Mode
Text Size
Log in / Sign up
Phase 3 N=83 Randomized Quadruple-blind Treatment

Understanding Cognition, Oxytocin & Pain in Elders

Knee Osteoarthritis · Osteoarthritis

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

Back to search