Effects of Oxytocin Administered Orally Using a Medicated Lollipop on Peripheral Concentrations and Attention

NCT05444738 | Unknown

• 1 other identifier: UESTC-neuSCAN-86
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The study will investigate whether oxytocin (24IU) administered orally using medicated lollipops results in increased peripheral oxytocin concentrations and can modulate social attention in an anti-saccade paradigm in the same way as when it is administered by intranasal or lingual routes.

Conditions

Healthy

Keywords

social salience; oral oxytocin; antisaccade paradigm; attention

Outcome Measures

Primary Outcomes (2)

• Oral oxytocin effect on error rates of saccade/anti-saccade to social (faces) and non-social (shape) cues between the oxytocin and placebo groups.

  A mixed ANOVA to compare differences in error rates in saccade/anti-saccade to different conditions (social/non-social) between two treatment groups.

  45minutes ~ 100 minutes after oral lollipop

• Oral oxytocin effect on latencies (in milliseconds) of saccade/anti-saccade to social (faces) and non-social (shape) cues between the oxytocin and placebo groups.

  A mixed ANOVA to compare differences of latencies (in milliseconds) in saccade/anti-saccade to different conditions (social/non-social) between two treatment groups.

  45minutes ~ 100 minutes after oral lollipop

Secondary Outcomes (7)

• Plasma oxytocin concentrations (pg/ml) before (basal) and 30 minutes after oral oxytocin or placebo administration.

  30 minutes after oral lollipop

• Change of Mood as assessed by the Positive Affect Negative Affect Scale (PANAS) before and after the experiment in two treatment groups.

  45minutes ~ 100 minutes after oral lollipop

• Change of state anxiety as assessed by the State-Trait Anxiety Inventory (STAI) before and after the experiment in two treatment groups.

  45minutes ~ 100 minutes after oral lollipop

• Associations between plasma oxytocin concentration changes and task performance (error rates, latencies), mood (PANAS), and state anxiety (SAI).

  45minutes ~ 100 minutes after oral lollipop

• Comparison between the effects of oxytocin administered intranasally, lingually, and orally on anti-saccade errors (%) by mixed ANOVA.

  45minutes ~ 100 minutes after oral lollipop

Study Arms (2)

oral oxytocin

EXPERIMENTAL

oral lollipop with oxytocin (24IU)

Drug: oral lollipop with oxytocin (24IU)

oral lollipop with placebo

PLACEBO COMPARATOR

Placebo orally (identical ingredients, except the active agent)

Drug: oral lollipop with placebo

Interventions

oral lollipop with oxytocin (24IU) DRUG

Immediately before drug administration, a blood sample (5ml) is collected. For drug administration, participants will be instructed to suck the lollipop medicated with 24IU oxytocin for 3 minutes and then to sit relaxed in a quiet room for 30 minutes prior to taking another blood sample (5ml). Participants then start the anti-saccade attention task 45 minutes after drug administration.

Also known as: oral oxytocin

oral oxytocin

oral lollipop with placebo DRUG

Immediately before drug administration, a blood sample (5ml) is collected. For placebo administration, participants will be instructed to suck the placebo lollipop for 3 minutes and then to sit relaxed in a quiet room for 30 minutes prior to taking another blood sample (5ml). Participants then start the anti-saccade attention task 45 minutes after placebo administration.

Also known as: oral placebo

oral lollipop with placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects without any past or present psychiatric or neurological disorders

You may not qualify if:

• History of brain injury
• Head trauma
• Substance abuse
• Medication

Sponsors & Collaborators

• University of Electronic Science and Technology of China: lead

Study Sites (1)

School of Life Science and Technolog

Chengdu, Sichuan, 611731, China

RECRUITING

Related Publications (2)

• Xu X, Li J, Chen Z, Kendrick KM, Becker B. Oxytocin reduces top-down control of attention by increasing bottom-up attention allocation to social but not non-social stimuli - A randomized controlled trial. Psychoneuroendocrinology. 2019 Oct;108:62-69. doi: 10.1016/j.psyneuen.2019.06.004. Epub 2019 Jun 15.

  PMID: 31229634 BACKGROUND

• Zhuang Q, Zheng X, Yao S, Zhao W, Becker B, Xu X, Kendrick KM. Oral Administration of Oxytocin, Like Intranasal Administration, Decreases Top-Down Social Attention. Int J Neuropsychopharmacol. 2022 Nov 17;25(11):912-923. doi: 10.1093/ijnp/pyac059.

  PMID: 36053298 BACKGROUND

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Keith M Kendrick, PhD

  University of Electronic Science and Technology of China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keith M Kendrick, PhD

CONTACT

86-28-61830811; k.kendrick.uestc@gmail.com

Weihua Zhao, PhD

CONTACT

86-28-61830811; zarazhao.uestc@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Inverstigator

Model Details: Randomized placebo-controlled triple-blind between-subject design

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: July 6, 2022
• Study Start: April 1, 2022
• Primary Completion: July 30, 2022
• Study Completion: August 30, 2022
• Last Updated: July 6, 2022

Record last verified: 2022-07

Locations

CN (1)