The primary objective is to investigate the effect of conditioning with oxytocin on endogenous oxytocin release. Secondary, we will investigate the effect of oxytocin conditioning on cortisol and on brain activity, both in resting state and in…
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Brief title
Condition
- Other condition
Synonym
Health condition
Het onderzoek wordt bij gezonde personen uitgevoerd. Uitkomsten uit deze lijn van onderzoek bieden nieuwe handvaten voor verklaringsmodellen en therapeutische interventies voor aandoeningen waarbij een verandering in de functie van het endocriene systeem optreedt.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is salivary oxytocin level during evocation in the
experimental group compared to the placebo group. Oxytocin will be measured
four times during the first two evocation sessions (once before and in 5, 20
and 30 after the drug or placebo administration) and twice during the third
evocation day.
Secondary outcome
Additional study parameters assessed at baseline and at the evocation phase
are: salivary cortisol, pain sensitivity and during the third evocation day
only, resting state and task-related (emotional faces, infant crying, and pain
stimulation) brain activity, pain sensitivity levels and physiological data
using the nociceptive level index during thermal pain stimulation.
Additionally, to explore the possible influence of genotype on the effects of
conditioning, the 5-HTTLPR genotype and other candidate genotypes will be
assessed in saliva.
Background summary
Preliminary evidence suggests that endogenous hormone secretion, such as
cortisol or insulin, might be behaviourally conditionable in humans. Whether
other neuroendocrine hormones such as oxytocin can be conditioned as well is
currently unclear and no studies focused yet on possible neural mechanisms of
conditioning.
Study objective
The primary objective is to investigate the effect of conditioning with
oxytocin on endogenous oxytocin release. Secondary, we will investigate the
effect of oxytocin conditioning on cortisol and on brain activity, both in
resting state and in response to tasks relevant to oxytocin release.
Study design
A previously validated two-phase randomized placebo-controlled conditioning
paradigm will be applied. After a screening session, participants will be
randomly allocated to one of three groups: 1) an experimental group, 2) a
placebo group, or 3) a drug-control group. In the first phase, the acquisition
phase, a distinctive odor (conditioned stimulus, CS) will be associated with
the administration of either exogenous oxytocin (unconditioned stimulus, US;
experimental and drug-control groups) or placebo (placebo group) on three
consecutive days. The second phase, the evocation phase, will start 4 days
after the last acquisition day. Participants in the experimental and placebo
groups will be given a placebo in combination with the CS during three
consecutive days, whereas the drug-control group receives oxytocin without the
CS. During the last evocation day, a functional Magnetic Resonance Imaging
(fMRI) brain scan will be conducted in all groups.
Intervention
In the experimental group, participants will receive a 24 IU dose of oxytocin
via a nasal spray during the acquisition phase and an identically looking
placebo nasal spray during the evocation phase. In the placebo group,
participants will receive a placebo in both phases. In the drug-control group,
24 IU oxytocin will be administered in both phases.
Study burden and risks
Risks associated with the study procedures are minimal. Several studies have
been conducted in humans with repeated doses up to 80 IU of oxytocin without
reporting adverse side effects. There are no known risks associated with
non-invasive fMRI acquisition and participants will be screened for
claustrophobia. The standardized pain application device (Pathway, Medoc) has
built-in safeguards. Participants can stop the study at any time for any
reason. The burden of study participation is considered moderate, involving an
approximate total time investment of 6 hours and 20 minutes. Studying the
effects of oxytocin conditioning will shed more light on the mechanisms of
conditioning endocrine parameters and on various physiological and
psychological functions.
Wassenaarseweg 52
Leiden 2333 AK
NL
Wassenaarseweg 52
Leiden 2333 AK
NL
Listed location countries
Age
Inclusion criteria
healthy, female, premenopausal, 18-35 years old, right-handed, using oral contraceptives
Exclusion criteria
Somatic and/or psychiatric conditions, (intendend) pregnancy or breast-feeding, heavy use of (illegal) drugs including cannabis and habits of heavy drinking, known sensitivity or hypervigilance to one of the ingredients of the oxytocin or the odor used in this experiment.
Design
Recruitment
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 |
|---|---|
| CCMO | NL52683.058.15 |
| OMON | NL-OMON20692 |