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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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Interventions

  • DRUG midomafetamine HCl
  • DRUG Lactose (inactive placebo)

Trial Details

FieldValue
Enrollment Target 107 participants
Start Date 2011-04-09
Est. Completion 2022-08-05
Phase Phase 1

Sponsor

Resilient Pharmaceuticals

17 total trials

What the Registry Record Tells You About NCT01404754

The ClinicalTrials.gov registry entry for NCT01404754 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 107 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 2 interventions - of which midomafetamine HCl is the first listed.

NCT01404754 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.