none
Conditions
Interventions
Trade Name: Ebixa
Product Name: Memantine
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: MDMA
Product Code: MD
Sponsors
Maastricht University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Recreational MDMA users (used at least 3 times of which at least once during the previous year, and maximally 200 times) Age between 18 and 40 years Free from psychotropic medication Good physical health as determined by medical examination and laboratory analysis Absence of any major medical, endocrine and neurological condition Normal weight, body mass index (weight/height2) between 18.5 and 28 kg/m2 Written Informed Consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: History of drug abuse (other than the use of MDMA) or addiction Pregnancy or lactation Excessive drinking (> 20 alcoholic consumptions a week) Hypertension (diastolic> 90; systolic> 140) Current or history of psychiatric disorder Liver dysfunctioning (Serious) side effects to previous MDMA use History of cardiac dysfunctions (arrhythmia, ischemic heart disease,…) For women: no use of a reliable contraceptive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the present study is to find out whether MDMA-induced acute memory impairment can be prevented by memantine treatment. It is predicted that the NMDA receptor antagonist memantine will prevent memory impairments induced by MDMA Main study parameter: The mean immediate recall score of the Visual Verbal Learning task. This variable was previously shown to be sensitive for the memory impairing effect of MDMA (Kuypers & Ramaekers, 2005).;Secondary Objective: A second aim of the study is to investigate the influence of MDMA on speech. It is expected that measurable and perceptual differences in speech can be found between MDMA-influenced and non-intoxicated speech. ;Primary end point(s): The mean immediate recall score of the Visual Verbal Learning task after pretreatment with PR1 and treatment with PR2. | — |
Countries
Netherlands
Outcome results
None listed