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Role of Serotonin in Acute and Subacute MDMA Effects

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: NCT00838305
Recruitment Status : Completed
First Posted : February 6, 2009
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 23, 2009
First Posted Date  ICMJE February 6, 2009
Last Update Posted Date May 31, 2013
Study Start Date  ICMJE February 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2009)
To determine if administration of the selective serotonin reuptake inhibitor (SSRI) citalopram decreases the subacute (post 24hr) discontinuation effects of MDMA in experienced MDMA users given a modest dose of MDMA [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2009)
To determine if administration of the SSRI citalopram decreases the acute (post 1 to 4hr) social and emotional and cognitive effects of MDMA [ Time Frame: post 1-4 hours ]
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 Role of Serotonin in Acute and Subacute MDMA Effects
Official Title  ICMJE Not Provided
Brief Summary

The purpose of this study is to measure the effects of MDMA (particularly its emotional effects) and to determine the role of serotonin in these effects. Serotonin is a neurotransmitter, which is a chemical that is released by some brain cells to communicate with other brain cells. Many of the effects of MDMA are thought to be the result of increased serotonin release.

In order to understand the effects of MDMA and role of serotonin in these effects, we will administer MDMA alone and in combination with the antidepressant citalopram (one trade name for this is Celexa). Citalopram decreases the ability of MDMA to release serotonin. Citalopram will therefore decrease any of MDMA's effects that are the result of serotonin release; we want to measure this.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE MDMA Mechanism of Action
Intervention  ICMJE
  • Drug: MDMA and citalopram
    MDMA 1.5 mg/kg and citalopram 20 mg
  • Drug: Placebo
    drug: placebo subjects also get citalopram and placebo in a 2x2 crossover design
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    drug: placebo subjects also get citalopram and placebo in a 2x2 crossover design
    Intervention: Drug: Placebo
  • Experimental: mdma
    drug: mdma subjects also get citalopram and placebo in a 2x2 crossover design
    Intervention: Drug: MDMA and citalopram
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: May 29, 2013)
13
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2009)
20
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy men or women aged 18 to 50 years
  • Experienced with MDMA

Exclusion Criteria:

  • Significant physical or psychiatric illness which might impair the ability to safely complete the study or that might be complicated by the study drugs, including prior seizures (after age 8), history of major depression, or other active neurological disease or clinically significant abnormalities on physical examination or screening laboratory values
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 NCT00838305
Other Study ID Numbers  ICMJE 28.065-1
Has Data Monitoring Committee Not Provided
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 Not Provided
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