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Role of Serotonin in Acute and Subacute MDMA Effects

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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
MDMA Mechanism of Action Drug: MDMA and citalopram Drug: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Study Start Date : February 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : August 2011

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
drug: placebo subjects also get citalopram and placebo in a 2x2 crossover design
 Drug: Placebo
drug: placebo subjects also get citalopram and placebo in a 2x2 crossover design
Experimental: mdma
drug: mdma subjects also get citalopram and placebo in a 2x2 crossover design
 Drug: MDMA and citalopram
MDMA 1.5 mg/kg and citalopram 20 mg


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838305


Locations
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United States, California
CPMC Research Institute, St.Luke's Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
California Pacific Medical Center Research Institute
More Information
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Responsible Party: John Mendelson, MD, Senior Scientist, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00838305    
Other Study ID Numbers: 28.065-1
First Posted: February 6, 2009    Key Record Dates
Last Update Posted: May 31, 2013
Last Verified: May 2013
Keywords provided by John Mendelson, MD, California Pacific Medical Center Research Institute:
MDMA
citalopram
serotonin
psychedelic
Additional relevant MeSH terms:
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Citalopram
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
 Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs