Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-30 @ 3:44 AM
Study NCT ID:
NCT01053403
Status:
COMPLETED
Last Update Posted:
2013-05-31
First Post:
2010-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Effects of MDMA/Ecstasy on Water Regulation, Sleep, and Cognition.
Sponsor:
California Pacific Medical Center Research Institute
Organization:
Study Overview
Official Title:
The Effects of MDMA on Sleep Architecture, Water Homeostasis and Cognitive Function
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
2C
Brief 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.
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.
Detailed Description:
This is a placebo-controlled, double-blind, gender balanced, within-subject study on the acute and 24 to 48 hour post dose effects (discontinuation syndrome) of MDMA on sleep architecture, water homeostasis and neurocognitive function. We will define the signs and symptoms of sleep disruption and time course of alterations in ADH levels and neurocognitive function occurring after administration of a single dose of MDMA in experienced users. The immediate effects of MDMA include euphoria and intoxication; at 24 hours after MDMA these positive effects are replaced by lowered mood and lethargy - we refer to these effects as a discontinuation syndrome. The pleasurable effects of MDMA are thought to be due to elevations of serotonin, norepinephrine and dopamine; the mechanisms of post-MDMA depression are unknown but may be due to relative serotonin depletion. Among its many functions serotonin maintains normal sleep architecture. The effects of MDMA discontinuation on sleep architecture will be assessed using comprehensive polysomnography and wrist actigraphy with measures obtained \~36 hours after a single dose of MDMA. Cognitive measurements will explore the acute effects of MDMA. MDMA can produce hyponatremia. In this study we will evaluate the effects of MDMA on ADH release, urine sodium excretion, and the relationship of gender to these effects.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5-R01-DA016776 (NIH) | None | None | View | |
| 5R01DA016776 | NIH | None | https://reporter.nih.gov/quic… | View |