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

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ClinicalTrials.gov Identifier: NCT01447472
Recruitment Status : Completed
First Posted : October 6, 2011
Last Update Posted : October 6, 2011
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Parc de Salut Mar

Tracking Information
First Submitted Date  ICMJE September 27, 2011
First Posted Date  ICMJE October 6, 2011
Last Update Posted Date October 6, 2011
Study Start Date  ICMJE May 2003
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2011)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2011)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE -Methylenedioxymethamphetamine (MDMA, Ecstasy) Induced Changes in Drug Metabolism: Gender and Genetic Polymorphisms
Official Title  ICMJE Human Study of the Metabolic Changes Induced by 3,4-methylenedioxymethamphetamine (MDMA, Ecstasy) in the Metabolism of Dextromethorphan and Caffeine
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Metabolism
  • Interaction
Intervention  ICMJE Drug: MDMA
One single dose of MDMA ( 1.5 mg/kg; range: 75-100 mg)
Other Name: Ecstasy
Study Arms  ICMJE Experimental: MDMA
One single dose of MDMA (1.5 mg/kg; range 75-100 mg)
Intervention: Drug: MDMA
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 5, 2011)
27
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01447472
Other Study ID Numbers  ICMJE IMIMFTCL/MDMA/6
AEMPS no.04-0013 ( Other Identifier: Spanish Medicines Agency (identification number) )
5R01DA017987 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Parc de Salut Mar
Study Sponsor  ICMJE Parc de Salut Mar
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Magí Farre, PhD IMIM-Hospital del Mar (Institut de Recerca Hospital del Mar)
PRS Account Parc de Salut Mar
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP