Social Safety Learning in the Brain Oxytocin System

Social Phobia Clinical Trial

Official title:

Social Safety Learning in the Brain Oxytocin System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05968651
• Other study ID #: STUDY00013670
• Status: Recruiting
• Phase: Phase 2
• Start date: June 26, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: July 2023
• Source: University of Washington
• Contact: Jessica Crane
• Phone: 206-221-1278
• Email: jcrane2[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Phobia, Social
• Social Phobia

Intervention

Drug:
• Oxytocin nasal spray
Single acute administration of 24 international units (IU) oxytocin

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	skin conductance responses (SCR) to vicariously extinguished cue versus vicariously reinforced cue during reinstatement	mean SCR for CS- versus CS+	immediately after the intervention