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Role of Serotonin in Acute and Subacute MDMA Effects

C

California Pacific Medical Center Research Institute

Status

Completed

Conditions

MDMA Mechanism of Action

Treatments

Drug: MDMA and citalopram
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00838305
28.065-1

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

13 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
drug: placebo subjects also get citalopram and placebo in a 2x2 crossover design
Treatment:
Drug: Placebo
mdma
Experimental group
Description:
drug: mdma subjects also get citalopram and placebo in a 2x2 crossover design
Treatment:
Drug: MDMA and citalopram

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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