NCT03878589

Understanding Cognition, Oxytocin & Pain in Elders

Mechanisms Underlying Oxytocin's Analgesia in Older Adults

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 45 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Osteoarthritis (OA) represents a significant cause of disability worldwide and the knee is the most commonly affected joint. Oxytocin (OT) is a mediator of endogenous analgesia in animal and human studies. This proposal will test the efficacy and safety of self-administered intranasal OT over 4-weeks in older individuals relative to placebo (P) evaluating its effects on pain and function in aging and testing potential underlying neurobiological mechanisms.

Detailed description

Osteoarthritis represents a significant cause of disability worldwide in individuals aged 65 and older, a rapidly growing segment of our population. The knee is the most commonly affected joint with pain being the primary symptom, negatively impacting physical, cognitive, and emotional functioning. Symptomatic knee osteoarthritis has been traditionally attributed to peripheral mechanisms, but measures of joint damage only modestly account for the presence or severity of osteoarthritis-related pain. The neuropeptide oxytocin has been recognized as a mediator of endogenous analgesia in animal and human studies. However, little is known about the neurobiological mechanisms underlying oxytocin's pain-relieving properties. This study will test the efficacy and safety of self-administered intranasal oxytocin over 4-weeks in older individuals with knee osteoarthritis. Relative to placebo, daily administration of intranasal oxytocin diminished self-reported pain, physical and emotional functioning and changes in brain metabolite concentrations. With strong support from the University of Florida and the McKnight Brain Institute, this interdisciplinary project, using a comprehensive multi-methods approach, will be the first to determine the potential benefit of oxytocin as a novel analgesic therapy for knee osteoarthritis pain in aging.

Conditions

• Knee Osteoarthritis
• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Oxytocin (OT)	During the 4 week intervention, participants will self-administer twice daily 24 International Units intranasal oxytocin (OT) and will be contacted once a week for assessment of adverse effects and for download of the smartwatch data. During the last week of the intervention period, three assessment sessions will follow that will be identical to the baseline sessions.
DRUG	Placebo (P)	During the 4 week intervention, participants will self-administer twice daily 24 International Units intranasal placebo (P) and will be contacted once a week for assessment of adverse effects and for download of the smartwatch data. During the last week of the intervention period, three assessment sessions will follow that will be identical to the baseline sessions.

Timeline

• Start date: 2019-08-06
• Primary completion: 2024-12-19
• Completion: 2024-12-19
• First posted: 2019-03-18
• Last updated: 2026-02-23
• Results posted: 2026-02-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study