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

Human Study of the Metabolic Changes Induced by 3,4-methylenedioxymethamphetamine (MDMA, Ecstasy) in the Metabolism of Dextromethorphan and Caffeine

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01447472

Enrollment

Registered

2011-10-06

Start date

2003-05-31

Completion date

2011-05-31

Last updated

2011-10-06

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

Conditions

Interaction, Metabolism

Keywords

MDMA,, pharmacokinetics,, pharmacodynamics,, CYP2D6, COMT,, SERT, 5-HTTLPR, gender,, dextromethorphan,, caffeine.

Brief 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.

Interventions

DRUGMDMA

One single dose of MDMA ( 1.5 mg/kg; range: 75-100 mg)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Concentrations of dextromethorphan in plasma and urine.	240 hours after MDMA dosing.	Blood samples and urine to determine dextromethorphan and dextrorphan concentrations until 240h.
Concentrations of caffeine in plasma and urine.	24 hours after MDMA dosing.	Blood samples and urine to determine caffeine and theobromine concentrations until 240h.
Concentrations of MDMA and metabolites (influence of gender)	48h after MDMA administration.	Determination of MDMA and metabolites concentrations in plasma and urine during 48h. Influence of gender male/female.
Concentrations of MDMA and metabolites (influence of genetics)	48h after MDMA administration.	Determination of MDMA and metabolites concentrations in plasma and urine during 48h. Influence of gene polymorphisms of CYP2D6, CYP3A4, COMT, SERT.

Secondary

Measure	Time frame	Description
Effects of MDMA on physiological response.	24h	Effects of MDMA on blood preassure, heart rate, temperature, pupil diameter, esophoria. Influence of gender and genetic polymorphisms.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026