Skip to main content
OpenTrials
Completed

NCT Number: NCT01447472

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metabolism Behavior Coitus Interaction Sexual Behavior

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Barcelona, 08003, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MDMA

Drug

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

Other names: Ecstasy

Primary outcomes

  1. Concentrations of dextromethorphan in plasma and urine.

    Time frame: 240 hours after MDMA dosing.

    Blood samples and urine to determine dextromethorphan and dextrorphan concentrations until 240h.

  2. Concentrations of caffeine in plasma and urine.

    Time frame: 24 hours after MDMA dosing.

    Blood samples and urine to determine caffeine and theobromine concentrations until 240h.

  3. Concentrations of MDMA and metabolites (influence of gender)

    Time frame: 48h after MDMA administration.

    Determination of MDMA and metabolites concentrations in plasma and urine during 48h. Influence of gender male/female.

  4. Concentrations of MDMA and metabolites (influence of genetics)

    Time frame: 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 outcomes

  1. Effects of MDMA on physiological response.

    Time frame: 24h

    Effects of MDMA on blood preassure, heart rate, temperature, pupil diameter, esophoria. Influence of gender and genetic polymorphisms.

  2. Effects of MDMA on physiological response.

    Time frame: 24h

    Effects of MDMA on subjective effects (feelings of intoxication, euphoria, bad effects etc) and psychological tests (VESSPA, ARCI). Influence of gender and genetic polymorphisms.

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2009
Study completion
2011
First posted
Oct 6, 2011
Registry last updated
Oct 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.