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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT01447472
First received: September 27, 2011
Last updated: October 5, 2011
Last verified: October 2011
  Purpose

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.

Condition Intervention Phase
Metabolism
Interaction
Drug: MDMA
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Human Study of the Metabolic Changes Induced by 3,4-methylenedioxymethamphetamine (MDMA, Ecstasy) in the Metabolism of Dextromethorphan and Caffeine

Resource links provided by NLM:


Further study details as provided by Parc de Salut Mar:

Primary Outcome Measures:
  • Concentrations of dextromethorphan in plasma and urine. [ Time Frame: 240 hours after MDMA dosing. ] [ Designated as safety issue: No ]
    Blood samples and urine to determine dextromethorphan and dextrorphan concentrations until 240h.

  • Concentrations of caffeine in plasma and urine. [ Time Frame: 24 hours after MDMA dosing. ] [ Designated as safety issue: No ]
    Blood samples and urine to determine caffeine and theobromine concentrations until 240h.

  • Concentrations of MDMA and metabolites (influence of gender) [ Time Frame: 48h after MDMA administration. ] [ Designated as safety issue: No ]
    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) [ Time Frame: 48h after MDMA administration. ] [ Designated as safety issue: No ]
    Determination of MDMA and metabolites concentrations in plasma and urine during 48h. Influence of gene polymorphisms of CYP2D6, CYP3A4, COMT, SERT.


Secondary Outcome Measures:
  • Effects of MDMA on physiological response. [ Time Frame: 24h ] [ Designated as safety issue: Yes ]
    Effects of MDMA on blood preassure, heart rate, temperature, pupil diameter, esophoria. Influence of gender and genetic polymorphisms.

  • Effects of MDMA on physiological response. [ Time Frame: 24h ] [ Designated as safety issue: No ]
    Effects of MDMA on subjective effects (feelings of intoxication, euphoria, bad effects etc) and psychological tests (VESSPA, ARCI). Influence of gender and genetic polymorphisms.


Enrollment: 27
Study Start Date: May 2003
Study Completion Date: May 2011
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MDMA
One single dose of MDMA (1.5 mg/kg; range 75-100 mg)
Drug: MDMA
One single dose of MDMA ( 1.5 mg/kg; range: 75-100 mg)
Other Name: Ecstasy

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447472

Locations
Spain
IMIM-Hospital del Mar (Institut de Recerca Hospital del Mar)
Barcelona, Spain, 08003
Sponsors and Collaborators
Parc de Salut Mar
Investigators
Principal Investigator: Magí Farre, PhD IMIM-Hospital del Mar (Institut de Recerca Hospital del Mar)
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01447472     History of Changes
Other Study ID Numbers: IMIMFTCL/MDMA/6, AEMPS no.04-0013, 5R01DA017987
Study First Received: September 27, 2011
Last Updated: October 5, 2011
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Parc de Salut Mar:
MDMA,
pharmacokinetics,
pharmacodynamics,
CYP2D6, COMT,
SERT, 5-HTTLPR, gender,
dextromethorphan,
caffeine.

Additional relevant MeSH terms:
Dextromethorphan
N-Methyl-3,4-methylenedioxyamphetamine
Antitussive Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hallucinogens
Psychotropic Drugs
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014