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MDMA and memory.


- candidate number3875
- NTR NumberNTR1416
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-aug-2008
- Secondary IDsMEC 05-090.3/pl 
- Public TitleMDMA and memory.
- Scientific TitleEFFECTS OF A SINGLE DOSE OF 3.4 METHYLENEDIOXYMETHAMPHETAMINE (MDMA) ON MEMORY PERFORMANCE: A PLACEBO CONTROLLED PHARMACO-FMRI STUDY.
- ACRONYMN/A
- hypothesisThe primary aim of the study is to qualify the neural network underlying memory impairment when performing on two memory tasks after a single dose of MDMA, compared to placebo.
- Healt Condition(s) or Problem(s) studiedMemory, Methylenedioxymethamphetamine (MDMA)
- Inclusion criteria1. Experience with the use of MDMA (at least 5 times in the past 12 months);
2. Free from psychotropic medication;
3. Good physical health as determined by examination and laboratory analysis;
4. Absence of any major medical (except OAC), endocrine and neurological condition;
5. Normal weight, body mass index (weight/length2) between 18 and 28 kg/m2;
6. Found suitable for fMRI as confirmed by the fMRI checklist;
7. Written Informed Consent.
- Exclusion criteria1. History of drug abuse (other than the use of MDMA) or addiction;
2. Pregnancy or lactation;
3. Cardiovascular abnormalities as assessed by standard 12-lead ECG;
4. Excessive drinking (> 20 alcoholic consumptions a week);
5. Hypertension (diastolic> 100; systolic> 170);
6. Current or history of psychiatric disorder;
7. Presence of metal substances/parts in the body (fMRI exclusion criterium).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2005
- planned closingdate1-aug-2007
- Target number of participants16
- InterventionsSingle doses of MDMA 75mg and placebo.
- Primary outcome1. Prospective and verbal memory;
2. Performance (behavior) and BOLD;
3. Response (during prospective memory task).
- Secondary outcomeRT and no of correct responses.
- TimepointsAssessments between 1.5 and 2.5 hrs post drug.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. J.G. Ramaekers
- CONTACT for SCIENTIFIC QUERIESDr. J.G. Ramaekers
- Sponsor/Initiator University Maastricht, Faculty of Psychology
- Funding
(Source(s) of Monetary or Material Support)
University Maastricht (UM)
- PublicationsN/A
- Brief summaryProspective memory refers to the realization of delayed intentions and is an ability that is at the heart of goal directed behavior in everyday life. A number of studies have shown that MDMA users perform worse on subjective and objective measures of prospective memory as compared to non drug using controls. Interpretation of these data however may be limited due to polydrug use, psychosocial stressors and increased psychopathology that have been reported in MDMA users. The present study was designed to directly assess the pharmacological effect of MDMA on prospective memory and brain activity in a double-blind, placebo controlled, cross-over study. Twelve recreational MDMA users received MDMA 75mg and placebo and performed an objective prospective memory task during functional imaging in a 3 Tesla MR scanner.
The present study was expected to provide:
1. direct evidence for the association between MDMA and memory impairment;
2. objective assessments of prospective memory function during MDMA intoxication;
3. neural structures critically involved in memory dysfunction during MDMA intoxication.
- Main changes (audit trail)
- RECORD25-aug-2008 - 9-dec-2009


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