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Trial · Interventional

Status unknownNot applicableRegistry data

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

NCTNCT05444738 (opens ClinicalTrials.gov in a new tab)Other idUESTC-neuSCAN-86
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Overview

Status
Status unknown
Phase
Not applicable
Enrollment
72 participants (estimated)
Sponsor
University of Electronic Science and Technology of China · Other
Design
Randomized · Triple masking
Countries
1 country

China

Start
1 Apr 2022
Primary completion
30 Jul 2022 (estimated)
Completion
30 Aug 2022 (estimated)
First posted
6 Jul 2022
Last update posted
6 Jul 2022
Conditions
Healthy

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20222023
  1. N/A

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

    NCT05444738

    1 Apr 2022 to est. 30 Aug 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • oral lollipop with oxytocin (24IU)Drug
  • oral lollipop with placeboDrug

Arms2

  • Experimental

    oral oxytocin

    oral lollipop with oxytocin (24IU)

  • Placebo comparator

    oral lollipop with placebo

    Placebo orally (identical ingredients, except the active agent)

Primary outcomes2

Outcomes the sponsor listed as primary.

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

    Time frame · 45minutes ~ 100 minutes after oral lollipop

    Registry description

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

  2. 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.

    Time frame · 45minutes ~ 100 minutes after oral lollipop

    Registry description

    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 outcomes(7)

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

    Time frame · 30 minutes after oral lollipop

    Registry description

    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.

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

    Time frame · 45minutes ~ 100 minutes after oral lollipop

    Registry description

    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.

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

    Time frame · 45minutes ~ 100 minutes after oral lollipop

    Registry description

    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.

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

    Time frame · 45minutes ~ 100 minutes after oral lollipop

    Registry description

    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.

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

    Time frame · 45minutes ~ 100 minutes after oral lollipop

    Registry description

    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.

  6. Comparison between the effects of oxytocin administered intranasally, lingually, and orally on latencies in milliseconds by mixed ANOVA.

    Time frame · 45minutes ~ 100 minutes after oral lollipop

    Registry description

    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.

  7. 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.

    Time frame · 45minutes ~ 100 minutes after oral lollipop

    Registry description

    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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

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Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2019

3 results

Oxytocin reduces top-down control of attention by increasing bottom-up attention allocation to social but not non-social stimuli - A randomized controlled trial.

Xu et al. 2019Psychoneuroendocrinologycited by 39

PMID 31229634DOI 10.1016/j.psyneuen.2019.06.004PUB-31229634

Rights unknown3 results
Source linkSee results (3)

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 30 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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