|- candidate number||8729|
|- NTR Number||NTR2636|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-dec-2010|
|- Secondary IDs||NL34859.068.10 METC|
|- Public Title||MDMA and prosocial behavior.|
|- Scientific Title||Come closer: A neurobiological analysis of the prosocial effects of MDMA.|
|- ACRONYM||MDMA & PSB|
|- hypothesis||1. 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) studied||Oxytocin, MDMA, Prosocial behaviour, 5-HT1a receptor|
|- Inclusion criteria||1. 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 criteria||1. 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 received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2011|
|- planned closingdate||1-sep-2011|
|- Target number of participants||18|
|- Interventions||Administration 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);
|- Primary outcome||1. Dependent variables of the empathy and social interaction tasks, measured with computertasks;|
2. Treatment concentrations and oxytocin concentrations in the blood (bloodsample).
|- Secondary outcome||Dependent variables of the control task: Word learning task.|
|- Timepoints||1. 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 site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| K.P.C. Kuypers|
|- CONTACT for SCIENTIFIC QUERIES|| K.P.C. Kuypers|
|- Sponsor/Initiator ||University Maastricht (UM)|
(Source(s) of Monetary or Material Support)
|Netherlands Organization for Scientific Research (NWO)|
|- Brief summary||The 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)|
|- RECORD||3-dec-2010 - 11-jan-2011|