-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
The purpose of this study are:
- to evaluate the involvement of CYP2D6, CYP3A4 and CYP1A2 (through dextromethorphan and caffeine challenges), and catechol-O-methyltransferase (COMT)in MDMA metabolism
- to evaluate gender differences in the human pharmacology of MDMA
- to study the influence of some genetic polymorphisms (CYP2D6, COMT, SERT) in the effects and pharmacokinetics of MDMA.
|Condition or disease||Intervention/treatment||Phase|
|Metabolism Interaction||Drug: MDMA||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Human Study of the Metabolic Changes Induced by 3,4-methylenedioxymethamphetamine (MDMA, Ecstasy) in the Metabolism of Dextromethorphan and Caffeine|
|Study Start Date :||May 2003|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2011|
One single dose of MDMA (1.5 mg/kg; range 75-100 mg)
One single dose of MDMA ( 1.5 mg/kg; range: 75-100 mg)
Other Name: Ecstasy
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01447472
|IMIM-Hospital del Mar (Institut de Recerca Hospital del Mar)|
|Barcelona, Spain, 08003|
|Principal Investigator:||Magí Farre, PhD||IMIM-Hospital del Mar (Institut de Recerca Hospital del Mar)|