At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 27 enrolled
Drug / intervention
MDMAdrug
Likely dose
MDMA 1.5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Human Study of the Metabolic Changes Induced by 3,4-methylenedioxymethamphetamine (MDMA, Ecstasy) in the Metabolism of Dextromethorphan and Caffeine
In Brief
A Phase 1 clinical trial evaluating MDMA for Metabolism and Interaction. Completed, enrolled 27 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetabolism, Interaction
CountriesSpain
CollaboratorsNational Institute on Drug Abuse (NIDA)
Timeline
Phase 1CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2003
Primary CompletionMay 2009
Study CompletionMay 2011
First PostedOct 2011
TodayJul 2026
First PostedOct 6, 2011
Enrollment StartMay 1, 2003
Primary CompletionMay 1, 2009
Study CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 14.7 years ago
Interventions
MDMAdrug
One single dose of MDMA ( 1.5 mg/kg; range: 75-100 mg)