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.

The results of the study show no significant difference between sexes, but do show the influence of the different genotypes on the metabolism of MDMA:

“Principal findings show that subjects reached similar MDMA plasma concentrations, and experienced similar positive effects, irrespective of gender or CYP2D6 (not taking into consideration poor or ultra-rapid metabolizers) or COMT genotypes. However, HMMA plasma concentrations were linked to CYP2D6 genotype (higher with two functional alleles). Female subjects displayed more intense physiological (heart rate, and oral temperature) and negative effects (dizziness, sedation, depression, and psychotic symptoms). Genotypes of COMT val158met or 5-HTTLPR with high functionality (val/val or l/*) determined greater cardiovascular effects, and with low functionality (met/* or s/s) negative subjective effects (dizziness, anxiety, sedation). In conclusion, the contribution of MDMA pharmacokinetics following 1.4 mg/kg MDMA to the gender differences observed in drug effects appears to be negligible or even null. In contrast, 5-HTTLPR and COMT val158met genotypes play a major role.“

Two other papers cover the results.

Topic Healthy Subjects
Compound MDMA
Country Spain
Visit trial
Status Completed
Results Published
Start date 01 May 2003
End date 01 May 2011
Chance of happening 100%
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.

NCT 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
This company doesn't have a full profile yet, it is linked to a clinical trial.

Data attribution

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