-Methylenedioxymethamphetamine (MDMA, Ecstasy) Induced Changes in Drug Metabolism: Gender and Genetic Polymorphisms

Phase 1

Completed

• Conditions: Metabolism; Interaction
• Interventions: Drug: MDMA

• Registration Number: NCT01447472
• Lead Sponsor: Parc de Salut Mar

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Primary Completion: 2009-05
• Study Completion: 2011-05
• Study First Submitted: 2011-09-27
• Status Verified: 2011-10
• Study First Submitted QC: 2011-10-05
• Last Update Submitted: 2011-10-05
• Study First Posted: 2011-10-06
• Last Update Posted: 2011-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MDMA	MDMA	One single dose of MDMA (1.5 mg/kg; range 75-100 mg)

Primary Outcome Measures

Name	Time	Method
Concentrations of dextromethorphan in plasma and urine.	240 hours after MDMA dosing.	Blood samples and urine to determine dextromethorphan and dextrorphan concentrations until 240h.
Concentrations of caffeine in plasma and urine.	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)	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)	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.

Secondary Outcome Measures

Name	Time	Method
Effects of MDMA on physiological response.	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.

Trial Locations

Locations (1)

IMIM-Hospital del Mar (Institut de Recerca Hospital del Mar); 🇪🇸 Barcelona, Spain