Oxytocin and the Processing of Social Stress-Associated Chemosignals

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Oxytocin; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxytocin; 40 IU Oxytocin, intranasal application 30 min prior to the experiment	Drug: Oxytocin; 40 IU; 5 puffs balanced across nostrils, at an inter-puff interval of 30 seconds; Other Names: Syntocinon-Spray, Novartis
Placebo Comparator: Placebo; sodium chloride solution, intranasal application 30 min prior to the experiment	Drug: Placebo; Placebo nasal spray, 5 puffs balanced across nostrils, at an inter-puff interval of 30 seconds; Other Names: Placebo-Spray, Novartis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Response time for facial stimuli ratings.		30 min after nasal spray administration
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 Outcome Measures

Outcome Measure	Time Frame
Questionnaire measurement of mood (PANAS).	15 minutes before the nasal spray administration and (on average) 10 minutes after the fMRI experiment
Saliva oxytocin concentrations	immediately before the nasal spray administration and (on average) 10 minutes after the fMRI experiment
Questionnaire measurement of anxiety (STAI).	15 minutes after nasal spray administration and (on average) 10 minutes after the fMRI experiment

Collaborators and Investigators

• Sponsor: University Hospital, Bonn
• Investigators: Principal Investigator: Rene Hurlemann, MSc MD PhD, Department of Psychiatry, University of Bonn, Germany

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): November 30, 2016
• Study Completion (Actual): November 30, 2016

Study Registration Dates

• First Submitted: August 18, 2017
• First Submitted That Met QC Criteria: August 25, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): August 29, 2017
• Last Update Submitted That Met QC Criteria: August 25, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Oxytocics; Cathartics; Oxytocin; Lactitol
• Other Study ID Numbers: OXT_OLF_2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No