Oxytocin and the Processing of Social Stress-Associated Chemosignals

Healthy Volunteers Clinical Trial

Official title:

Double-blind, Placebo-controlled, Randomized Study: Oxytocin Modulation of Stress-Associated Chemosignals Processing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265899
• Other study ID #: OXT_OLF_2017
• Status: Completed
• Phase: Phase 1
• First received: August 18, 2017
• Last updated: August 25, 2017
• Start date: July 1, 2015
• Est. completion date: November 30, 2016

Study information

• Verified date: August 2017
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether oxytocin modulates the processing of stress-associated chemosignals and which substrates are involved.

Description:

Social transmission of stress and fear is not restricted to visual or auditory cues, but extends to the olfactory domain, a phylogenetically more ancient sense. Exposure to axillary sweat from healthy volunteers undergoing an emotional stressor task evokes a strong vicarious stress response on the behavioral and neural level.Particularly, anxious individuals have been shown to exhibit a heightened sensitivity to social chemosensory stress cues (axillary sweat). The neuropeptide oxytocin (OXT) exerts anxiolytic and anti-stress effects in visual and auditory modalities, however, it still elusive whether OXT also modulates the processing of stress-associated chemosignals. Axillary sweat were obtained from an unrelated sample of 30 healthy men undergoing the Trier Social Stress Test and ergometer training as control.Subsequently, subjects completed a forced-choice emotional face recognition task composed of stimuli with varying intensities (neutral to fearful), while they were exposed to both sweat stimuli and a non-social control odor (raspberry) after OXT or placebo administration, respectively. The investigators expect that OXT selectively diminishes chemosensory-induced behavioral biases and neural responses to stress-related odors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 30, 2016
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers

• Right-handed

Exclusion Criteria:

• Current or past psychiatric disease

• Current or past physical illness

• Psychoactive medication

• Tobacco smokers

• MRI contraindications (e.g. metal in body, claustrophobia)

• Anosmia

• Medication known to interfere with olfactory processing

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Oxytocin
40 IU; 5 puffs balanced across nostrils, at an inter-puff interval of 30 seconds
• Placebo
Placebo nasal spray, 5 puffs balanced across nostrils, at an inter-puff interval of 30 seconds

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced-choice ratings of morphed emotional faces with varying intensities (neutral to fearful).	After each trial, subjects were asked to use a button response grip to indicate whether they perceived the depicted face as neutral or fearful.	30 min after nasal spray administration
Primary	Response time for facial stimuli ratings.		30 min after nasal spray administration
Primary	Blood-oxygen-level dependent signal in response to chemosensory cues.	The modulatory effect of oxytocin on neural correlates Using functional magnetic resonance imaging, signal changes in the amygdala, hippocampus and the anterior cingulate cortex in response to olfactory cues of stress and sport (axillary sweat obtained from an unrelated sample of 30 healthy men undergoing the Trier Social Stress Test and ergometer training as control).	30 minutes after nasal spray administration
Secondary	Questionnaire measurement of mood (PANAS).		15 minutes before the nasal spray administration and (on average) 10 minutes after the fMRI experiment
Secondary	Saliva oxytocin concentrations		immediately before the nasal spray administration and (on average) 10 minutes after the fMRI experiment
Secondary	Questionnaire measurement of anxiety (STAI).		15 minutes after nasal spray administration and (on average) 10 minutes after the fMRI experiment