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Role of Serotonin in Acute and Subacute MDMA Effects

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00838305
Enrollment
13
Registered
2009-02-06
Start date
2009-02-28
Completion date
2011-08-31
Last updated
2013-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MDMA Mechanism of Action

Keywords

MDMA, citalopram, serotonin, psychedelic

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.

Interventions

DRUGMDMA and citalopram

MDMA 1.5 mg/kg and citalopram 20 mg

DRUGPlacebo

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

Sponsors

California Pacific Medical Center Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime 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 MDMA24 hours

Secondary

MeasureTime frame
To determine if administration of the SSRI citalopram decreases the acute (post 1 to 4hr) social and emotional and cognitive effects of MDMApost 1-4 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026