Purpose of the study is to find out if memantine in humans also has benificial effects on memory when given in combination with ecstacy. Therefore, ecstacy will be given in combination with memantine. A secondary goal is to find out the effects of…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
cognitief functioneren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Performance on memory tasks
Secondary outcome
Event related potentials and speech recordings
Background summary
Previous studies showed that ecstacy (MDMA) affects cognitive performance, such
as memory. Many studies showed that ecstacy impairs the proces of learning new
information. It is however, not known by which mechanism ecstacy causes this
memoryproblem. Animal studies have shown that memantine, a drug used in the
treatment of alzheimer patients, can prevent the memory problems caused by
ecstacy.
Study objective
Purpose of the study is to find out if memantine in humans also has benificial
effects on memory when given in combination with ecstacy. Therefore, ecstacy
will be given in combination with memantine. A secondary goal is to find out
the effects of ecstacy on speech. Therefore speech will be recorded.
Study design
This will be a double blind, placebo controlled, 4-way cross over design.
Subjects will be pretreated with placebo or memantine. Two hours later they
will be treated with placebo or MDMA. In between test days, a wash-out period
of at least 2 weeks will be respected.
Intervention
Placebo + Placebo, Placebo + MDMA, Memantine + Placebo, Memantine + MDMA.
Conditions will be randomised over the 4 test days.
Study burden and risks
Total amount of invested time for each subjects is about 27 hours. A medical
screening will take place, including an electrocardiogram (ECG), urine and
blood (8ml) analyses. Each test day will last about 6 hours. Subject have to
make sure to get a good nights rest before each test day (app. 6 hours). Also
they are not allowed to use cafeine or alcohol 24 hours prior to each testday.
From a week before the medical screening until the end of the last test day,
they can not use any drugs.
Postbus 616
6200 MD Maastricht
NL
Postbus 616
6200 MD Maastricht
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-024543-33-NL |
| CCMO | NL35155.068.11 |
| Other | NTR nog geen nummer toegekend |