Social Safety Learning in the Brain Oxytocin System

University of Washington

Status and phase: Completed; Phase 2

Conditions: Social Phobia

Treatments: Drug: Oxytocin nasal spray

Study type: Interventional

Funder types: Other

Identifiers

NCT05968651

STUDY00013670

Details and patient eligibility

About

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).

Full 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.

Enrollment: 121 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

121 participants in 2 patient groups, including a placebo group

Clinical

Experimental group

Description:

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).

Treatment:

Drug: Oxytocin nasal spray

Controls

Placebo Comparator group

Description:

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).

Treatment:

Drug: Oxytocin nasal spray