Back to resultsSocial Safety Learning in the Brain Oxytocin System
Primary Purpose
Social Phobia
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oxytocin nasal spray
Sponsored by
About this trial
This is an interventional treatment trial for Social Phobia focused on measuring Social Phobia, Social Anxiety Disorder, Social Safety Learning, Intranasal Oxytocin
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
Sites / Locations
- University of WashingtonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Clinical
Controls
Arm 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).
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).
Outcomes
Primary Outcome Measures
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+)
Secondary Outcome Measures
skin conductance responses (SCR) to vicariously extinguished cue versus vicariously reinforced cue during reinstatement
mean SCR for CS- versus CS+
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05968651
Brief Title
Social Safety Learning in the Brain Oxytocin System
Official Title
Social Safety Learning in the Brain Oxytocin System
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2023 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Phobia
Keywords
Social Phobia, Social Anxiety Disorder, Social Safety Learning, Intranasal Oxytocin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Clinical
Arm Type
Experimental
Arm 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).
Arm Title
Controls
Arm Type
Placebo Comparator
Arm 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).
Intervention Type
Drug
Intervention Name(s)
Oxytocin nasal spray
Intervention Description
Single acute administration of 24 international units (IU) oxytocin
Primary Outcome Measure Information:
Title
neural responses (e.g., regional brain activation in the ventromedial prefrontal cortex (vmPFC) to vicariously extinguished cue versus vicariously reinforced cue during reinstatement
Description
vmPFC blood oxygen level dependent (BOLD) responses for non-reinforced conditioned stimulus (CS-) versus reinforced conditioned stimulus (CS+)
Time Frame
immediately after the intervention
Secondary Outcome Measure Information:
Title
skin conductance responses (SCR) to vicariously extinguished cue versus vicariously reinforced cue during reinstatement
Description
mean SCR for CS- versus CS+
Time Frame
immediately after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Crane
Phone
206-221-1278
Email
jcrane2@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Fang, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Sarkisova, B.S.
Phone
206-221-1278
Email
msark@uw.edu
12. IPD Sharing Statement
Learn more about this trial
Social Safety Learning in the Brain Oxytocin System
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