: Midomafetamine HCl; Behavioral: Therapy

Group 2: MDMA-assisted therapy 100 mg/125 mg

EXPERIMENTAL

Participants will receive 100 mg and 125 mg midomafetamine HCl during two sessions of MDMA-assisted therapy, respectively, lasting approximately 7 hours.

Drug: Midomafetamine HCl; Behavioral: Therapy

Interventions

Placebo DRUG

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.

Also known as: Inactive placebo

Inactive Placebo with Therapy

Midomafetamine HCl DRUG

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.

Also known as: 3,4-methylenedioxymethamphetamine, MDMA

Group 1: MDMA-assisted therapy 75 mg/100mg; Group 2: MDMA-assisted therapy 100 mg/125 mg

Therapy BEHAVIORAL

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.

Also known as: Manualized therapy

Group 1: MDMA-assisted therapy 75 mg/100mg; Group 2: MDMA-assisted therapy 100 mg/125 mg; Inactive Placebo with Therapy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Lykos Therapeutics: lead
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: collaborator

Study Sites (1)

Los Angeles Biomedical Research Institute

Torrance, California, 90502, United States

Location

Related Publications (3)

• Heimberg RG, Horner KJ, Juster HR, Safren SA, Brown EJ, Schneier FR, Liebowitz MR. Psychometric properties of the Liebowitz Social Anxiety Scale. Psychol Med. 1999 Jan;29(1):199-212. doi: 10.1017/s0033291798007879.

  PMID: 10077308 BACKGROUND

• Danforth AL, Grob CS, Struble C, Feduccia AA, Walker N, Jerome L, Yazar-Klosinski B, Emerson A. Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: a randomized, double-blind, placebo-controlled pilot study. Psychopharmacology (Berl). 2018 Nov;235(11):3137-3148. doi: 10.1007/s00213-018-5010-9. Epub 2018 Sep 8.

  PMID: 30196397 RESULT

• Danforth AL, Struble CM, Yazar-Klosinski B, Grob CS. MDMA-assisted therapy: A new treatment model for social anxiety in autistic adults. Prog Neuropsychopharmacol Biol Psychiatry. 2016 Jan 4;64:237-49. doi: 10.1016/j.pnpbp.2015.03.011. Epub 2015 Mar 25.

  PMID: 25818246 DERIVED

Related Links

• Link to open access copy of publication on study

MeSH Terms

Conditions

Autistic Disorder

Interventions

N-Methyl-3,4-methylenedioxyamphetamine; Therapeutics

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Lykos Therapeutics

trialdata@lykospbc.com

877-627-7722

Study Officials

• Charles S. Grob, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2013
• First Posted: December 11, 2013
• Study Start: April 11, 2014
• Primary Completion: April 28, 2017
• Study Completion: April 28, 2017
• Last Updated: June 5, 2025
• Results First Posted: October 14, 2020

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data and study-related documents will be available when all participants have completed the study
• Access Criteria: Interested persons should correspond with the central contact for the study.

Locations

US (1)