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.

Conducted by Parc de Salut Mar in collaboration with the National Institute on Drug Abuse (NIDA), the study assessed the role of CYP2D6, CYP3A4, CYP1A2, and catechol-O-methyltransferase (COMT) in MDMA metabolism, along with gender differences and the influence of genetic polymorphisms (CYP2D6, COMT, SERT) on MDMA’s pharmacokinetics and effects. Healthy male and female adults with prior MDMA use received a single MDMA dose (1.5 mg/kg; range 75-100 mg). The study measured MDMA and metabolite concentrations in plasma and urine, as well as physiological and subjective effects, to better understand individual variations in MDMA metabolism.

Topic Healthy Subjects
Compound MDMA
Country Spain
Visit trial
Status Completed
Results Published No
Start date 01 May 2003
End date 01 May 2011
Phase Phase I
Design Open
Type Interventional
Generation First
Participants 27
Sex All
Age 18- 45
Therapy No

Trial Details

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.

Trial Number NCT01447472

Sponsors & Collaborators

Parc de Salut Mar
This company doesn't have a full profile yet, it is linked to a clinical trial.

National Institute on Drug Abuse
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Data attribution

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