Understanding Cognition, Oxytocin & Pain in Elders

Osteoarthritis Clinical Trial

— UCOPE  

Official title:

Mechanisms Underlying Oxytocin's Analgesia in Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03878589
• Other study ID #: IRB201801467-N
• Secondary ID: R01AG059809OCR18
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: August 6, 2019
• Est. completion date: August 30, 2024

Study information

• Verified date: June 2023
• Source: University of Florida
• Contact: Yenisel Cruz-Almeida, PhD, MSPH
• Phone: 352-294-5845
• Email: cryeni[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 370
• Est. completion date: August 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis

Intervention

Drug:
• Oxytocin (OT)
During the 4 week intervention, participants will self-administer twice daily 24 IUs intranasal oxytocin (OT) and will be contacted once a week for assessment of adverse effects and for download of the smartwatch data. During the last week of the intervention period, three assessment sessions will follow that will be identical to the baseline sessions.
• Placebo (P)
During the 4 week intervention, participants will self-administer twice daily 24 IUs intranasal placebo (P) and will be contacted once a week for assessment of adverse effects and for download of the smartwatch data. During the last week of the intervention period, three assessment sessions will follow that will be identical to the baseline sessions.

Locations

Country	Name	City	State
United States	Department of Community Dentistry and Behavioral Science	Gainesville	Florida
United States	UF Health of University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis) Index	Self-reported pain and function. Summary scores of the WOMAC range from 0 (No pain or disability) to 96 (Extreme pain or disability).	Baseline; Week 1; Week 2; Week 3; Week 4; Week 9; Week 10; Week 11; Week 12
Secondary	Change in Frontal Cortex Brain Metabolites	Track levels of the frontal cortex brain chemicals (tCr, MI, Cho) through use of magnetic resonance spectroscopy (MRS).	Baseline; Week 1; Week 2; Week 3; Week 4; Week 9; Week 10; Week 11; Week 12