Intranasal oxytocin to reduce stress in family caregivers of people with dementia
Official title: Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia
Run by University of Nebraska · NCT06364228 · Data updated 2026-11-12
This trial will test whether giving nasal oxytocin to female family caregivers of people with dementia can lower their stress and improve well-being.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 50 Years and up |
| Sex | Women only |
| Enrollment | 32 (estimated) |
| Sponsor | University of Nebraska Academic / other |
| Locations | 1 site (Omaha, Nebraska) |
| Status | Recruiting |
| Started | December 20, 2026 |
| Main results expected | November 2027 |
| Study ends | March 2028 |
| Registry record updated | November 2, 2026 |
| Trial ID | NCT06364228 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 50 or older who are unpaid family caregivers to an older adult with dementia for at least five hours per week for six consecutive months, are right-handed, can travel to the University of Nebraska Medical Center for visits including fMRI, and can read and write English.
✕Probably not a fit
Those unlikely to benefit include male caregivers, people with medical contraindications to oxytocin or MRI (for example serious CNS disease, seizure disorder, metal implants), pregnant women, or caregivers who do not meet the minimum caregiving time or duration requirements.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 randomized, placebo-controlled trial enrolls female unpaid family caregivers aged 50 and older who provide at least five hours of care per week for six months to a person with dementia. Participants are randomly assigned to receive 12 IU intranasal oxytocin, 24 IU intranasal oxytocin, or placebo, and undergo functional MRI and other study procedures at baseline and during the intervention. The study measures changes in self-reported stress, quality of life, and neural activity patterns linked to stress and social processing. The goal is to determine whether short-term oxytocin administration produces measurable psychological and brain-function benefits for caregivers.
Why it matters
Potential benefit: If successful, the intervention could reduce chronic stress and improve mood and quality of life for female caregivers, potentially improving both caregiver health and the care they provide.
How similar studies have gone: Intranasal oxytocin has shown stress- and social-function benefits in other disorders such as PTSD, anxiety, and mood disorders, but it has not been comprehensively tested in family caregivers of people with dementia.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University of Nebraska Medical Center, Department of Psychiatry
Omaha, Nebraska, United States Recruiting
Study contacts
- Principal investigator: Soonjo Hwang, MD — University of Nebraska
- Study coordinator: Soonjo Hwang, MD
- Email: soonjo.hwang@unmc.edu
- Phone: 402-552-6351
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.