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NCT01404754 · ClinicalTrials.gov registry record · Phase 1
Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers
A Phase 1 study, sponsored by Resilient Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 107
- Enrollment target
NCT01404754: Completed Phase 1 study, sponsored by Resilient Pharmaceuticals.
NCT01404754 is a Phase 1 study that has completed, run by Resilient Pharmaceuticals. The registered enrollment target is 107 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01404754, a Phase 1 study, has completed, sponsored by Resilient Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 107 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to study MDMA-assisted therapy in healthy volunteers. The main question it aims to answer is: Do two sessions of MDMA-assisted therapy result in changes in mood, emotional closeness to self and others, and other psychological symptoms? Researchers will compare MDMA-assisted therapy to placebo with therapy. Participants will have a non-drug preparatory session prior to each experimental session and an integrative session after each experimental session. Participants who received MDMA will crossover to receive placebo and placebo participants will crossover to receive MDMA.
Primary Outcome
Assesses current mood state
Interventions
- DRUG midomafetamine HCl
- DRUG Lactose (inactive placebo)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2011-04-09 |
| Est. Completion | 2022-08-05 |
| Phase | Phase 1 |
What the finished NCT01404754 record still lists
NCT01404754 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% higher).
The record links to 0 conditions, and to 2 interventions - of which midomafetamine HCl is the first listed.
NCT01404754 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01404754 about?
NCT01404754 is a clinical study titled "Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers". The goal of this clinical trial is to study MDMA-assisted therapy in healthy volunteers. The main question it aims to answer is: Do two sessions of MDMA-assisted therapy result in changes in mood, emotional closeness to self and others, and other psychological symptoms? Researchers will compare MD...
What is the current status of trial NCT01404754?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 107 participants. The study started on 2011-04-09. Estimated completion is 2022-08-05.
What interventions are being tested in trial NCT01404754?
The interventions under investigation include: midomafetamine HCl (DRUG), Lactose (inactive placebo) (DRUG).
Who is sponsoring clinical trial NCT01404754?
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 NCT01404754's enrollment target sits among peer trials
107 531st of 2000 higher than 1,470 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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