Mechanisms Underlying Oxytocin's Analgesia in Older Adults

IRB201801467-N

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.

2019-08-06

2024-04-30

2024-08-30

Recruiting

Early phase I

370

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 VDS), and who have elevated levels of plasma IL-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 OA-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., MoCA 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

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2024-04-24