Oral Oxytocin's Effects on Attention Control

• ClinicalTrials.gov Identifier: NCT04493515
• Recruitment Status: Unknown
• First Posted: July 30, 2020
• Last Update Posted: July 30, 2020
• Sponsor: University of Electronic Science and Technology of China
• Information provided by (Responsible Party): Keith Kendrick, University of Electronic Science and Technology of China

Study Description

Brief Summary:

The main aim of the study is to investigate whether orally administered oxytocin (24IU) could modulate attention control using a social-emotional saccade/antisaccade eye-tracking paradigm.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Oral Oxytocin; Drug: Oral Placebo	Not Applicable

Detailed Description:

Numerous studies have reported the effect of intranasally administered oxytocin on attentional processing including stimulus-driven bottom-up processing and top-down goal-directed inhibitory control. However, it is unclear whether the functional effects are mediated by the peptide directly entering the brain or indirectly via raising peripheral concentrations. One possible method of producing a similar pattern of increased peripheral oxytocin concentrations but without the possibility of direct entry into the brain would be to administer the peptide lingually. In the present double-blind, between-subject, placebo-controlled study, 80 healthy male subjects will be recruited and receive either oxytocin (24IU) or placebo control administered orally (lingual). 45 minutes after treatment subjects are required to complete a social-emotional saccade/antisaccade eye-tracking paradigm. This paradigm uses social (happy, sad, angry, fear, and neutral faces) as well as non-social (oval shapes) stimuli to explore social- and emotion-specific effects of orally administered oxytocin.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Between-subject randomized placebo-controlled double-blind pharmacological eye-tracking design
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Oral Oxytocin's Effects on Attention Control: An Eye-tracking Study
• Actual Study Start Date: July 28, 2020
• Estimated Primary Completion Date: December 31, 2020
• Estimated Study Completion Date: December 31, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Oral Oxytocin; Oxytocin orally (24 IU)	Drug: Oral Oxytocin; Administration of oxytocin orally (24 IU)
Placebo Comparator: Oral Placebo; Placebo orally (24 IU, identical ingredients, except the active agent)	Drug: Oral Placebo; Administration of placebo orally (24 IU)

Outcome Measures

Primary Outcome Measures :

1. Effect of oral oxytocin administration on saccade/antisaccade latencies towards social (facial) versus non-social (shape) stimuli [ Time Frame: 45 minutes - 100 minutes after treatment ]
   Comparison between social-specific saccade/antisaccade latencies (in milliseconds) between the oxytocin and placebo treatment conditions
2. Effect of oral oxytocin administration on error rates of saccade/antisaccade for social (facial) versus non-social (shape) stimuli [ Time Frame: 45 minutes - 100 minutes after treatment ]
   Comparison between social-specific error rates of saccade/antisaccade between the oxytocin and placebo treatment conditions.

Secondary Outcome Measures :

1. Emotion-specific effects of oral oxytocin administration on saccade/antisaccade latencies towards the separate facial emotions [ Time Frame: 45 minutes - 100 minutes after treatment ]
   Comparison between emotion-specific saccade/antisaccade latencies (in milliseconds) between the oxytocin and placebo treatment conditions
2. Emotion-specific effects of oral oxytocin administration on saccade/antisaccade error rates for the separate facial emotions [ Time Frame: 45 minutes - 100 minutes after treatment ]
   Comparison between emotion-specific saccade/antisaccade error rates between the oxytocin and placebo treatment conditions

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 30 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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 oxytocin
• Contra-indications for eye-tracking data acquisition

Contacts and Locations

Contacts

Contact: Zhuang Qian, MD; 13086663679; zq19910362@126.com

Contact: Xu Xiaolei, PhD; 18780140034; rabby_uestc@outlook.com

Locations

China, Sichuan

University of Electronic Science and Technology of China(UESTC); Recruiting

Chengdu, Sichuan, China, 611731

Contact: Zhao Weihua, PhD +86 2861 830 811 zarazhao.uestc@outlook.com

Sponsors and Collaborators

University of Electronic Science and Technology of China

Investigators

• Principal Investigator: Keith Kendrick, PhD; University of Electronic Science and Technology of China (UESTC)

More Information

• Responsible Party: Keith Kendrick, Professor, University of Electronic Science and Technology of China
• ClinicalTrials.gov Identifier: NCT04493515
• Other Study ID Numbers: UESTC-neuSCAN-69
• First Posted: July 30, 2020
• Last Update Posted: July 30, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Oxytocin; Oxytocics; Reproductive Control Agents; Physiological Effects of Drugs