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The role of 5-HT2 and 5-HT1A receptors in 3,4-methylenedioxymethamphetamine (MDMA) induced memory impairment and impulsivity.


- candidate number8113
- NTR NumberNTR2352
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-jun-2010
- Secondary IDsP34 EPU 
- Public TitleThe role of 5-HT2 and 5-HT1A receptors in 3,4-methylenedioxymethamphetamine (MDMA) induced memory impairment and impulsivity.
- Scientific TitleThe role of 5-HT2 and 5-HT1A receptors in 3,4-methylenedioxymethamphetamine (MDMA) induced memory impairment and impulsivity.
- ACRONYM
- hypothesisTo determine the role of 5-HT2 and 5-HT1A receptors in learning and memory. It is expected that:
1. An acute dose of MDMA will produce impairments on laboratory measures of learning and memory;
2. MDMA-induced memory impairment will be reversed by coadministration of ketanserin if impairment is related to direct or indirect stimulation of 5-HT2 receptors;
3. MDMA-induced memory impairment will be reversed by coadministration of pindolol if impairment is related to direct or indirect stimulation of 5-HT1A receptors.
- Healt Condition(s) or Problem(s) studiedCognition, MDMA, 5HT
- Inclusion criteria1. Between 18 and 40 years of age;
2. Experience with the use of MDMA (at least 5 times, of which no less than one in the past 12 months);
3. Free from psychotropic medication;
4. Good physical health as determined by examination and laboratory analysis;
5. Absence of any major medical, endocrine and neurological condition;
6. Normal weight, body mass index (weight/length2) between 18 and 28 kg/m2;
7. Health insurance;
8. 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 standard alcoholic consumptions a week);
5. Smoking (>10 sigarettes a day);
6. Hypertension (diastolic> 100; systolic> 170);
7. Use of psychotropic medication;
8. History of psychiatric or neurological disorder.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2010
- planned closingdate31-dec-2011
- Target number of participants18
- InterventionsSubjects will be treated with combinations of:
1. Ketanserin 50mg / MDMA 75mg (treatment 1);
2. Pindolol 20mg / MDMA 75mg (treatment 2);
3. Placebo / MDMA 75mg (treatment 3);
4. Pindolol 20 mg / placebo (treatment 4);
5. Ketaserin 50mg / placebo (treatment 5);
6. Placebo / placebo (treatment 6).
Drugs and placebo will be administered orally in identically appearing formulations. MDMA is administered as a 25 ml solution in bitter orange peel syrup, which is ingested at once. Ketanserin and pindolol will appear in capsule form. Drugs and placebo will be administered using a double dummy technique to synchronize Tmax for all drugs.
- Primary outcomeNeurocognitive measures of memory and impulse control.
- Secondary outcomeN/A
- TimepointsNeurocognitive measures will be taken at Tmax.
- Trial web siteN/A
- statusrecruitement status not public
- CONTACT FOR PUBLIC QUERIESDr. J.G. Ramaekers
- CONTACT for SCIENTIFIC QUERIESDr. J.G. Ramaekers
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
NWO
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD3-jun-2010 - 10-jun-2010


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