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Oral Oxytocin's Effects on Attention Control

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

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.

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

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)




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04493515


Contacts
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Contact: Zhuang Qian, MD 13086663679 zq19910362@126.com
Contact: Xu Xiaolei, PhD 18780140034 rabby_uestc@outlook.com

Locations
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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
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Principal Investigator: Keith Kendrick, PhD University of Electronic Science and Technology of China (UESTC)
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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    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs