Role of Serotonin in Acute and Subacute MDMA Effects

NCT ID: NCT00838305

Last Updated: 2013-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-08-31

Brief Summary

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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

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Conditions

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MDMA Mechanism of Action

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

mdma

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

Group Type EXPERIMENTAL

MDMA and citalopram

Intervention Type DRUG

MDMA 1.5 mg/kg and citalopram 20 mg

Interventions

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MDMA and citalopram

MDMA 1.5 mg/kg and citalopram 20 mg

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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California Pacific Medical Center Research Institute

OTHER

Sponsor Role lead

Responsible Party

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John Mendelson, MD

Senior Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CPMC Research Institute, St.Luke's Hospital

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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28.065-1

Identifier Type: -

Identifier Source: org_study_id

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