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NCT02008396 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults
A Phase 2 study, sponsored by Resilient Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT02008396: Completed Phase 2 study, sponsored by Resilient Pharmaceuticals.
NCT02008396 is a Phase 2 study that has completed, run by Resilient Pharmaceuticals. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02008396, a Phase 2 study, has completed, sponsored by Resilient Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Placebo
- BEHAVIORAL Therapy
- DRUG Midomafetamine HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2014-04-11 |
| Est. Completion | 2017-04-28 |
| Phase | Phase 2 |
What the finished NCT02008396 record still lists
NCT02008396 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02008396 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02008396 about?
NCT02008396 is a clinical study titled "Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults". 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...
What is the current status of trial NCT02008396?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2014-04-11. Estimated completion is 2017-04-28.
What interventions are being tested in trial NCT02008396?
The interventions under investigation include: Placebo (DRUG), Therapy (BEHAVIORAL), Midomafetamine HCl (DRUG).
Who is sponsoring clinical trial NCT02008396?
This trial is sponsored by Resilient Pharmaceuticals, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02008396's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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