Role of Serotonin in Acute and Subacute MDMA Effects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Mendelson, MD, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00838305
First received: January 23, 2009
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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 Intervention
MDMA Mechanism of Action
Drug: MDMA and citalopram
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by California Pacific Medical Center Research Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: February 2009
Study Completion Date: August 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838305

Locations
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

No publications provided

Responsible Party: John Mendelson, MD, Senior Scientist, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00838305     History of Changes
Other Study ID Numbers: 28.065-1
Study First Received: January 23, 2009
Last Updated: May 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by California Pacific Medical Center Research Institute:
MDMA
citalopram
serotonin
psychedelic

Additional relevant MeSH terms:
Citalopram
Dexetimide
N-Methyl-3,4-methylenedioxyamphetamine
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Hallucinogens
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on July 22, 2014