Social Safety Learning in the Brain Oxytocin System

NCT05968651 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: STUDY00013670
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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).

Conditions

Social Phobia

Keywords

Social Phobia; Social Anxiety Disorder; Social Safety Learning; Intranasal Oxytocin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• skin conductance responses (SCR) to vicariously extinguished cue versus vicariously reinforced cue during reinstatement

  immediately after the intervention

Study Arms (2)

Clinical

EXPERIMENTAL

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

Controls

PLACEBO COMPARATOR

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

Interventions

Oxytocin nasal spray DRUG

Single acute administration of 24 international units (IU) oxytocin

Clinical; Controls

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Angela Fang, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Psychology

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: August 1, 2023
• Study Start: June 26, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)