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NCT01053403 · ClinicalTrials.gov registry record · NA
Study of the Effects of MDMA/Ecstasy on Water Regulation, Sleep, and Cognition.
A NA study, sponsored by California Pacific Medical Center Research Institute.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT01053403 is a NA study that has completed, run by California Pacific Medical Center Research Institute. The registered enrollment target is 12 participants.
The verdict
NCT01053403, a NA study, has completed, sponsored by California Pacific Medical Center Research Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study is to measure the effects of MDMA on sleep, mood, thinking, and how your body retains water. The researchers are interested in the effects that occur a few hours after taking MDMA as well as effects occurring over the next two days. We will study these effects in a standardized, controlled setting at the Clinical and Translational Science Institute (CTSI) Clinical Research Center (CRC) located at San Francisco General Hospital. The primary hypotheses are: 1. MDMA will induce sleep disruption, as indicated by comprehensive polysomnography, wrist actigraphy, and self-report sleep measures 2. MDMA will alter sodium and water homeostasis by either increasing or blunting the suppression of arginine vasopressin levels and decreasing free water excretion. Effects will be exacerbated by water loading. Secondary hypotheses: 1. Acutely, MDMA will increase both positive and negative arousal, and to increase sociability but not autonomy. 2. Acutely, MDMA will increase risk-taking and willingness to donate money to others in an economic decision making task. 3. MDMA will decrease the stressful effects of talking about a negatively-valenced autobiographical but will increase recall for details for these episodes. 4. MDMA will increase oxidative stress markers and possible ameliorating factors (e.g., ADMA). 5. The short form of the serotonin transported promoter region will be associated with greater acute and discontinuation effects of MDMA.
Interventions
- DRUG 3,4-methylenedioxymethamphetamine or Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2010-04 |
| Est. Completion | 2011-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01053403
The ClinicalTrials.gov registry entry for NCT01053403 describes a study currently listed as completed, categorized as NA. 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 California Pacific Medical Center Research Institute, which has 29 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 3,4-methylenedioxymethamphetamine or Placebo is the first listed.
NCT01053403 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01053403 about?
NCT01053403 is a clinical study titled "Study of the Effects of MDMA/Ecstasy on Water Regulation, Sleep, and Cognition.". The purpose of this study is to measure the effects of MDMA on sleep, mood, thinking, and how your body retains water. The researchers are interested in the effects that occur a few hours after taking MDMA as well as effects occurring over the next two days. We will study these effects in a standard...
What is the current status of trial NCT01053403?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2010-04. Estimated completion is 2011-02.
What interventions are being tested in trial NCT01053403?
The interventions under investigation include: 3,4-methylenedioxymethamphetamine or Placebo (DRUG).
Who is sponsoring clinical trial NCT01053403?
This trial is sponsored by California Pacific Medical Center Research Institute, which has 29 total clinical trials registered on ClinicalTrials.gov.
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