MedTrace Logo

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

NCT01447472 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2011-10-06

No results posted yet for this study

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.

Conditions

  • Metabolism
  • Interaction

Interventions

DRUG

MDMA

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

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Parc de Salut Mar

    lead OTHER

Principal Investigators

  • Magí Farre, PhD · IMIM-Hospital del Mar (Institut de Recerca Hospital del Mar)

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-05-31
Primary Completion
2009-05-31
Completion
2011-05-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01447472 on ClinicalTrials.gov