Clinical TrialAnxiety DisordersPlaceboMDMAMDMACompleted

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

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.

Target Enrollment
12 participants
Study Type
Phase II interventional
Design
Randomized, triple Blind

Detailed Description

Randomized, triple-masked, parallel-group Phase II pilot (n=12) comparing two blinded MDMA-assisted therapy sessions to two blinded placebo-with-therapy sessions in autistic adults with social anxiety; therapy included three 1-h preparatory sessions and three 1-h integrative sessions after each experimental session.

Dose-escalation design: Group 1 received 75 mg then 100 mg; Group 2 received 100 mg then 125 mg; placebo arm received lactose capsules identical in appearance. Primary outcome: change in LSAS social anxiety score; safety/tolerability assessed throughout and blind maintained through six-month follow-up.

Study Protocol

Preparation

3 sessions
60 min each

Dosing

2 sessions
420 min each

Integration

6 sessions
60 min each

Therapeutic Protocol

support

Study Arms & Interventions

Placebo + Therapy

inactive

Inactive lactose placebo capsules administered with manualised/nondirective therapy in two blinded 7-hour sessions.

Interventions

  • Placebo
    via Oral• two sessions• 2 doses total

    Lactose capsules identical in appearance to MDMA; given during each experimental session.

  • Compound
    via Other• throughout sessions

    Manualised, largely nondirective psychotherapy: three 1-h preparatory sessions and three 1-h integrative sessions per experimental session.

Group 1 MDMA

experimental

MDMA-assisted therapy with dose escalation: 75 mg in session 1, 100 mg in session 2 (unless contraindicated).

Interventions

  • MDMA75 - 100 mg
    via Oral• two sessions• 2 doses total

    Session 1: 75 mg; Session 2 (~1 month later): 100 mg if tolerated.

  • Compound
    via Other• throughout sessions

    Therapy as per manualised nondirective approach; preparatory and integrative sessions included.

Group 2 MDMA

experimental

MDMA-assisted therapy with dose escalation: 100 mg in session 1, 125 mg in session 2 (unless contraindicated).

Interventions

  • MDMA100 - 125 mg
    via Oral• two sessions• 2 doses total

    Session 1: 100 mg; Session 2 (~1 month later): 125 mg if tolerated.

  • Compound
    via Other• throughout sessions

    Therapy as per manualised nondirective approach; preparatory and integrative sessions included.

Participants

Ages
21 – 99
Sexes
Male & Female

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.

Study Details

  • Status
    Completed
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment12 participants
  • Timeline
    Start: 2014-01-02
    End: 2017-01-08
  • Compounds
    PlaceboMDMAMDMA
  • Topic
    Anxiety Disorders

Locations

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

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