Oxytocin and the Processing of Social Stress-Associated Chemosignals

NCT ID: NCT03265899

Last Updated: 2017-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-01
• Study Completion Date: 2016-11-30

Brief Summary

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

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Oxytocin

40 IU Oxytocin, intranasal application 30 min prior to the experiment

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

40 IU; 5 puffs balanced across nostrils, at an inter-puff interval of 30 seconds

Placebo

sodium chloride solution, intranasal application 30 min prior to the experiment

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo nasal spray, 5 puffs balanced across nostrils, at an inter-puff interval of 30 seconds

Interventions

Oxytocin

40 IU; 5 puffs balanced across nostrils, at an inter-puff interval of 30 seconds

Intervention Type: DRUG

Placebo

Placebo nasal spray, 5 puffs balanced across nostrils, at an inter-puff interval of 30 seconds

Intervention Type: DRUG

Other Intervention Names

Syntocinon-Spray, Novartis; Placebo-Spray, Novartis

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Bonn

OTHER

Sponsor Role: lead

Responsible Party

Rene Hurlemann

Prof. Dr. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rene Hurlemann, MSc MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, University of Bonn, Germany

Other Identifiers

OXT_OLF_2017

Identifier Type: -

Identifier Source: org_study_id