Study of the Effects of MDMA/Ecstasy on Water Regulation, Sleep, and Cognition. (2C)
|ClinicalTrials.gov Identifier: NCT01053403|
Recruitment Status : Completed
First Posted : January 21, 2010
Last Update Posted : May 31, 2013
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:
- MDMA will induce sleep disruption, as indicated by comprehensive polysomnography, wrist actigraphy, and self-report sleep measures
- 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.
- Acutely, MDMA will increase both positive and negative arousal, and to increase sociability but not autonomy.
- Acutely, MDMA will increase risk-taking and willingness to donate money to others in an economic decision making task.
- MDMA will decrease the stressful effects of talking about a negatively-valenced autobiographical but will increase recall for details for these episodes.
- MDMA will increase oxidative stress markers and possible ameliorating factors (e.g., ADMA).
- The short form of the serotonin transported promoter region will be associated with greater acute and discontinuation effects of MDMA.
|Condition or disease||Intervention/treatment||Phase|
|MDMA Discontinuation Syndrome||Drug: 3,4-methylenedioxymethamphetamine or Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effects of MDMA on Sleep Architecture, Water Homeostasis and Cognitive Function|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||February 2011|
|Active Comparator: MDMA||
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.
Other Name: Ecstasy
- Time course, severity, and characteristics of MDMA discontinuation in experienced MDMA users given a known dose of MDMA [ Time Frame: 1 hour post dose through 48 hours post dose ]
- Relate observed discontinuation effects to sleep data: polysomnography, wrist actigraphy, and self-report sleep measures. [ Time Frame: 1 hour post dose through 48 hours post dose ]
- Assess the acute effects of MDMA on water and sodium homeostasis [ Time Frame: 1 hour post dose through 48 hours post dose ]
- Document the acute effects of MDMA on self-reported measures, including positive and negative arousal, autonomy, and sociability. [ Time Frame: 1 hour post dose through 48 hours post dose ]
- Document the acute effects of MDMA on behavioral measures of economic decision making. [ Time Frame: 1 hour post dose through 48 hours post dose ]
- Document the acute effects of MDMA on autobiographical speech and memory [ Time Frame: 1 hour post dose through 48 hours post dose ]
- Measure the effects of MDMA on ADMA [ Time Frame: 1 hour post dose through 48 hours post dose ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053403
|United States, California|
|CPMC Addiction & Pharmacology Research Laboratory (APRL)|
|San Francisco, California, United States, 94110|
|Principal Investigator:||John Mendelson, MD||CPMC Research Institute|