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Can memantine prevent memory impairment induced by MDMA in humans.


- candidate number9166
- NTR NumberNTR2792
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-feb-2011
- Secondary IDs11-3-007  MEC Maastricht University
- Public TitleCan memantine prevent memory impairment induced by MDMA in humans.
- Scientific TitleCan memantine prevent memory impairment induced by MDMA in humans.
- ACRONYMMEM-MDMA
- hypothesisIt is predicted that pretreatment with memantine can prevent the memory impairment that is usualy caused by MDMA.
- Healt Condition(s) or Problem(s) studiedMemory impairment, MDMA
- Inclusion criteria1. Recreational MDMA users;
2. Age between 18 and 40 years;
3. Free from psychotropic medication;
4. Good physical health;
5. Absence of any major medical, endocrine and neurological condition;
6. Normal weight;
7. Written Informed Consent.
- Exclusion criteria1. History of drug abuse (other than the use of MDMA) or addiction;
2. Pregnancy or lactation;
3. Excessive drinking;
4. Hypertension;
5. Current or history of psychiatric disorder.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-apr-2011
- planned closingdate1-apr-2012
- Target number of participants16
- Interventions1. Placebo - Placebo;
2. Memantine 20 mg - Placebo;
3. Placebo - MDMA 75 mg;
4. Memantine 20 mg - MDMA 75 mg.
- Primary outcomeMemory performance is the primary outcome and is measured immediately after each cannabis/placebo treatment. Memory is measured with a verbal memory test and a prospecitve memory test.
- Secondary outcomeEvent related potentials are measured while performing the verbal memory tast. P300 will be the outcome measure of the Event related potentials. Measurable and perceptual differences in speech will be studied between MDMA-influenced and non-intoxicated speech.
- TimepointsSubjects will be pretreated with placebo or memantine. Two hours later they will be treated with placebo or MDMA.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES E.L. Theunissen
- CONTACT for SCIENTIFIC QUERIES E.L. Theunissen
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
NWO
- PublicationsN/A
- Brief summaryPrevious studies showed that ecstacy (MDMA) affects cognitive performance, such as memory. Animal studies have shown that memantine, a drug used in the treatment of alzheimer patients, can prevent the memory problems caused by ecstacy.
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 a week will be respected.
- Main changes (audit trail)
- RECORD24-feb-2011 - 13-mrt-2011


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