No registrations found.
ID
Source
Brief title
Health condition
prosocial behavior, oxytocin, 5-HT1a receptor, MDMA
Sponsors and support
Dept. of NP & PP, Fac of FPN, UM
P.O.Box 616
6200 MD Maastricht
tel: +31433881902
fax: +31433884560
email: k.kuypers@maastrichtuniversity.nl
Intervention
Outcome measures
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.
Background 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.
Study objective
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.
Study design
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.
Intervention
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);
4. Placebo.
K.P.C. Kuypers
Universiteit Maastricht, Fac. FPN. Dept. NP&PP, PB 616
Maastricht 6200 MD
The Netherlands
+31 (0)433881902
k.kuypers@psychology.unimaas.nl
K.P.C. Kuypers
Universiteit Maastricht, Fac. FPN. Dept. NP&PP, PB 616
Maastricht 6200 MD
The Netherlands
+31 (0)433881902
k.kuypers@psychology.unimaas.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2518 |
| NTR-old | NTR2636 |
| CCMO | NL34859.068.10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON36227 |