Role of Serotonin in Acute and Subacute MDMA Effects

May 29, 2013 updated by: John Mendelson, MD, California Pacific Medical Center Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • CPMC Research Institute, St.Luke's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
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
post 1-4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Pacific Medical Center Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

January 23, 2009

First Submitted That Met QC Criteria

February 5, 2009

First Posted (Estimate)

February 6, 2009

Study Record Updates

Last Update Posted (Estimate)

May 31, 2013

Last Update Submitted That Met QC Criteria

May 29, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28.065-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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