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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
27
One single dose of MDMA ( 1.5 mg/kg; range: 75-100 mg)
IMIM-Hospital del Mar (Institut de Recerca Hospital del Mar)
Barcelona, Barcelona, Spain
Concentrations of dextromethorphan in plasma and urine.
Blood samples and urine to determine dextromethorphan and dextrorphan concentrations until 240h.
Time frame: 240 hours after MDMA dosing.
Concentrations of caffeine in plasma and urine.
Blood samples and urine to determine caffeine and theobromine concentrations until 240h.
Time frame: 24 hours after MDMA dosing.
Concentrations of MDMA and metabolites (influence of gender)
Determination of MDMA and metabolites concentrations in plasma and urine during 48h. Influence of gender male/female.
Time frame: 48h after MDMA administration.
Concentrations of MDMA and metabolites (influence of genetics)
Determination of MDMA and metabolites concentrations in plasma and urine during 48h. Influence of gene polymorphisms of CYP2D6, CYP3A4, COMT, SERT.
Time frame: 48h after MDMA administration.
Effects of MDMA on physiological response.
Effects of MDMA on blood preassure, heart rate, temperature, pupil diameter, esophoria. Influence of gender and genetic polymorphisms.
Time frame: 24h
Effects of MDMA on physiological response.
Effects of MDMA on subjective effects (feelings of intoxication, euphoria, bad effects etc) and psychological tests (VESSPA, ARCI). Influence of gender and genetic polymorphisms.
Time frame: 24h
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