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MDMA and prosocial behavior.


- candidate number8729
- NTR NumberNTR2636
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-dec-2010
- Secondary IDsNL34859.068.10 METC
- Public TitleMDMA and prosocial behavior.
- Scientific TitleCome closer: A neurobiological analysis of the prosocial effects of MDMA.
- ACRONYMMDMA & PSB
- hypothesis1. Oxytocin will mimic MDMA-induced prosocial effects;
2. Blockade of the 5-HT1A receptor will prevent occurrence prosocial effects after MDMA intake (acute, not on subsequent occasions);
3. MDMA users carrying the fast working SERT genotype variant (LaLa) will experience more pronounced prosocial effects compared with the users carrying the slow working variant.
- Healt Condition(s) or Problem(s) studiedOxytocin, MDMA, Prosocial behaviour, 5-HT1a receptor
- Inclusion criteria1. Experience with the use of MDMA (maximally 100 times in total, minimally 2 times in total; and at least once in the past 12 months);
2. Age between 18-40 years;
3. Free from medication (except oral contraception);
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/height2) between 18 and 28 kg/m2;
7. Written Informed Consent;
8. Native Dutch speaker (as some tasks require this).
- Exclusion criteria1. History of drug abuse (other than the use of MDMA) or addiction;
2. Women: 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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2011
- planned closingdate1-sep-2011
- Target number of participants18
- InterventionsAdministration of treatments* and collection of a blood sample each test day to determine treament concentrations and oxytocin concentrations in the blood.

*There are 4 treatment conditions and these willl be:
1. A single dose of MDMA (75mg);
2. Syntocinon (32 international units);
3. MDMA (75 mg) combined with Visken (20 mg);
4. Placebo.
- Primary outcome1. Dependent variables of the empathy and social interaction tasks, measured with computertasks;
2. Treatment concentrations and oxytocin concentrations in the blood (bloodsample).
- Secondary outcomeDependent variables of the control task: Word learning task.
- Timepoints1. Medical screening;
2. Training of the computer tasks;
3. 4 testdays seperated by a minimum of 7 days washout.

Total study burden= 18,5 hours, spread over minimally 5 weeks.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES K.P.C. Kuypers
- CONTACT for SCIENTIFIC QUERIES K.P.C. Kuypers
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Organization for Scientific Research (NWO)
- PublicationsN/A
- Brief summaryThe aim of the present study is to investigate the roles of oxytocin and the 5-HT1A receptor in MDMA-induced prosocial effects. Eighteen participants will go through four treatment conditions on four occasions, separated by a minimum of 7 days washout. Social behavior and mood will be assessed in the laboratory. It is hypothesized that oxytocin will mimic MDMA-induced prosocial effects and that the 5-HT1A receptor is an important mediator of these effects.
- Main changes (audit trail)
- RECORD3-dec-2010 - 11-jan-2011


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