Influence of Oxytocin on Approach-avoidance Tendencies to Social and Non-social Stimuli

June 19, 2020 updated by: Kaat Alaerts, KU Leuven
In this study, a randomized, placebo-controlled between-subject design is adopted to investigate the effect of a single-dose of intranasally administered OT on approach-avoidance related motivational tendencies during the processing of a series of social and non-social, positively and negatively valenced stimuli. To obtain a behavioral measure of approach-avoidance tendencies, participants will be able to control the viewing time of the presented stimuli, by pressing 'up' or 'down' on a keyboard. During stimulus presentation neurophysiological recordings will be performed to obtain a neural measure of approach-avoidance motivational tendencies, based on electroencephalographic recordings (EEG: frontal alpha asymmetry). Also assessments of autonomic arousal, based on skin conductance recordings will be collected.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The neuropeptide oxytocin (OT) plays an important role in a wide-range of complex social behaviors. Recently however, the 'social' specificity of OT's action has been challenged, considering several observations of non-social effects of OT showing for example that OT reliably reduces stress also in non-social tasks.

To account for these non-social effects of OT, the General Approach-Avoidance Hypothesis of OT (GAAO) has been put forward, positing that OT primarily modulates approach/ avoidance motivational tendencies and behaviors by impacting on the mesocorticolimbic circuitry linked to reward (approach) as well as cortico-amygdala circuits linked to threat (avoidance) (Harari-Dahan and Bernstein, 2014). Since the neural substrates underlying 'social' approach and avoidance are not distinct from those underlying 'non-social' approach and avoidance, the GAAO posits that the modulatory effects of OT should not be limited to social behaviors. In this view, the GAAO puts forward that OT may indeed enhance the attentional salience of many social cues, but not because they are social per se; but because many social stimuli are emotionally-evocative and personally-relevant.

In this study, a randomized, placebo-controlled between-subject design is adopted to investigate the effect of a single-dose of intranasally administered OT on approach-avoidance related motivational tendencies during the processing of a series of social and non-social, positively and negatively valenced stimuli. To obtain a behavioral measure of approach-avoidance tendencies, participants will be able to control the viewing time of the presented stimuli, by pressing 'up' or 'down' on a keyboard. During stimulus presentation neurophysiological recordings will be performed to obtain a neural measure of approach-avoidance motivational tendencies, based on electroencephalographic recordings (EEG: frontal alpha asymmetry). Also electrodermal recordings (skin conductance) will be collected to obtain assessments of sympathetically-driven autonomic arousal.

In accordance to the GAAO account, it is hypothesized that OT will reduce avoidance-related motivational tendencies (assessed behaviorally and using EEG), irrespective of sociality (i.e. similar effect towards social and non-social stimuli).

In accordance to prior research, skin conductance responses are hypothesized to reduce after OT, indicating reduced sympathetically-driven autonomic arousal. On the other hand, considering the implicated role of sympathetic arousal in orienting responses, OT might also facilitate an enhancement of skin conductance responses, i.e., being reflective of OT's role in enhancing salience toward emotionally-evocative stimuli.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Leuven, Belgium, 3000
        • KU Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • right-handed
  • male
  • age between 18 and 35
  • Normal or adjusted-to-normal vision (with lenses only)
  • Dutch as mother tongue

Exclusion Criteria:

  • female
  • age below 18 or above 35
  • neurological or psychiatric condition (e.g. epilepsy, stroke, concussion), (e.g. anxiety disorder, depression)
  • use of psychotropic medication (e.g. anxiolytics, antidepressants)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Oxytocin
Syntocinon nasal spray (40 IU/ml; oxytocin, product code RVG 03716); single intranasal dose of 24 international units (IU; 3 puffs of 4 IU per nostril)
Syntocinon nasal spray
PLACEBO_COMPARATOR: Placebo
Saline natriumchloride solution nasal spray; single intranasal dose (3 puffs per nostril)
Placebo nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in EEG frontal alpha asymmetry after nasal spray administration
Time Frame: Average over trials, baseline and approximately 30 minutes after nasal spray administration
The influence of oxytocin administration on EEG frontal alpha asymmetry
Average over trials, baseline and approximately 30 minutes after nasal spray administration
Change in behavioral approach-avoidance (number of up or down key presses, prolonging or shortening the viewing time towards presented stimuli)
Time Frame: Average over trials, baseline and approximately 30 minutes after nasal spray administration

During the presentation of a series of stimuli, participants will be able to prolong or shorten the viewing time towards the presented stimuli, by pressing an 'up' or 'down' key on a keyboard. The number of up versus down key-presses will be taken as a measure of behavioral approach-avoidance.

The influence of oxytocin administration on the number of up or down key presses will be assessed.

Average over trials, baseline and approximately 30 minutes after nasal spray administration
Change in skin conductance (type of electrodermal recording) after nasal spray administration
Time Frame: Average over trials, baseline and approximately 30 minutes after nasal spray administration
The influence of oxytocin adminstration on skin conductance
Average over trials, baseline and approximately 30 minutes after nasal spray administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 15, 2018

Primary Completion (ACTUAL)

January 30, 2020

Study Completion (ACTUAL)

January 30, 2020

Study Registration Dates

First Submitted

June 17, 2020

First Submitted That Met QC Criteria

June 19, 2020

First Posted (ACTUAL)

June 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 23, 2020

Last Update Submitted That Met QC Criteria

June 19, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

De-identified individual participant data will be made availabe to other researchers upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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