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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02008396
The ClinicalTrials.gov registry entry for NCT02008396 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Resilient Pharmaceuticals, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02008396 reports 0 study locations.
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.
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