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CompletedPhase 1

-Methylenedioxymethamphetamine (MDMA, Ecstasy) Induced Changes in Drug Metabolism: Gender and Genetic Polymorphisms

NCT01447472 · Parc de Salut Mar

Closed to entry
Status
Not accepting participants
Phase 1
Phase
27
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

The purpose of this study are: 1. to evaluate the involvement of CYP2D6, CYP3A4 and CYP1A2 (through dextromethorphan and caffeine challenges), and catechol-O-methyltransferase (COMT)in MDMA metabolism 2. to evaluate gender differences in the human pharmacology of MDMA 3. to study the influence of some genetic polymorphisms (CYP2D6, COMT, SERT) in the effects and pharmacokinetics of MDMA.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Concentrations of dextromethorphan in plasma and urine.

    Measured over 240 hours after MDMA dosing.

  • Concentrations of caffeine in plasma and urine.

    Measured over 24 hours after MDMA dosing.

  • Concentrations of MDMA and metabolites (influence of gender)

    Measured over 48h after MDMA administration.

  • Concentrations of MDMA and metabolites (influence of genetics)

    Measured over 48h after MDMA administration.

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 45 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * Healthy male and female adults, the recreational use of MDMA on at least ten occasions (two in the previous year), and the EM phenotype for CYP2D6 activity determined using dextromethorphan as a selective probe drug. * Women had to present a regular menstrual cycle and not take oral contraceptives. Exclusion Criteria: * Daily consumption \>20 cigarettes and \>4 standard units of ethanol in men (\>2 in women) * Regular ingestion of medication in the month preceding the study * Presence of major psychiatric disorders * History of abuse or drug dependence (except for nicotine dependence) * Psychiatric adverse reactions after MDMA consumption.

Where

1 study site

FacilityCityRegionCountry
IMIM-Hospital del Mar (Institut de Recerca Hospital del Mar)BarcelonaBarcelonaSpain

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT01447472 on ClinicalTrials.gov →

Last updated in the registry 2011-10-06. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

All 2 trials from Parc de Salut Mar →