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NCT00090064 · ClinicalTrials.gov registry record · Phase 2
MDMA-Assisted Psychotherapy in People With Posttraumatic Stress Disorder
A Phase 2 study of Posttraumatic Stress Disorder, sponsored by Lykos Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT00090064 is a Phase 2 study of Posttraumatic Stress Disorder that has completed, run by Lykos Therapeutics. The registered enrollment target is 23 participants, below the 112-participant average among 117 other Posttraumatic Stress Disorder trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00090064, a Phase 2 study of Posttraumatic Stress Disorder, has completed, sponsored by Lykos Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to compare MDMA-assisted therapy to placebo with therapy in people with chronic, treatment-resistant posttraumatic stress disorder (PTSD). The main question it aims to answer is: Is there a reduction in PTSD symptoms among people given MDMA-assisted therapy compared to placebo with therapy? Participants will receive either MDMA-assisted therapy or placebo with therapy during two blinded experimental sessions spaced three to five weeks apart. During experimental sessions, participants receive an initial dose of 125 mg of MDMA HCl, or placebo, followed by a dose of 62.5 mg of MDMA HCl, or placebo. During this treatment period, participants will also undergo non-drug preparatory psychotherapy sessions and non-drug integrative sessions. The study will test whether MDMA-assisted therapy can be safely given to participants. Researchers will compare PTSD symptoms in the MDMA-assisted therapy group to the placebo with therapy group to see if there is a reduction in symptoms after the treatment period.
Conditions Studied
Interventions
- BEHAVIORAL Therapy
- DRUG Midomafetamine HCl
- DRUG Lactose placebo pill
Study Locations (1)
South Carolina
- Offices of Michael Mithoefer MD - Mt. Pleasant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2004-03-12 |
| Est. Completion | 2010-06-21 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00090064
The ClinicalTrials.gov registry entry for NCT00090064 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 112-participant average among 117 other Posttraumatic Stress Disorder trials with a reported enrollment target (79% lower). The listed sponsor is Lykos Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Posttraumatic Stress Disorder appearing as the primary indexed condition, and to 3 interventions - of which Therapy is the first listed.
NCT00090064 reports 1 study location spanning 1 distinct geographic area - top geographies include South Carolina.
Frequently Asked Questions
What is clinical trial NCT00090064 about?
NCT00090064 is a clinical study titled "MDMA-Assisted Psychotherapy in People With Posttraumatic Stress Disorder". The goal of this clinical trial is to compare MDMA-assisted therapy to placebo with therapy in people with chronic, treatment-resistant posttraumatic stress disorder (PTSD). The main question it aims to answer is: Is there a reduction in PTSD symptoms among people given MDMA-assisted therapy compare...
What is the current status of trial NCT00090064?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2004-03-12. Estimated completion is 2010-06-21.
What conditions does trial NCT00090064 study?
This clinical trial studies the following conditions: Posttraumatic Stress Disorder.
What interventions are being tested in trial NCT00090064?
The interventions under investigation include: Therapy (BEHAVIORAL), Midomafetamine HCl (DRUG), Lactose placebo pill (DRUG).
Who is sponsoring clinical trial NCT00090064?
This trial is sponsored by Lykos Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00090064 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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