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

Not Applicable

• Conditions: Healthy
• Interventions: Drug: oral lollipop with oxytocin (24IU); Drug: oral lollipop with placebo

• Registration Number: NCT05444738
• Lead Sponsor: University of Electronic Science and Technology of China

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.

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-06-20
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-04
• Last Update Submitted: 2022-07-04
• Study First Posted: 2022-07-06
• Last Update Posted: 2022-07-06
• Primary Completion: 2022-07-30
• Study Completion: 2022-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral oxytocin	oral lollipop with oxytocin (24IU)	oral lollipop with oxytocin (24IU)
oral lollipop with placebo	oral lollipop with placebo	Placebo orally (identical ingredients, except the active agent)

Primary Outcome Measures

Name	Time	Method
Oral oxytocin effect on error rates of saccade/anti-saccade to social (faces) and non-social (shape) cues between the oxytocin and placebo groups.	45minutes ~ 100 minutes after oral lollipop	A mixed ANOVA to compare differences in error rates in saccade/anti-saccade to different conditions (social/non-social) between two treatment groups.
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.	45minutes ~ 100 minutes after oral lollipop	A mixed ANOVA to compare differences of latencies (in milliseconds) in saccade/anti-saccade to different conditions (social/non-social) between two treatment groups.

Secondary Outcome Measures

Name	Time	Method
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	The Positive Affect Negative Affect Scale (PANAS) measures both positive and negative emotions in a person. The Positive Affect score range from 10-50, with higher scores representing higher levels of positive affect. The Negative Affect scores range from 10-50, with lower scores representing lower levels of negative affect.; The differences in PANAS scores in pre-/post-experiment between treatment groups will be analyzed using mixed ANOVA.
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	The State-Trait Anxiety Inventory (STAI) is a commonly used measure of the trait (TAI) and state (SAI) anxiety. Each type of anxiety has its own scale of 20 different questions that are scored, and scores range from 20-80, with higher scores indicating greater anxiety.; Differences in state anxiety (SAI) scores in pre-/post-experiment between treatment groups will be analyzed using mixed ANOVA.
Plasma oxytocin concentrations (pg/ml) before (basal) and 30 minutes after oral oxytocin or placebo administration.	30 minutes after oral lollipop	Differences in plasma oxytocin concentrations between the two treatment groups before and after the oral administration will be analyzed using mixed ANOVA, with time point and treatment group as independent variables.
Associations between plasma oxytocin concentration changes and task performance (error rates, latencies), mood (PANAS), and state anxiety (SAI).	45minutes ~ 100 minutes after oral lollipop	Pearson or Spearman correlation analysis between plasma oxytocin concentration changes (%) and error rates (%).; Pearson or Spearman correlation analysis between plasma oxytocin concentration changes (%) and latencies in milliseconds.; Pearson or Spearman correlation analysis between plasma oxytocin concentration changes (%) and post-task PANAS scores.; Pearson or Spearman correlation analysis between plasma oxytocin concentration changes (%) and post-task SAI scores.
Comparison between the effects of oxytocin administered intranasally, lingually, and orally on anti-saccade errors (%) by mixed ANOVA.	45minutes ~ 100 minutes after oral lollipop	Comparisons between anti-saccade errors in the current oral oxytocin administration experiment and those in previous ones using intranasal and lingual oxytocin administration (NCT03486925 and NCT04493515) will be made using mixed ANOVAs, with route (intranasal/lingual/oral) and treatment (oxytocin/placebo) as between-subject factors, condition (social/non-social) as within-subject factor.
Comparison between the effects of oxytocin administered intranasally, lingually, and orally on latencies in milliseconds by mixed ANOVA.	45minutes ~ 100 minutes after oral lollipop	Comparisons between anti-saccade latencies (in milliseconds) in the current oral oxytocin administration experiment and those in previous ones using intranasal and lingual oxytocin administration (NCT03486925 and NCT04493515) will be made using mixed ANOVAs, with route (intranasal/lingual/oral) and treatment (oxytocin/placebo) as between-subject factors, condition (social/non-social) as within-subject factor.
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.	45minutes ~ 100 minutes after oral lollipop	The State-Trait Anxiety Inventory (STAI) measures both trait (TAI) and state (SAI) anxiety. Each type of anxiety has its own scale of 20 different questions that are scored, and scores range from 20-80, with higher scores indicating greater anxiety.; Comparisons between changes of state anxiety (SAI) in the current oral oxytocin administration experiment and those in previous ones using intranasal and lingual oxytocin administration (NCT03486925 and NCT04493515) will be made using mixed ANOVAs, with route (intranasal/lingual/oral) and treatment (oxytocin/placebo) as between-subject factors, condition (social/non-social) as within-subject factor.; changes = (post-task SAI scores - pre-task SAI scores).

Trial Locations

Locations (1)

School of Life Science and Technolog; 🇨🇳 Chengdu, Sichuan, China