The Effects of Intranasal and Oral Administration of Oxytocin on Responses to Emotional Scenes

Differential Modulation of Neural and Behavioral Responses to Emotional Scenes by Intranasal and Oral Oxytocin Administration in Healthy Men

The study will investigate whether oxytocin administered either intranasally or orally (lingual) (24 international units, IU) can differentially modulate men's neural and behavioral responses to emotional scenes using an implicit emotional paradigm.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Oral Oxytocin; Drug: Intranasal Oxytocin; Drug: Oral placebo; Drug: Intranasal placebo

Detailed Description

Previous studies have reported that oxytocin administration intranasally and orally (spray on the tongue) can modulate neural and behavioral responses during processing of face emotions and can influence top-down attention to social stimuli. However, no research has directly compared the neural and behavioral effects of the two different administration routes on the processing of emotional scenes. In the current randomized, double-blind, between-subjects, placebo-controlled study, 160 healthy male subjects will be recruited and receive treatment either oxytocin (24IU, orally/intranasally) or placebo (orally/intranasally). Prior to treatment, all subjects will complete a number of questionnaires to control for potential group differences in potential confounders in terms of personality traits and mood, including: Beck Depression Inventory-II (BDI), Autism Spectrum Quotient (ASQ), Liebowitz Social Anxiety Scale (LSAS), State-Trait Anxiety Inventory (STAI), Childhood Trauma Questionnaire (CTQ), Interpersonal Reactivity Index (IRI). Additionally, the Positive and Negative Affect Schedule (PANAS) is administered before the treatment and before and after completing the implicit emotional scanning task to measure any changes in mood. Forty-five minutes after receiving treatment, subjects will be required to undergo and MRI scanning session including structural scans and resting-state fMRI followed by an implicit emotional scene processing task (picture source: Nencki affective picture system, including positive, neutral, and negative-valence social and non-social scenes). After fMRI scanning, subjects will be required to rate emotional stimuli presented during the scan on valence, intensity, and arousal using 1-9 point Self-Assessment Manikin (SAM) scales.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 611731
      • Recruiting
      • School of Life science and Technology, University of Electronic Science and Technology of China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 26 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oral Oxytocin; Administer oxytocin (24 IU) orally	Drug: Oral Oxytocin; Administer oxytocin (24 IU) orally, 6 individual 0.1 ml puffs (4 IU/0.1ml) on the tongue (lingual), one every 30 seconds; Other Names: Oxytocin orally
Active Comparator: Intranasal Oxytocin; Administer oxytocin (24 IU) intranasally	Drug: Intranasal Oxytocin; Administer oxytocin (24 IU) intranasally, 6 individual 0.1 ml puffs (4 IU/0.1ml), three puffs per nostril one every 30 seconds; Other Names: Oxytocin intranasally
Placebo Comparator: Oral placebo; Administer placebo orally (identical ingredients, except the active agent)	Drug: Oral placebo; Administer placebo orally, 6 individual 0.1 ml puffs on the tongue (lingual), one every 30 seconds.; Other Names: Placebo orally
Placebo Comparator: Intranasal placebo; Administer placebo intranasally (identical ingredients, except the active agent)	Drug: Intranasal placebo; Administer placebo intranasally, 6 individual 0.1 ml puffs, three puffs per nostril one every 30 seconds; Other Names: Placebo intranasally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the effects of oxytocin on neural responses to emotional scenes between intranasal and oral administration routes.	Comparison of whole brain neural (fMRI scanning) activation differences between oral and intranasal oxytocin administration to emotional scenes will be performed using a mixed ANOVA with route (oral/intranasal), treatment (oxytocin/placebo) as between subject factors and valence of emotional scenes (positive/negative/neutral) as within-subject factor, post-hoc comparisons will be conducted to further disentangle the significant interactions observed after the mixed ANOVA.	45~70 minutes after treatment
Compare the effects of oxytocin on behavioral responses to emotional scenes between intranasal and oral administration routes.	Differences in behavioral ratings of valence (1-9 point Self-Assessmen-Manikin (SAM) scale, 1 means very negative, 9 means very positive, 5 means neutral), intensity (1-9 point SAM scale, 1 means mild, 9 means strong), and arousal (1-9 point SAM scale, 1 means not aroused at all, 9 means very aroused) of emotional scene stimuli between oral oxytocin and intranasal oxytocin groups will be examined using mixed ANOVAs, respectively.	70~90 minutes after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the effect of oxytocin on neural functional connectivity during processing of emotional scenes between intranasal and oral administration routes.	Comparison of functional connectivity (fMRI scanning) differences between oral and intranasal oxytocin administration to emotional scenes by means of a mixed ANOVA with route (oral/intranasal), treatment (oxytocin/placebo) as between subject factors and emotional scene (positive/negative/neutral) as within-subject factor, post-hoc comparisons was conducted to further disentangle the significant interaction observed after mixed ANOVA.	45~70 minutes after treatment
Correlations between neural activation and behavioral effects of intranasal or oral oxytocin during emotional scene processing.	Pearson correlation tests will be used to compute correlations between any significant neural and behavioral effects of treatment.	45~90 minutes after treatment
Correlations between functional connectivity and behavioral effects of intranasal or oral oxytocin during emotional scene processing.	Pearson correlation tests will be used to compute correlations between any significant neural and behavioral effects of treatment.	45~90 minutes after treatment
Comparison of effects of oxytocin on pre-task resting-state functional connectivity (rsfMRI) between intranasal and oral administration routes.	Comparisons of whole brain rsfMRI will be performed using an ANOVA with route (oral/intranasal) and treatment (oxytocin/placebo) as between-subject factors. Post-hoc comparisons will be used to disentangle significant interactions observed in the ANOVA.	45~70 minutes after treatment
Mood changes assessed by the Positive Affect Negative Affect Schedule (PANAS) in all treatment groups during the experiment.	The Positive Affect Negative Affect Schedule measures both positive and negative mood in a person. The Positive Affect score ranges 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 at each time-point between treatment groups will be analyzed using mixed ANOVAs.	0~70 minutes

Collaborators and Investigators

• Sponsor: University of Electronic Science and Technology of China

Study record dates

Study Major Dates

• Study Start (Anticipated): September 20, 2022
• Primary Completion (Anticipated): December 20, 2022
• Study Completion (Anticipated): February 20, 2023

Study Registration Dates

• First Submitted: September 4, 2022
• First Submitted That Met QC Criteria: September 4, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 4, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Oxytocin; Intranasal; Oral; Emotional processing
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: UESTC-neuSCAN-91

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No