CompletedPhase 2

Social Safety Learning in the Brain Oxytocin System

United States121 participantsStarted 2023-06-26

Plain-language 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).

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Neural Responses in the CS+R vs CS+S Contrast in the Insula During the Extinction Phase

Timeframe: immediately (45 minutes) after receiving drug

Neural Responses in the CS+R vs CS+S Contrast in the Hippocampus During the Extinction Phase

Timeframe: immediately (45 minutes) after receiving drug

Neural Responses in the CS+R vs CS+S Contrast in the Anterior Cingulate Cortex During the Extinction Phase

Timeframe: immediately (45 minutes) after receiving drug

Neural Responses in the CS+R vs CS+S Contrast in the Ventromedial Prefrontal Cortex During the Extinction Phase

Timeframe: immediately (45 minutes) after receiving drug

Neural Responses in the CS+R vs CS+S Contrast in the Anterior Cingulate Cortex During the Reinstatement Phase

Timeframe: immediately (45 minutes) after receiving drug

Neural Responses in the CS+R vs CS+S Contrast in the Insula During the Reinstatement Phase

Timeframe: immediately (45 minutes) after receiving drug

Trial details

NCT IDNCT05968651

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-30

Results submitted2025-12-06

View on ClinicalTrials.gov More Social Phobia trials

Plain-language summary

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Neural Responses in the CS+R vs CS+S Contrast in the Insula During the Extinction Phase

Timeframe: immediately (45 minutes) after receiving drug

Neural Responses in the CS+R vs CS+S Contrast in the Hippocampus During the Extinction Phase

Timeframe: immediately (45 minutes) after receiving drug

Neural Responses in the CS+R vs CS+S Contrast in the Anterior Cingulate Cortex During the Extinction Phase

Timeframe: immediately (45 minutes) after receiving drug

Neural Responses in the CS+R vs CS+S Contrast in the Ventromedial Prefrontal Cortex During the Extinction Phase

Timeframe: immediately (45 minutes) after receiving drug

Neural Responses in the CS+R vs CS+S Contrast in the Anterior Cingulate Cortex During the Reinstatement Phase

Timeframe: immediately (45 minutes) after receiving drug

Neural Responses in the CS+R vs CS+S Contrast in the Insula During the Reinstatement Phase

Timeframe: immediately (45 minutes) after receiving drug