RecruitingPhase 2NCT04044534

Intranasal Insulin for Posttraumatic Stress Disorder

Intranasal Insulin for Treating Posttraumatic Stress Disorder


Sponsor

VA Connecticut Healthcare System

Enrollment

20 participants

Start Date

Oct 31, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate if intranasal insulin is effective in reducing PTSD symptoms.


Eligibility

Min Age: 21 YearsMax Age: 65 Years

Inclusion Criteria3

  • Male or female, 21-65 years old
  • Current PTSD
  • Able to provide written informed consent

Exclusion Criteria11

  • Unstable medical condition, clinically determined by a physician
  • Diabetes requiring insulin or oral hypoglycemic agents
  • Moderate-severe traumatic brain injury
  • Current psychotic disorder, bipolar disorder, cognitive disorder in the past 12 months
  • Current substance use disorders (except alcohol, tobacco, or cannabis) in the past 3 months
  • Changes in doses of psychotropic medications in the past 4 weeks
  • Initiation of individual therapy or counseling in the past 4 weeks
  • Imminent suicidal or homicidal risk
  • Contraindication to Insulin
  • History of claustrophobia
  • Presence of cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a standard pre-MRI safety screening questionnaire

Interventions

DRUGIntranasal insulin

Subjects in this arm will receive intranasal insulin (80 IU per day).

DRUGPlacebo

Subjects in this arm will receive placebo.


Locations(1)

VA Connecticut Healthcare System

West Haven, Connecticut, United States

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NCT04044534


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