Methylenedioxymethamphetamine (MDMA, Ecstasy) Induced Changes in Drug Metabolism: Gender and Genetic Polymorphisms
This open-label trial (n=27) investigates how MDMA (105mg/70kg) is metabolised by the body and how differences in genes and sex (male/female) influence this.
Detailed Description
A Phase I, non-randomised, single-group study in healthy volunteers to evaluate the roles of CYP2D6, CYP3A4 and CYP1A2 (using dextromethorphan and caffeine probes) and COMT in MDMA metabolism, and to assess gender differences and selected genetic polymorphisms (CYP2D6, COMT, SERT) on MDMA pharmacokinetics and effects.
Participants received a single oral dose of MDMA (1.5 mg/kg reported; registry notes range 75–100 mg). Outcomes include pharmacokinetic measures, metabolic probe responses, and genotype–phenotype associations.
Study Protocol
Preparation
Dosing
Integration
Study Arms & Interventions
MDMA
experimentalSingle-group single-dose MDMA (1.5 mg/kg; reported range 75–100 mg).
Interventions
- MDMA1.5 mg/kgvia Oral• single dose• 1 doses total
Reported range 75–100 mg; also described as ~105 mg for 70 kg; other name: Ecstasy.
Participants
Inclusion Criteria
- Healthy male and female adults; recreational use of MDMA on at least ten occasions (at least two in the previous year); EM phenotype for CYP2D6 activity determined using dextromethorphan; women with regular menstrual cycle and not taking oral contraceptives.
Exclusion Criteria
- Daily consumption >20 cigarettes and >4 standard units alcohol in men (>2 in women); regular medication in the month preceding the study; presence of major psychiatric disorders; history of abuse or drug dependence (except nicotine dependence); psychiatric adverse reactions after MDMA consumption.
Study Details
- StatusCompleted
- PhasePhase I
- Typeinterventional
- DesignNon-randomized
- Target Enrollment27 participants
- TimelineStart: 2003-05-01End: 2011-05-01
- Compound
- Topic