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Study of the Effects of MDMA/Ecstasy on Water Regulation, Sleep, and Cognition.

NCT01053403 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2013-05-31

No results posted yet for this 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.

Conditions

  • MDMA Discontinuation Syndrome

Interventions

DRUG

3,4-methylenedioxymethamphetamine or Placebo

1.5mg/kg MDMA or matched Placebo administered during 2 inpatients stays. There are 2 dosing sessions and all subjects will receive MDMA at least one time.

Sponsors & Collaborators

  • California Pacific Medical Center Research Institute

    lead OTHER

Principal Investigators

  • John Mendelson, MD · CPMC Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-12-31
Completion
2011-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01053403 on ClinicalTrials.gov