Phase 2
Completed N=12
Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults
Social Anxiety in Autistic Adults
Source: ClinicalTrials.gov NCT02008396 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Liebowitz Social Anxiety Scale (LSAS) Total Score 1-Month Post Experimental Session 2 — 34.3; 55.5; 64.0 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Liebowitz Social Anxiety Scale (LSAS) Total Score 1-Month Post Experimental Session 2 |
34.3; 55.5; 64.0 | — |
| PRIMARY Change in Leibowitz Social Anxiety Scale (LSAS) Total Score From Baseline to 1-Month Post Experimental Session 2 |
-51.0; -39.0; -19.3 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02008396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.