Phase 3
N=83
Understanding Cognition, Oxytocin & Pain in Elders
Knee Osteoarthritis · Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT03878589 ↗Enrolled (actual)
83
Serious AEs
2.2%
Results posted
Feb 2026
Primary outcome: Primary: Change in WOMAC Pain (0-20 Scale) — -0.14; -0.65 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Oxytocin (OT) (Drug); Placebo (P) (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in WOMAC Pain (0-20 Scale) |
-0.14; -0.65 | — |
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.
Eligibility Criteria
Inclusion Criteria
- knee osteoarthritis/or back pain of at least six months duration, experience pain on more days than not, with moderate pain at baseline (i.e., > 3/6 in the Visual Descriptor Scale), and who have elevated levels of plasma Imterleukin-6 (>2.5 pg/ml) will be considered for participation.
Exclusion Criteria
- Hypersensitivity to OT or vasopressin,
- history of hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, or psychogenic polydipsia,
- on vasoconstrictors such as desmopressin, pseudoephedrine, or antidiuretic medication,
- low sodium and high osmolality levels,
- excessive smoking,
- excessive drinking,
- muscle pain as a result of systemic disease,
- significant nasal pathology,
- previous or concurrent use of narcotics delivered intranasally (e.g., cocaine),
- gastroparesis.
- individuals with heart problems (e.g., cardiomyopathy, history of myocardial infarction, arrhythmias, prolonged QT interval)
- Participants will also be excluded if they have concurrent medical or arthritic conditions that could confound symptomatic knee osteoarthritis-related outcomes or coexisting disease that could preclude successful completion of the protocol including:
- systemic rheumatic condition (e.g. rheumatoid arthritis, systemic lupus erythematosus, fibromyalgia);
- a history of clinically significant surgery to the index knee;
- uncontrolled hypertension (>150/95);
- poorly controlled diabetes (HbA1c>7%);
- neurological disease (e.g., Parkinson's, Multiple Sclerosis);
- cardiovascular or peripheral arterial disease;
- serious psychiatric disorder requiring hospitalization within the past twelve months or characterized by active suicidal ideation;
- diminished cognitive function that would interfere with completion of study procedures (i.e., Montreal Cognitive Assessment score < 25)]; and
- large pieces of metal in the body or metal in the face or neck,
- claustrophobia,
- major medical surgery in the past two months,
- history of brain surgery or any serious brain condition like aneurysm, stroke, or seizures].
- pregnant individuals will be excluded
Data sourced from ClinicalTrials.gov (NCT03878589). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.