Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00090064 · ClinicalTrials.gov registry record · Phase 2
MDMA-Assisted Psychotherapy in People With Posttraumatic Stress Disorder
A Phase 2 study of Post Traumatic Stress Disorder, sponsored by Lykos Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT00090064: Completed Phase 2 study of Post Traumatic Stress Disorder, sponsored by Lykos Therapeutics.
NCT00090064 is a Phase 2 study of Post Traumatic Stress Disorder that has completed, run by Lykos Therapeutics. The registered enrollment target is 23 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00090064, a Phase 2 study of Post Traumatic 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.
Primary Outcome
The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
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 |
What the finished NCT00090064 record still lists
NCT00090064 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 3 interventions - of which Therapy is the first listed.
NCT00090064 reports a single indexed study location in 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: Post Traumatic 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.
Learn More About Clinical Trials
Similar trials for Post Traumatic Stress Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00090064's enrollment target sits among peer trials
23 227th of 262 higher than 35 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder 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
-
Department of Defense PTSD Adaptive Platform Trial - Intervention A - Fluoxetine
RECRUITING · Phase 2
-
Facilitation of Extinction Retention and Reconsolidation Blockade by IV Allopregnanolone in PTSD.
RECRUITING · Phase 2
-
Facilitation of Extinction Retention and Reconsolidation Blockade in PTSD
RECRUITING · Phase 2
-
Department of Defense PTSD Adaptive Platform Trial - Master Protocol
RECRUITING · Phase 2
-
MDMA for AUD/PTSD Comorbidity
RECRUITING · Phase 2
-
Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol (R33)
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03616041 · 23 participants
Capsule Endoscopy for Severe Hematochezia
- NCT04348747 · 23 participants · Phase 2
Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer
- NCT04587687 · 23 participants · Phase 2
Brentuximab Vedotin and Bendamustine for the Treatment of Relapsed or Refractory Follicular Lymphoma
- NCT04715022 · 23 participants · Phase 1
Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance (Vitamin C Study)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI