Role of Serotonin in Acute and Subacute MDMA Effects

Not Applicable

Completed

• Conditions: MDMA Mechanism of Action
• Interventions: Drug: Placebo; Drug: MDMA and citalopram

• Registration Number: NCT00838305
• Lead Sponsor: California Pacific Medical Center Research Institute

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 available

Study Timeline

• Study First Submitted: 2009-01-23
• Study Start: 2009-02
• Study First Submitted QC: 2009-02-05
• Study First Posted: 2009-02-06
• Primary Completion: 2009-12
• Study Completion: 2011-08
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-29
• Last Update Posted: 2013-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	drug: placebo subjects also get citalopram and placebo in a 2x2 crossover design
mdma	MDMA and citalopram	drug: mdma subjects also get citalopram and placebo in a 2x2 crossover design

Primary Outcome Measures

Name	Time	Method
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	24 hours

Secondary Outcome Measures

Name	Time	Method
To determine if administration of the SSRI citalopram decreases the acute (post 1 to 4hr) social and emotional and cognitive effects of MDMA	post 1-4 hours

Trial Locations

Locations (1)

CPMC Research Institute, St.Luke's Hospital; 🇺🇸 San Francisco, California, United States