Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT06364228
Phase
PHASE2
Status
Recruiting
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Conditions

  • Stress

Eligibility Criteria

Sex
FEMALE
Age
50 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 20, 2026
Status verified
Jul 2025
Primary completion
May 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical Center, Department of PsychiatryOmahaNebraska61898-5581
Chase Brice, B.S.
[email protected]
402-552-6239
Soonjo Hwang, MD (PRINCIPAL_INVESTIGATOR)
Janelle N Beadle, PhD (SUB_INVESTIGATOR)

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By research site
University of Nebraska Medical Center, Department of Psychiatry· Omaha, NE

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