Understanding Cognition, Oxytocin & Pain in Elders

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: National Institute on Aging (NIA)
• Treatments: Oxytocin

Criteria

Inclusion Criteria:

• knee osteoarthritis

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