Advertisement

Topics

The Effects of Methylenedioxymethamphetamine (MDMA) on Sleep Architecture, Water Homeostasis and Cognitive Function

2014-08-27 03:16:28 | BioPortfolio

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.

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Conditions

MDMA Discontinuation Syndrome

Intervention

3,4-methylenedioxymethamphetamine or Placebo

Location

CPMC Addiction & Pharmacology Research Laboratory (APRL)
San Francisco
California
United States
94110

Status

Recruiting

Source

California Pacific Medical Center Research Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:28-0400

Clinical Trials [1329 Associated Clinical Trials listed on BioPortfolio]

Interaction Between Duloxetine and 3,4-Methylenedioxymethamphetamine (MDMA, Ecstasy)

The purpose of this study is to determinate the effect of a pre-treatment with the combined serotonin (5-HT) and norepinephrine (NE) transport blocker duloxetine on the pharmacodynamics an...

Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)

MDMA (3,4-Methylenedioxymethamphetamine, "Ecstasy") produces tachycardia, hypertension, hyperthermia, and other acute adverse effects. Ecstasy use has also been associated with rare cardio...

A Test of MDMA-Assisted Psychotherapy in People With Posttraumatic Stress Disorder

This study is being conducted to find out if methylenedioxymethamphetamine (MDMA)-assisted psychotherapy is safe and can help people with posttraumatic stress disorder (PTSD) arising from ...

MDMA-assisted Therapy for Social Anxiety in Autistic Adults

This randomized, double-blind study is intended to test the safety and feasibility of using 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy, compared with placebo, to treat socia...

Effect of Methylenedioxymethamphetamine (MDMA) (Serotonin Release) on Fear Extinction

Serotonin and oxytocin play a role in fear conditioning and fear extinction learning, psychological processes that are critically involved in psychiatric disorders such as posttraumatic st...

PubMed Articles [5692 Associated PubMed Articles listed on BioPortfolio]

"Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: a randomized, double-blind, placebo-controlled pilot study".

Standard therapeutic approaches to reduce social anxiety in autistic adults have limited effectiveness. Since 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy shows promise as a treatme...

Dopamine and serotonin antagonists fail to alter the discriminative stimulus properties of ±methylenedioxymethamphetamine.

Most studies on discriminative stimulus effects of 3,4-methylenedioxymethamphetamine (MDMA) have been conducted using a relatively low dose (1.5 mg/kg), and those studies have invariably implicated ...

3,4-methylenedioxymethamphetamine (MDMA) alters synaptic dopamine release in the dorsal striatum through nicotinic receptors and DAT inhibition.

An increase of extracellular dopamine (DA) has been implicated in the psychostimulant properties of 3,4-methylenedioxymethamphetamine (MDMA). Although this drug has been reported to affect the DA upta...

Oxytocin receptor gene variations and socio-emotional effects of MDMA: A pooled analysis of controlled studies in healthy subjects.

Methylenedioxymethamphetamine (MDMA) increases oxytocin, empathy, and prosociality. Oxytocin plays a critical role in emotion processing and social behavior and has been shown to mediate the prosocial...

MDMA toxicity: management of acute and life-threatening presentations.

Since the 1980s, methylenedioxymethamphetamine (MDMA) has been a popular recreational drug, used particularly among those who attend raves and nightclubs. Over the past 3 years, the popularity of this...

Medical and Biotech [MESH] Definitions

Drugs designed and synthesized, often for illegal street use, by modification of existing drug structures (e.g., amphetamines). Of special interest are MPTP (a reverse ester of meperidine), MDA (3,4-methylenedioxyamphetamine), and MDMA (3,4-methylenedioxymethamphetamine). Many drugs act on the aminergic system, the physiologically active biogenic amines.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

Discontinuation of the habit of smoking, the inhaling and exhaling of tobacco smoke.

An N-substituted amphetamine analog. It is a widely abused drug classified as a hallucinogen and causes marked, long-lasting changes in brain serotonergic systems. It is commonly referred to as MDMA or ecstasy.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

More From BioPortfolio on "The Effects of Methylenedioxymethamphetamine (MDMA) on Sleep Architecture, Water Homeostasis and Cognitive Function"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Sleep Disorders
Sleep disorders disrupt sleep during the night, or cause sleepiness during the day, caused by physiological or psychological factors. The common ones include snoring and sleep apnea, insomnia, parasomnias, sleep paralysis, restless legs syndrome, circa...

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Alzheimer's Disease
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase  'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...


Searches Linking to this Trial