Recruiting
Phase 2

Oxytocin

Sponsor:

University of Nebraska

Code:

NCT06364228

Conditions

Stress

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Accepted

Interventions

Placebo

Oxytocin Intranasal Spray 12 International Unit (12IU)

Oxytocin Intranasal Spray 24 International Unit (24IU)

Functional MRI

Study Details

Brief summary:

More than 15 million family caregivers provide support for individuals with Alzheimer's disease (AD) or related dementias. This number is expected to grow with the increasing population of persons with dementia (PWD). Stress in caregivers to older adults with chronic diseases is already a significant public health issue because it is associated with multiple negative physical and mental health outcomes for the caregiver (e.g., depression, cardiovascular disease) and can negatively impact the health of the PWD as well. Importantly, stress levels are even higher in female than male caregivers and in caregivers to PWD than other chronic conditions that affect older adults.

There are numerous interventions to improve well-being in caregivers to PWD, but only two have been shown to moderately improve caregiver depression and quality of life in the PWD. However, both of the interventions are time and energy intensive. One promising candidate to reduce stress and improve quality of life is the endogenous neuropeptide oxytocin (OXT). Intranasal OXT interventions have been shown to successfully reduce stress and increase quality of life in other populations, including patients with borderline personality disorder, Post-traumatic Stress Disorder (PTSD), Anxiety Disorder, and Depressive Disorder. This study will assess the efficacy and safety of intranasal oxytocin (OXT) to improve the quality of life and reduce chronic stress levels in the caregivers to PWD. Participants will be randomly enrolled to one of three groups: 12 IU intranasal oxytocin, 24 IU intranasal oxytocin or placebo. The study drug will be administered daily for 21 days.

Conditions

Stress

Study ID

NCT06364228

Start date

Jun 20, 2026

Status verified date

Jul, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Females 50 years of age or older
  • Currently an unpaid family caregiver to an older adult (50 years and older) with dementia for at least five hours a week for at least six months
  • Normal or corrected to normal vision and hearing
  • Mobility to travel to University of Nebraska Medical Center (UNMC) for study procedures including brain imaging
  • Right-handed
  • Capacity to read and write English

Exclusion Criteria:

  • Major medical illness that contraindicates oxytocin (OXT) administration (e.g., severe liver disease, seizure disorder, metabolic disorder)
  • History of allergic reaction to oxytocin (OXT) and its nasal spray product
  • History of central nervous system (CNS) disease, including history of seizure, epilepsy, CNS tumor, CNS hemorrhage, or serious CNS infection including meningitis or encephalitis
  • Currently pregnant or planning to become pregnant during the course of the study
  • Metal in the body (i.e., hearing aid, cardiac pacemaker, bone plates, braces, non-removable piercing/implants, etc.), claustrophobia, or any other condition that would preclude magnetic resonance imaging (MRI) scanning
  • Mini-mental status exam score of 25 or lower which suggests possible cognitive issues
  • History of or current neurological disease (e.g., stroke, traumatic brain injury, brain tumor, dementia)
  • History of or current severe psychiatric disease (e.g., schizophrenia, bipolar disorder, autism, severe post-traumatic stress disorder)
  • History of, or current drug or alcohol abuse
  • Currently breastfeeding
  • Current coronavirus disease-19 (COVID-19) illness
  • Left-handed due to brain structural difference between right and left-handed individuals
  • Currently taking antipsychotic medications, selective serotonin reuptake inhibitors (SSRIs) or corticosteroid creams/pills

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Intranasal Spray Placebo

Nasal spray of placebo liquid solution is administered as 2 puffs of daily dose (every morning) for 3 weeks. Functional magnetic resonance imaging (fMRI) scan will be done pre- and post-administration.

active comparator: Oxytocin Intranasal Spray 12 International Units

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

active comparator: Oxytocin Intranasal Spray 24 International Units

Nasal spray of Oxytocin 24 International Units (24IU) liquid solution as 2 puffs of daily dose (every morning) for 3 weeks. Functional magnetic resonance imaging (fMRI) scan pre- and post-administration.

Interventions

Placebo

Placebo intranasal spray liquid with no oxytocin will be delivered in 2 puffs to each nostril daily for 21 days. The first single dose will be administered at the clinic (Visit 1).

Oxytocin Intranasal Spray 12 International Unit (12IU)

Participants weighing less than 40 kg (88 pounds) will receive 12 IU of oxytocin delivered as 1 puff (6 IU) to each nostril daily for 21 days. The first single dose will be administered at the clinic (Visit 1).

Oxytocin Intranasal Spray 24 International Unit (24IU)

Participants weighing more than 40 kg (880 pounds) will receive 24 IU of oxytocin delivered as 2 puffs (12 IU) to each nostril daily for 21 days. The first single dose will be administered at the clinic (Visit 1).

Functional MRI

Functional MRI (fMRI) scan with affective Stroop and Empathy and Theory of Mind task (EmpaTom task will administered pre- and post-administration of oxytocin.

Primary outcome measure

  • Chronic Stress Level in the Past Thirty Days [ Time Frame: Baseline (Visit 1) and Post-intervention (Visit 2) ]

Central Contacts and Locations

Central contacts

Soonjo Hwang, MD

402-552-6351soonjo.hwang@unmc.edu

Minjoo Kang, MEd

402-552-6239mkang@unmc.edu

Locations

University of Nebraska Medical Center, Department of Psychiatry

Recruiting

Omaha, Nebraska, United States, 61898-5581

Contacts

Chase Brice, B.S.

402-552-6239cbrice@unmc.edu

Principal Investigator:

Soonjo Hwang, MD

More Information

Sponsor

University of Nebraska

Last update posted

May 5, 2026

Last verified

Jul, 2025

Keywords

  • Oxytocin
  • Stress level
  • Caregivers
  • Dementia
  • fMRI
  • Neuroimaging
  • Quality of Life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Nebraska on 2026-05-05.