Clinical trial NCT05968651: Social Safety Learning in the Brain Oxytocin System
Official title: Social Safety Learning in the Brain Oxytocin System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Social Phobia
Keywords: Social Phobia
Social Anxiety Disorder
Social Safety Learning
Intranasal Oxytocin
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: neural responses (e.g., regional brain activation in the ventromedial prefrontal cortex (vmPFC) to vicariously extinguished cue versus vicariously reinforced cue during reinstatement
timeFrame: immediately after the intervention
Secondary outcomes:
measure: skin conductance responses (SCR) to vicariously extinguished cue versus vicariously reinforced cue during reinstatement
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Angela Fang, PhD
role: PRINCIPAL_INVESTIGATOR
References: