Status:
COMPLETED
-Methylenedioxymethamphetamine (MDMA, Ecstasy) Induced Changes in Drug Metabolism: Gender and Genetic Polymorphisms
Lead Sponsor:
Parc de Salut Mar
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Metabolism
Interaction
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 metabolis...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01447472
Start Date
May 1 2003
End Date
May 1 2011
Last Update
October 6 2011
Active Locations (1)
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1
IMIM-Hospital del Mar (Institut de Recerca Hospital del Mar)
Barcelona, Barcelona, Spain, 08003