Social Safety Learning in the Brain Oxytocin System

NCT ID: NCT05968651

Last Updated: 2024-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-26
• Study Completion Date: 2024-09-30

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.

Conditions

Social Phobia

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Clinical

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).

Group Type: EXPERIMENTAL

Oxytocin nasal spray

Intervention Type: DRUG

Single acute administration of 24 international units (IU) oxytocin

Controls

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).

Group Type: PLACEBO_COMPARATOR

Oxytocin nasal spray

Intervention Type: DRUG

Single acute administration of 24 international units (IU) oxytocin

Interventions

Oxytocin nasal spray

Single acute administration of 24 international units (IU) oxytocin

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Angela Fang

Assistant Professor, Department of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angela Fang, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

STUDY00013670

Identifier Type: -

Identifier Source: org_study_id