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

Parc de Salut Mar

Status and phase: Completed; Phase 1

Conditions: Metabolism; Interaction

Treatments: Drug: MDMA

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01447472

IMIMFTCL/MDMA/6

5R01DA017987 (U.S. NIH Grant/Contract)

AEMPS no.04-0013 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts 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.

Trial design

27 participants in 1 patient group

MDMA

Experimental group

Description:

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

Treatment:

Drug: MDMA