DRUG
Oxytocin nasal spray or placebo
Single acute administration of 24 international units (IU) oxytocin or matching placebo
Social Safety Learning in the Brain Oxytocin System
Status
Completed
Phase
Phase 2
Enrollment
121
Locations
1
Results
Posted
Publications
0
Study summary
What the protocol is testing.
The investigators are conducting this research study to examine whether oxytocin enhances social safety learning (learning safety through the experience of another individual) in people with social anxiety disorder (SAD) compared to healthy volunteers. Oxytocin is a hormone that can also act as a chemical messenger in the brain. Oxytocin plays a role in a number of functions, including responding to fear and social interactions. In this study, the investigators would like to compare the effects of oxytocin and placebo nasal sprays in adults with SAD and healthy adults. This research study will compare an oxytocin nasal spray to a placebo nasal spray. About 120 people will take part in this research study, all at the University of Washington (UW).
Full detailed description
The goal of the current study is to examine the potential role of oxytocin in enhancing social learning in SAD. The investigators' primary hypothesis is that vicarious extinction learning will contribute to safety learning and that oxytocin will potentiate vicarious extinction learning in patients with SAD, compared to healthy controls (HC). The investigators will directly test the effect of intranasal oxytocin and matching placebo on the brain mechanisms underlying vicarious extinction learning using a novel task. 60 adults with SAD and 60 healthy control participants will perform a task that involves three phases: (i) a standard social fear acquisition procedure while in a mock scanner, followed by (ii) a vicarious extinction and (iii) fear reinstatement test procedure, while being scanned during functional magnetic resonance imaging (fMRI). Participants will receive oxytocin or placebo prior to the extinction phase. The investigators will also measure skin conductance responses as an index of learning in each phase.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Aug 1, 2023
Study start
Jun 26, 2023
Primary completion
Sep 30, 2024
Study completion
Sep 30, 2024
Results posted
Jun 11, 2026
Registry updated
Jun 11, 2026
Outcomes
What the study measures.
Primary outcomes
Neural Responses in the CS+R vs CS+S Contrast in the Insula During the Extinction Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the insula during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the insula region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Neural Responses in the CS+R vs CS+S Contrast in the Hippocampus During the Extinction Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the hippocampus during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the hippocampus region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Neural Responses in the CS+R vs CS+S Contrast in the Anterior Cingulate Cortex During the Extinction Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the anterior cingulate cortex during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the anterior cingulate cortex region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Neural Responses in the CS+R vs CS+S Contrast in the Ventromedial Prefrontal Cortex During the Extinction Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the ventromedial prefrontal cortex during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the ventromedial prefrontal cortex region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Neural Responses in the CS+R vs CS+S Contrast in the Anterior Cingulate Cortex During the Reinstatement Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the anterior cingulate cortex during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the anterior cingulate cortex region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Neural Responses in the CS+R vs CS+S Contrast in the Insula During the Reinstatement Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the insula during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the insula region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Neural Responses in the CS+R vs CS+S Contrast in the Hippocampus During the Reinstatement Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the hippocampus during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the hippocampus region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Neural Responses in the CS+R vs CS+S Contrast in the Amygdala During the Reinstatement Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the amygdala during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the amygdala region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 45 Years
- Sex
- ALL
- Healthy volunteers
- Yes
Inclusion Criteria: For Clinical Sample * Men and women age 18-45 * Women must be having regular menstrual cycles and not be taking oral contraception * Primary diagnosis of social anxiety disorder For Healthy Sample * Men and women age 18-45 * Women must be having regular menstrual cycles and not be taking oral contraception * No current or lifetime history of psychiatric, neurological, or medical disorders Exclusion Criteria: For All Groups * Pregnancy or breastfeeding * Positive urine drug screening test result * History of nasal pathology * Current use of any psychotropic medication or steroids * Active substance use disorder within the past 6 months * History of serious medical illnesses or untreated endocrine diseases * History of head injury, neurological disorder, or neurosurgical procedure * Positive magnetic resonance (MR) screen For Clinical Sample * Lifetime diagnoses of mania or psychotic disorder based on the Diagnostic and Statistical Manual (DSM- 5th ed) * Acute suicidal ideation For Healthy Sample * Lifetime DSM-5 diagnosis of any medical, neurological, or psychiatric illness
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
University of Washington
Seattle, Washington, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
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