Understanding Cognition, Oxytocin & Pain in Elders
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Knee Osteoarthritis, Osteoarthritis
In brief
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.
Key facts
- Study ID
- NCT03878589
- Run by
- University of Florida
- People needed
- 83
- Starts
- 2019-08-06
- Expected to finish
- 2024-12-19
- Last updated by the study team
- 2026-02-23
Who can join
Age: 45 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Department of Community Dentistry and Behavioral Science — Gainesville, Florida, United States
- UF Health of University of Florida — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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