Role of Serotonin in Acute and Subacute MDMA Effects

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 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

Primary 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
    Safety Issue?: No

Secondary 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
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: California Pacific Medical Center Research Institute Other

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00838305

Study ID Number: 28.065-1

ClinicalTrials.gov Identifier: NCT00838305

Health Authority: United States: Food and Drug Administration