Intranasal Oxytocin for Caregiver Stress

Overseen By Minjoo Kang, MEd

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Nebraska

Must not be taking: Antipsychotics, SSRIs, Corticosteroids

Disqualifiers: Severe liver disease, Seizure disorder, CNS disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 3 weeks

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if intranasal oxytocin, a hormone that can reduce stress, can help caregivers of people with dementia feel less stressed and improve their quality of life. Participants will receive either a low dose, a higher dose of oxytocin, or a placebo (a non-active substance) through a nasal spray for 21 days. The study seeks female caregivers who have cared for someone with dementia for at least five hours a week for six months or more and can travel to the University of Nebraska Medical Center for study visits. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking findings.

Will I have to stop taking my current medications?

If you are currently taking antipsychotic medications, selective serotonin reuptake inhibitors (SSRIs), or corticosteroid creams/pills, you will need to stop taking them to participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that intranasal oxytocin is generally safe. Many studies have tested it without causing serious side effects. Most people do not notice any changes after use. The most common minor issues include slight dizziness, headaches, or nasal irritation, which are usually mild and resolve quickly. Overall, intranasal oxytocin is considered safe and well-tolerated by most individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care for caregiver stress, which often includes counseling and medications like antidepressants, intranasal oxytocin offers a unique approach by using a nasal spray to directly influence brain chemistry. Researchers are excited about this treatment because oxytocin is a hormone known for its role in social bonding and stress reduction, which could provide a more targeted way to alleviate caregiver stress. Moreover, the delivery method—through the nose—allows the hormone to reach the brain quickly, potentially offering faster relief compared to traditional oral medications. The trial explores two dosages, 12 IU and 24 IU, to determine the most effective concentration for reducing stress, making it a promising innovation in the field.

What evidence suggests that intranasal oxytocin might be an effective treatment for caregiver stress?

This trial will compare the effects of different doses of intranasal oxytocin with a placebo in reducing caregiver stress. Research has shown that a nasal spray containing oxytocin can reduce stress and improve quality of life. Studies have found it effective in lowering stress for individuals with anxiety, depression, and PTSD. One study discovered that oxytocin enhanced the effectiveness of social support in reducing stress. Another review highlighted its benefits for those with anxiety and depression. While specific data for caregivers of Alzheimer's patients is still being gathered, these findings suggest oxytocin might help manage stress and improve life for caregivers. ^{2 5 6 7 8}

Who Is on the Research Team?

Soonjo Hwang, MD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Right-handed

I am a woman aged 50 or older.

Capacity to read and write in English

Exclusion Criteria

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 MRI scanning

Mini-mental status exam score of 25 or lower which suggests possible cognitive issues

History of or current drug or alcohol abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive intranasal oxytocin or placebo daily for 21 days

3 weeks

Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Intranasal Oxytocin

Trial Overview 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.

How Is the Trial Designed?

Group I: Oxytocin Intranasal Spray 12 International Units Active Control 2 Interventions

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.

Group II: Oxytocin Intranasal Spray 24 International Units Active Control 2 Interventions

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.

Group III: Intranasal Spray Placebo Placebo Group 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Published Research Related to This Trial

Intranasal administration of oxytocin (OT) effectively increases its concentration in the cerebrospinal fluid (CSF) and plasma, suggesting it can reach central nervous system targets.

Both delivery methods (intranasal spray and nebulizer) were effective in elevating CSF OT levels, with the nasal spray showing greater increases in plasma OT concentration compared to the nebulizer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CSF and blood oxytocin concentration changes following intranasal delivery in macaque. Dal Monte, O., Noble, PL., Turchi, J., et al.[2021]

Intranasal oxytocin has been studied in 261 children across various trials, primarily focusing on autism spectrum disorder (ASD) and Prader-Willi syndrome (PWS), but results for efficacy in ASD are mixed and there is currently no evidence supporting its benefit for PWS.

Adverse events related to intranasal oxytocin are mostly mild, with few moderate or severe cases reported, indicating a generally safe profile; however, monitoring and reporting of these events are inconsistent, highlighting the need for improved adherence and safety protocols in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of the Safety, Efficacy and Mechanisms of Delivery of Nasal Oxytocin in Children: Therapeutic Potential for Autism and Prader-Willi Syndrome, and Recommendations for Future Research. DeMayo, MM., Song, YJC., Hickie, IB., et al.[2018]

This study is the first double-blind randomized controlled trial examining the side effects of intranasal oxytocin in 100 elementary school-aged children, showing that it is likely safe with no significant side effects reported.

Most side effects were mild and resolved within 24 hours, indicating that intranasal oxytocin is well tolerated in children aged 8-12 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No side-effects of single intranasal oxytocin administration in middle childhood. Verhees, MWFT., Houben, J., Ceulemans, E., et al.[2019]

Oxytocin (OXT) can be effectively delivered to the brain through nasal administration, achieving higher brain concentrations compared to intravenous delivery, despite lower plasma levels.

The study found that the nasal bioavailability of OXT is approximately 2%, and its therapeutic effects, such as stress relief, were observed only after intranasal application, highlighting the potential of this route for treating conditions like autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivery of Oxytocin to the Brain for the Treatment of Autism Spectrum Disorder by Nasal Application. Tanaka, A., Furubayashi, T., Arai, M., et al.[2019]

A study involving 95 generally healthy older men found that chronic intranasal oxytocin (OT) administration for 4 weeks was safe and well-tolerated, with no significant adverse effects on cardiovascular or metabolic health.

The incidence and severity of adverse events were low and similar between the OT and placebo groups, suggesting that OT does not increase the risk of side effects in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of chronic intranasal oxytocin in older men: results from a randomized controlled trial. Rung, JM., Horta, M., Tammi, EM., et al.[2023]

A systematic review of five randomized controlled trials involving 223 participants found that long-term use of intranasal oxytocin in treating autism spectrum disorder (ASD) is generally well tolerated, with common side effects like nasal discomfort and tiredness not significantly linked to the treatment.

While some severe adverse events were reported, such as aggression and seizures, the overall safety profile suggests that intranasal oxytocin is safe for use in the ASD population, warranting further research to assess its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of reported adverse events of long-term intranasal oxytocin treatment for autism spectrum disorder. Cai, Q., Feng, L., Yap, KZ.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6361048/

The Role of Intranasal Oxytocin in Anxiety and Depressive ... The present review systematically summarized all RCTs evaluating the effects of IN-OT in people affected by anxiety or depressive disorders.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06364228

Study Details | NCT06364228 | Intranasal Oxytocin ... Intranasal OXT interventions have been shown to successfully reduce stress and increase quality of life in other populations, including patients with borderline ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S016503272032752X

Intranasal oxytocin and the stress-buffering effects of social ... This study examined whether intranasal oxytocin enhances the stress-buffering effects of social support during experimentally induced pain.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5323507/

The Effects of Intranasal Oxytocin Administration on ... The current study explores the role of OT in the provision of sensitive caregiving by mothers diagnosed with PND, using a within-subject, ...

5. nature.com nature.com/articles/s41380-022-01845-8

The effect of oxytocin nasal spray on social interaction in ... We investigated the efficacy, tolerability, and safety of intranasal oxytocin in young children with autism using a double-blind, randomized, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11804147/

Oxytocin in old age psychiatry: A systematic review of the ... The primary objective of this study was to systematically review the safety of using intranasal oxytocin in the older population and to compile ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21429671/

A review of safety, side-effects and subjective reactions to ... The evidence shows that intranasal oxytocin: (1) produces no detectable subjective changes in recipients, (2) produces no reliable side-effects, ...

8. researchgate.net researchgate.net/publication/50831059_A_review_of_safety_side-effects_and_subjective_reactions_to_intranasal_oxytocin_in_human_research

A review of safety, side-effects and subjective reactions to ... It has an excellent safety profile and low misuse potential, with the most common adverse effects being light dizziness, headache, or nasal irritation.