Trial | NCT01447472  Report issue

Title

-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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    27
The purpose of this study are:

to evaluate the involvement of CYP2D6, CYP3A4 and CYP1A2 (through dextromethorphan and caffeine challenges), and catechol-O-methyltransferase (COMT)in MDMA metabolism
to evaluate gender differences in the human pharmacology of MDMA
to study the influence of some genetic polymorphisms (CYP2D6, COMT, SERT) in the effects and pharmacokinetics of MDMA.
Study Started
May 31
2003
Primary Completion
May 31
2009
Study Completion
May 31
2011
Last Update
Oct 06
2011
Estimate

Drug MDMA

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

  • Other names: Ecstasy

MDMA Experimental

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

Criteria 

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.
No Results Posted