The aim of this study is therefore to investigate the role of the 5-HT2a receptor in the MDMA-induced effects on social behaviour.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Sociaal gedrag en cognitief functioneren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Dependent variables of cognitive and affective emapthy scales and tasks
Secondary outcome
- Dependent variables of social interaction task, attitudes task, memory
- Drug and hormone concentrations in the blood
Background summary
The neurobiological mechanism underlying prosocial behaviour is yet not known.
Fundamental knowlegde about this mechanism could lead to new input for
researchers seeking new insights into the biological mechanism of diseases in
which prosocial behaviour is lacking.
In the current study, the prosocial partydrug ecstasy (MDMA) will be used to
induce a prosocial state. We know, from previous studies that MDMA induces an
increase in emotional empathy and that this effect is not attributable to the
effects of MDMA on the 5-HT1a receptor. New evidence suggests that the 5-HT2a
receptor might play a role in this mechanism.
Study objective
The aim of this study is therefore to investigate the role of the 5-HT2a
receptor in the MDMA-induced effects on social behaviour.
Study design
Design:
The study will be conducted according to a double-blind, placebo-controlled,
crossover design with 4 treatment conditions, on 4 occasions, seperated each by
a minimum of 7 days washout.
Treatments:
Treatments will be: MDMA-75 mg, Ketanserin-40 mg, MDMA-75 mg + Ketanserin-40
mg, placebo. Both MDMA and ketanserin will be administered orally as a capsule.
Both treatments will have matching placebos (= that will be identical in smell,
color and form and will be indistinguishable from the active treatments).
The dosage of MDMA (75 mg) and that of ketanserin (40 mg) are based on
previous acute studies. Concentraties in the blood will reach peak plasma
concentrations at 90 minutes after intake of MDMA and between 1/2-2h after
intake of ketanserin.
Intervention
Administration of treatments (see study design) abd collection of a blood
sample each testday to determine durg and hormone concentrations in the blood
Study burden and risks
The risks are confined to possible side effects of the treatments: MDMA and
ketanseri. Subjects are ecstasy/MDMA users and are therefore familiar with
possible side effects of MDMA.
Study burden in total: 18 hours, spread over minimally 5 weeks.
Universiteitssingel 40
Maastricht 6229 ER
NL
Universiteitssingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
Healthy volunteers, aged between 18-35 years, who have used MDMA/Ecstasy with a minimum of 3 times ever and a maximum of 200 times, and at least one during the past year.;(Also see page 14 of the research protocol)
Exclusion criteria
Never used ecstasy/MDMA.;(Also see page 14-15 of the research protocol)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-005168-82-NL |
| CCMO | NL42465.068.12 |
| Other | NTR TC 3691 |
| OMON | NL-OMON29427 |