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Hormone Therapy

Oxytocin Intranasal Spray 12 International Unit (IU) for Stress

Phase 2

Waitlist Available

Led By Soonjo Hwang, MD

Research Sponsored by University of Nebraska

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 min

Awards & highlights

Study Summary

This trial will test if a nasal spray called oxytocin can help improve the quality of life and reduce stress in caregivers of people with dementia. The study will involve 32 participants and will last for

Who is the study for?

This trial is for caregivers of individuals with dementia. Participants should be in good general health and able to undergo an MRI scan. Specific details about who can join are not provided, but typically there would be age limits and other health requirements.Check my eligibility

What is being tested?

The study tests if a nasal spray containing oxytocin (at two different doses: 12IU or 24IU) can improve life quality and reduce stress compared to a placebo. It's double-blind, meaning neither the researchers nor participants know who gets oxytocin or placebo.See study design

What are the potential side effects?

While specific side effects aren't listed here, intranasal oxytocin could potentially cause nasal irritation, headaches, changes in heart rate or blood pressure, emotional changes, or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 min

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 min

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 min for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Participants' chronic stress levels in the past thirty days.

Secondary outcome measures

Blood Oxygen Level Dependent (BOLD) responses in neural areas during the Affective Stroop task (AS) and EmpaTom task.

Participant Quality of Life survey

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Oxytocin Intranasal Spray 12 International Unit (IU)Active Control2 Interventions

Nasal spray of Oxytocin 12 International Unit (12IU) liquid solution as 2 puffs of daily dose (every morning) for 3 weeks. fMRI scan pre and post administration.

Group II: Oxytocin Intranasal Spray 24 International Unit (IU)Active Control2 Interventions

Nasal spray of Oxytocin 24 International Unit (12IU) liquid solution as 2 puffs of daily dose (every morning) for 3 weeks. fMRI scan pre and post administration.

Group III: Intranasal Spray PlaceboPlacebo Group2 Interventions

Nasal Spray of placebo liquid solution as 2 puffs of daily dose (every morning) for 3 weeks. fMRI scan pre and post-administration.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor

540 Previous Clinical Trials

1,144,726 Total Patients Enrolled

Soonjo Hwang, MDPrincipal InvestigatorUniversity of Nebraska

2 Previous Clinical Trials

118 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing efforts to enroll participants for this clinical trial at the moment?

"As per the information available on clinicaltrials.gov, the ongoing medical trial in question is not actively seeking volunteers. Despite being first posted on July 1st, 2024 and last updated on April 8th, 2024, this specific trial has currently paused recruitment efforts. However, it is noteworthy that there are a total of 554 alternative trials open for participant enrollment at present."

Answered by AI

What are the potential risks associated with using Oxytocin Intranasal Spray at a concentration of 12 International Units (IU)?

"In this Phase 2 trial, the safety of Oxytocin Intranasal Spray at a dose of 12 International Units (IU) is rated as a 2 by our team at Power. This denotes that while there is some existing safety data, efficacy evidence is currently lacking."

Answered by AI

Recent research and studies

NeuroImage: ClinicalJournal

Executive Attention Control and Emotional Responding in Attention-deficit/hyperactivity Disorder — A Functional MRI Study

Hwang, Soonjo, Stuart F. White, Zachary T. Nolan, W. Craig Williams, Stephen Sinclair, and R.J.R. Blair. 2015. “Executive Attention Control and Emotional Responding in Attention-deficit/hyperactivity Disorder — A Functional MRI Study”. Neuroimage: Clinical. Elsevier BV. doi:10.1016/j.nicl.2015.10.005.

PsychoneuroendocrinologyJournal

Oxytocin and Brain Activity in Humans: A Systematic Review and Coordinate-based Meta-analysis of Functional MRI Studies

Grace, Sally A., Susan L. Rossell, Markus Heinrichs, Catarina Kordsachia, and Izelle Labuschagne. 2018. “Oxytocin and Brain Activity in Humans: A Systematic Review and Coordinate-based Meta-analysis of Functional MRI Studies”. Psychoneuroendocrinology. Elsevier BV. doi:10.1016/j.psyneuen.2018.05.031.

American Journal of PsychiatryJournal

Reduced Amygdala Response in Youths with Disruptive Behavior Disorders and Psychopathic Traits: Decreased Emotional Response Versus Increased Top-down Attention to Nonemotional Features

White, Stuart F., Abigail A. Marsh, Katherine A. Fowler, Julia C. Schechter, Christopher Adalio, Kayla Pope, Stephen Sinclair, Daniel S. Pine, and R. James R. Blair. 2012. “Reduced Amygdala Response in Youths with Disruptive Behavior Disorders and Psychopathic Traits: Decreased Emotional Response Versus Increased Top-down Attention to Nonemotional Features”. American Journal of Psychiatry. American Psychiatric Association Publishing. doi:10.1176/appi.ajp.2012.11081270.

Psychological MedicineJournal