Intranasal Oxytocin for Caregiver Stress

Recruiting in Palo Alto (17 mi)

Overseen bySoonjo Hwang, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Nebraska

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The overall aim of this study is to determine the efficacy and safety of intranasal oxytocin (OXT) to improve the quality of life and reduce chronic stress levels in the caregivers to the persons with dementia. Randomized, double-blind, placebo-controlled clinical trial of intranasal oxytocin (12 or 24 IU) will be conducted by daily administration (once a day) for 21 days (3 weeks).

Research Team

Soonjo Hwang, MD

Principal Investigator

University of Nebraska

Eligibility Criteria

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

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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

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Treatment Details

Interventions

Intranasal Oxytocin (Hormone Therapy)

Trial OverviewThe 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.

Participant Groups

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. Functional magnetic resonance imaging (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. Functional magnetic resonance imaging (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. Functional magnetic resonance imaging (fMRI) scan pre- and post-administration.