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Learned oxytocin responses


- candidate number23499
- NTR NumberNTR5596
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-dec-2015
- Secondary IDsNL52683.058.15 METC LUMC
- Public TitleLearned oxytocin responses
- Scientific TitleConditioning of the neuroendocrine system: learned oxytocin responses
- ACRONYM
- hypothesisThe aim of the study is to investigate the effect of conditioning with exogenous oxytocin on endogenous oxytocin release in healthy participants. We hypothesize that conditioning will lead to altered oxytocin levels.
- Healt Condition(s) or Problem(s) studiedConditioning, Healthy volunteers
- Inclusion criteria1. Between 18 and 35 years old;
2. Good understanding of written and spoken Dutch;
3. Taking oral contraceptives;
4. Healthy.
- Exclusion criteria1. Current psychiatric (DSM-IV) conditions;
2. All conditions that might interfere with the participant's safety and/or the study protocol: claustrophobia, metal parts in or on the body that are not removable, Raynaudís phenomenon, severe neurological or neurosurgical conditions;
3. (Intended) pregnancy or breast feeding;
4. Heavy use of (illegal) drugs including cannabis and habits of heavy drinking;
5. Known sensitivity or hypervigilance to one of the ingredients of the oxytocin or the odor used in this experiment.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2016
- planned closingdate1-jan-2018
- Target number of participants99
- InterventionsThe design used in this study is based on a widely used randomized placebo-controlled conditioning paradigm, consisting of two phases (acquisition phase & evocation phase). During the acquisition phase, an association between a conditioned stimulus (CS, a distinctive odor) and an unconditioned stimulus (US, oxytocin) is established by repeated paired administration of both stimuli. In the evocation phase, it is tested whether exposure to the conditioned stimulus alone leads to the conditioned response. Participants will be randomly assigned to three groups. 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 of oxytocin will be administered in both phases.
- Primary outcomeThe main study parameter is the difference in salivary oxytocin levels during evocation between the experimental group and the placebo group.
- Secondary outcomeSecondary study parameters assessed at baseline are: salivary cortisol and pain sensitivity levels in response to the cold pressor test. During the evocation phase (1st and 2nd evocation days), psychophysiological state and task-related assessments will be measured. During the third evocation day, resting state and task-related brain activity will be measured.
- TimepointsThe study consists of 7 sessions during the course of 3 weeks. In the first week, participants will be screened for medical and psychological conditions. In the second week, the acquisition phase - consisting of 3 sessions on 3 consecutive days - takes place and in the final week during the evocation phase - again consisting of 3 consecutive sessions - the conditioned responses will be tested.
- Trial web siten/a
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. A.W.M. Evers
- CONTACT for SCIENTIFIC QUERIESProf. Dr. A.W.M. Evers
- Sponsor/Initiator Leiden University
- Funding
(Source(s) of Monetary or Material Support)
European Research Council Consolidator Grant
- Publicationsn/a
- Brief summaryPreliminary 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 on possible neural mechanisms of conditioning yet. The primary objective of the current study is to investigate the effect of conditioning with exogenous oxytocin on endogenous oxytocin release in a two-phase (acquisition and evocation) randomized placebo-controlled conditioning paradigm. Additionally, during the evocation phase (1st and 2nd evocation days), psychophysiological state and task-related assessments will be measured. On the third evocation day, resting state and task-related brain activity will be measured.
- Main changes (audit trail)
- RECORD22-dec-2015 - 14-feb-2016


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