Differential Effects of Oral and Intranasal Oxytocin on Attention Control

Study Overview
=================
Brief Summary
-----------------
The main aim of the present study is to investigate whether oxytocin (24IU) via different routes have divergent effects on attention control in a social-emotional saccade/antisaccade eye-tracking paradigm.

Detailed Description
-----------------
Previous studies have demonstrated oral and intranasal oxytocin's divergent effects on arousal rating and neural responses to emotional faces, however, it remains unclear whether different routes of oxytocin treatment would have differential effects on attention processing to social stimuli. Based on the previous registered studies (ClinicalTrials.gov ID: NCT04493515 and NCT03486925) from our group using a validated emotional anti-saccade task with social stimuli (emotional faces) and non-social stimuli (oval shape) have separately explored oral and intranasal oxytocin's modulatory effects on attention processing, the present study aims to conduct a secondary analysis of the previously acquired data to directly compare oxytocin's effects on attention control to social emotional stimuli via different routes. To this end data from subjects who underwent intranasal oxytocin administration (n = 33, NCT03486925) will be compared with data from subjects who underwent oral oxytocin or placebo administration (n = 36, or 37 respectively; NCT04493515). To further control for non-treatment related factors the intranasal placebo and oral placebo groups from the previous studies (ClinicalTrials.gov ID: NCT03486925 and NCT04493515) will be compared with respect to primary and secondary outcome measures of the trial, in particular general and emotion-specific effects on attentional control.

Official Title
-----------------
The Differential Effects of Oral and Intranasal Oxytocin on Attention Control

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Oxytocin
* Drug: Oxytocin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, healthy participants Non smokers Exclusion Criteria: Previous or current medical, psychiatric, neurological disorder Regular medication Use of any psychoactive substances in the 24 hours before experiment Contra-indications for eye-tracking data acquisition

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Between-subject randomized placebo-controlled double-blind pharmacological eye-tracking design
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Oxytocin<br>Oxytocin (24IU) orally | Drug: Oxytocin<br>* Administration of oxytocin (24IU) orally<br>|
| Experimental: Intranasal Oxytocin<br>Oxytocin (24IU) intranasally | Drug: Oxytocin<br>* Administration of oxytocin (24IU) intranasally<br>|
| Placebo Comparator: Oral Placebo<br>Placebo orally | Drug: Placebo<br>* Administration of placebo orally<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differential effects of intranasal and oral oxytocin administration on saccade/antisaccade latencies towards social (facial) versus non-social (shape) stimuli | Comparison between social-specific saccade/antisaccade latencies (in milliseconds) between the intranasal and oral oxytocin and placebo treatment conditions | 45 minutes - 100 minutes after treatment | 
| Differential effects of intranasal and oral oxytocin administration on error rates of saccade/antisaccade for social (facial) versus non-social (shape) stimuli | Comparison between social-specific error rates of saccade/antisaccade between the intranasal and oral oxytocin and placebo treatment conditions. | 45 minutes - 100 minutes after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotion-specific effects of intranasal and oral oxytocin administration on saccade/antisaccade latencies towards the separate facial emotions | Comparison between emotion-specific saccade/antisaccade latencies (in milliseconds) between the intranasal and oral oxytocin and placebo treatment conditions | 45 minutes - 100 minutes after treatment | 
| Emotion-specific effects of intranasal and oral oxytocin administration on saccade/antisaccade error rates for the separate facial emotions | Comparison between emotion-specific saccade/antisaccade error rates between the intranasal and oral oxytocin and placebo treatment conditions | 45 minutes - 100 minutes after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antisaccade task, Attention control, Oxytocin, Eye-tracking