Role of Serotonin in Acute and Subacute MDMA Effects

NCT00838305 | Completed

• 1 other identifier: 28.065-1
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

MDMA Mechanism of Action

Keywords

MDMA; citalopram; serotonin; psychedelic

Outcome Measures

Primary Outcomes (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

  24 hours

Secondary Outcomes (1)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

drug: placebo subjects also get citalopram and placebo in a 2x2 crossover design

Drug: Placebo

mdma

EXPERIMENTAL

drug: mdma subjects also get citalopram and placebo in a 2x2 crossover design

Drug: MDMA and citalopram

Interventions

MDMA and citalopram DRUG

MDMA 1.5 mg/kg and citalopram 20 mg

mdma

Placebo DRUG

drug: placebo subjects also get citalopram and placebo in a 2x2 crossover design

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• California Pacific Medical Center Research Institute: lead

Study Sites (1)

CPMC Research Institute, St.Luke's Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Interventions

N-Methyl-3,4-methylenedioxyamphetamine; Citalopram

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Propylamines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: January 23, 2009
• First Posted: February 6, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: August 1, 2011
• Last Updated: May 31, 2013

Record last verified: 2013-05

Locations

US (1)