Social Safety Learning in the Brain Oxytocin System

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Social Safety Learning in the Brain Oxytocin System

Conditions
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Social Phobia

Intervention / Treatment
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* Drug: Oxytocin nasal spray


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinical<br>This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive either an oxytocin or placebo administration (blind randomization). | Drug: Oxytocin nasal spray<br>* Single acute administration of 24 international units (IU) oxytocin<br>|
| Placebo Comparator: Controls<br>This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive either an oxytocin or placebo administration (blind randomization). | Drug: Oxytocin nasal spray<br>* Single acute administration of 24 international units (IU) oxytocin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neural responses (e.g., regional brain activation in the ventromedial prefrontal cortex (vmPFC) to vicariously extinguished cue versus vicariously reinforced cue during reinstatement | vmPFC blood oxygen level dependent (BOLD) responses for non-reinforced conditioned stimulus (CS-) versus reinforced conditioned stimulus (CS+) | immediately after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin conductance responses (SCR) to vicariously extinguished cue versus vicariously reinforced cue during reinstatement | mean SCR for CS- versus CS+ | immediately after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social Phobia, Social Anxiety Disorder, Social Safety Learning, Intranasal Oxytocin