RECRUITING

Intranasal Insulin for Posttraumatic Stress Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Intranasal Insulin for Treating Posttraumatic Stress Disorder

Quick Facts

Study Start:2024-10-31

Study Completion:2025-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04044534

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Male or female, 21-65 years old * Current PTSD * Able to provide written informed consent	* 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

Inclusion Criteria

Exclusion Criteria

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

* 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

Contacts and Locations

Study Contact

Gihyun Yoon, MD

CONTACT

(203) 932-5711

gihyun.yoon@yale.edu

Principal Investigator

Gihyun Yoon, MD

PRINCIPAL_INVESTIGATOR

VA Connecticut Healthcare System

Study Locations (Sites)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516

United States

Collaborators and Investigators

Sponsor: VA Connecticut Healthcare System

Gihyun Yoon, MD, PRINCIPAL_INVESTIGATOR, VA Connecticut Healthcare System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-31

Study Completion Date2025-05-31

Study Record Updates

Study Start Date2024-10-31

Study Completion Date2025-05-31

Terms related to this study

Keywords Provided by Researchers

Intranasal insulin
PTSD

Additional Relevant MeSH Terms

PTSD