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

NCT ID: NCT05444738

Last Updated: 2022-07-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2022-08-30

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.

Detailed Description

In a triple-blind, placebo-controlled experiment, 72 adult male subjects will be randomly allocated to either receive oral oxytocin (24IU - medicated lollipop - n = 36) or placebo (lollipop without oxytocin - n = 36). After treatment allocation, all subjects will first fill out a set of questionnaires as a control for potential confounders, including Beck Depression Inventory-II (BDI), State-Trait Anxiety Inventory (STAI), Autism Spectrum Quotient (ASQ), the Second Version of Social Responsiveness Scale (SRS-2), Childhood Trauma Questionnaire (CTQ), Toronto Alexithymia Scale (TAS), and Positive Affect Negative Affect Scale (PANAS). Immediately before and 30 minutes after oral treatment administration, subjects will have 5 ml blood samples taken for assay of oxytocin concentrations. Subjects will sit quietly and relax in between blood samples. After the second blood sample, subjects will be positioned sitting in front of an eye-tracking machine and briefly practicing the anti-saccade task. Subjects will then perform the full anti-saccade eye-tracking task, which includes both social (emotional faces - angry, fear, happy, sad, and neutral) and non-social (oval shapes or houses) stimuli (similar to previous studies using intranasal -see NCT03486925 and NCT04493515). After the task, subjects will be asked to guess which treatment they received, and their ability to do so analyzed using chi-squared. Treatment effects on primary (anti-saccade and pro-saccade errors and response latencies) outcomes will be analyzed using ANOVAs. In a secondary analysis, associations between primary outcome measures and basal and altered oxytocin concentrations will be analyzed using Pearson or Spearman correlations. Additionally, a comparison between the effects of oxytocin administered intranasally, lingually (using previously published data), and orally (medicated lollipop) on outcome measures will be analyzed using ANOVA.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

oral oxytocin

oral lollipop with oxytocin (24IU)

Group Type: EXPERIMENTAL

oral lollipop with oxytocin (24IU)

Intervention Type: 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.

oral lollipop with placebo

Placebo orally (identical ingredients, except the active agent)

Group Type: PLACEBO_COMPARATOR

oral lollipop with placebo

Intervention Type: 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.

Interventions

oral lollipop with oxytocin (24IU)

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.

Intervention Type: DRUG

oral lollipop with placebo

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.

Intervention Type: DRUG

Other Intervention Names

oral oxytocin; oral placebo

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

1. History of brain injury

2. Head trauma

3. Substance abuse

4. Medication

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Electronic Science and Technology of China

OTHER

Sponsor Role: lead

Responsible Party

Keith Kendrick

Principal Inverstigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Keith M Kendrick, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Electronic Science and Technology of China

Locations

School of Life Science and Technolog

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Keith M Kendrick, PhD

Role: CONTACT

k.kendrick.uestc@gmail.com

86-28-61830811

Weihua Zhao, PhD

Role: CONTACT

zarazhao.uestc@outlook.com

86-28-61830811

Facility Contacts

Weihua Zhao, PhD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 31229634 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36053298 (View on PubMed)

Other Identifiers

UESTC-neuSCAN-86

Identifier Type: -

Identifier Source: org_study_id