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NCT03878589 | RECRUITING | Knee Osteoarthritis

Understanding Cognition, Oxytocin & Pain in Elders
Sponsor:

University of Florida

Brief 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.

Condition or disease

Knee Osteoarthritis

Osteoarthritis

Intervention/treatment

Oxytocin (OT)

Placebo (P)

Phase

PHASE2

PHASE3

Detailed Description:

Osteoarthritis (OA) represents a significant cause of disability worldwide in individuals aged 65 and older, a rapidly growing segment of our population. The knee is the most commonly affected joint with pain being the primary symptom, negatively impacting physical, cognitive, and emotional functioning. Symptomatic knee OA has been traditionally attributed to peripheral mechanisms, but measures of joint damage only modestly account for the presence or severity of OA-related pain. The neuropeptide oxytocin (OT) has been recognized as a mediator of endogenous analgesia in animal and human studies. However, little is known about the neurobiological mechanisms underlying OT's pain-relieving properties. This study will test the efficacy and safety of self-administered intranasal OT over 4-weeks in older individuals with knee osteoarthritis. Relative to placebo (P), daily administration of intranasal OT diminished self-reported pain, physical and emotional functioning and changes in brain metabolite concentrations. With strong support from the University of Florida and the McKnight Brain Institute, this interdisciplinary project, using a comprehensive multi-methods approach, will be the first to determine the potential benefit of OT as a novel analgesic therapy for knee OA pain in aging.

Study Type : INTERVENTIONAL
Estimated Enrollment : 370 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : Mechanisms Underlying Oxytocin's Analgesia in Older Adults
Actual Study Start Date : 2019-08-06
Estimated Primary Completion Date : 2024-04-30
Estimated Study Completion Date : 2024-08-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 45 Years to 100 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 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
Understanding Cognition, Oxytocin & Pain in Elders

Location Details

NCT03878589

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Locations

RECRUITING

United States, Florida

Department of Community Dentistry and Behavioral Science

Gainesville, Florida, United States, 32603

RECRUITING

United States, Florida

UF Health of University of Florida

Gainesville, Florida, United States, 32610