Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of the Effects of MDMA/Ecstasy on Water Regulation, Sleep, and Cognition. (2C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01053403
Recruitment Status : Completed
First Posted : January 21, 2010
Last Update Posted : May 31, 2013
Sponsor:
Information provided by (Responsible Party):
John Mendelson, MD, California Pacific Medical Center Research Institute

Tracking Information
First Submitted Date  ICMJE January 8, 2010
First Posted Date  ICMJE January 21, 2010
Last Update Posted Date May 31, 2013
Study Start Date  ICMJE April 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2010)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Effects of MDMA/Ecstasy on Water Regulation, Sleep, and Cognition.
Official Title  ICMJE The Effects of MDMA on Sleep Architecture, Water Homeostasis and Cognitive Function
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE MDMA Discontinuation Syndrome
Intervention  ICMJE 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
Study Arms  ICMJE Active Comparator: MDMA
Intervention: Drug: 3,4-methylenedioxymethamphetamine or Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2010)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy men or women aged 18 to 50 years.
  • If female: abstains from heterosexual sex, not of childbearing potential, or reports using an approved contraceptive.
  • Experienced with MDMA
  • Fluent in English.
  • Willing and able to give written consent.
  • Healthy without medical contraindications to MDMA administration determined by the following: medical history, physical examination, 12-lead EKG, hematology, blood chemistry, and urinalysis.
  • Blood liver transaminase elevations up to 3 times the upper limit of normal.
  • If female: negative pregnancy test at screening and at the beginning of each hospital admission.
  • Negative urine drug test at screening and prior to each potential MDMA administration.

Exclusion Criteria:

  • Current enrollment in a MDMA, alcohol, or other drug treatment program or current legal problems relating to MDMA, alcohol, or other drug use, including awaiting trial or supervision by a parole or probation officer.
  • Participants with a past-history of using only low doses of MDMA
  • Currently trying to quit MDMA use.
  • Current dependence on any other psychoactive drug (including nicotine).
  • Significant physical or psychiatric illness that might impair the ability to safely complete the study or that might be complicated by the study drugs, including prior seizures (after age 8) or other active neurological disease or clinically significant abnormalities on physical examination or screening laboratory values.
  • Likelihood of needing medications to treat an illness during the study period.
  • Body Mass Index > 30 or < 18.
  • HIV seropositive by self-report.
  • If female: pregnancy or lactation.
  • History of serious adverse event or hypersensitivity to MDMA.
  • Currently taking any medication other than over-the-counter non-steroidal anti-inflammatories, topical medications, inhaled asthma therapy, and over-the-counter non-sedating antihistamines.
  • Male neck size ≥ 17 inches, female neck size ≥ 16 inches
  • Modified Mallampati class ≥ 3.
  • Recent travel within 3 days to or from a different time zone, other than Mountain Standard Time.
  • Any other medical or psychosocial condition that would preclude useful, safe, or consistent participation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01053403
Other Study ID Numbers  ICMJE IRB# 2009.099-1 (JMen)
5-R01-DA016776 (NIH)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Mendelson, MD, California Pacific Medical Center Research Institute
Study Sponsor  ICMJE California Pacific Medical Center Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John Mendelson, MD CPMC Research Institute
PRS Account California Pacific Medical Center Research Institute
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP