Clinical trial NCT05444738: Effects of Oxytocin Administered Orally Using a Medicated Lollipop on Peripheral Concentrations and Attention
Official title: Efficacy of Administering Oxytocin Orally Using a Medicated Lollipop Approach on Peripheral Concentrations and Attention: Comparisons With Intranasal and Lingual Spray Administration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: social salience
oral oxytocin
antisaccade paradigm
attention
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized placebo-controlled triple-blind between-subject design
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Oral oxytocin effect on error rates of saccade/anti-saccade to social (faces) and non-social (shape) cues between the oxytocin and placebo groups.
timeFrame: 45minutes ~ 100 minutes after oral lollipop
measure: 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.
timeFrame: 45minutes ~ 100 minutes after oral lollipop
Secondary outcomes:
measure: Plasma oxytocin concentrations (pg/ml) before (basal) and 30 minutes after oral oxytocin or placebo administration.
timeFrame: 30 minutes after oral lollipop
measure: Change of Mood as assessed by the Positive Affect Negative Affect Scale (PANAS) before and after the experiment in two treatment groups.
timeFrame: 45minutes ~ 100 minutes after oral lollipop
measure: Change of state anxiety as assessed by the State-Trait Anxiety Inventory (STAI) before and after the experiment in two treatment groups.
timeFrame: 45minutes ~ 100 minutes after oral lollipop
measure: Associations between plasma oxytocin concentration changes and task performance (error rates, latencies), mood (PANAS), and state anxiety (SAI).
timeFrame: 45minutes ~ 100 minutes after oral lollipop
measure: Comparison between the effects of oxytocin administered intranasally, lingually, and orally on anti-saccade errors (%) by mixed ANOVA.
timeFrame: 45minutes ~ 100 minutes after oral lollipop
measure: Comparison between the effects of oxytocin administered intranasally, lingually, and orally on latencies in milliseconds by mixed ANOVA.
timeFrame: 45minutes ~ 100 minutes after oral lollipop
measure: Comparison between the effects of oxytocin administered intranasally, lingually, and orally in state anxiety (measured by the State-Trait Anxiety Inventory) changes by mixed ANOVA.
timeFrame: 45minutes ~ 100 minutes after oral lollipop
Other outcomes:
Locations:
city: Chengdu
country: China
facility: School of Life Science and Technolog
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Keith M Kendrick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.