Understanding Cognition, Oxytocin & Pain in Elders

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 55 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03878589
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Florida
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Yenisel Cruz-Almeida, PhD, MSPH
Principal Investigator Affiliation University of Florida
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherNIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Knee Osteoarthritis, Osteoarthritis
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Oxytocin Crossover Placebo Group

During Phase 1 of the intervention, participants will self-administer via intranasal spray 24 IUs of oxytocin (OT) twice a day at home, at 8-9AM and again at 5-6PM. After a four-week washout period, Phase 2 will consist of a second four weeks of intervention, this time intranasal spray 24 IUs of placebo (P) twice a day will be self-administered.

Active Comparator: Placebo Crossover Oxytocin Group

During Phase 1 of the intervention, participants will self-administer via intranasal spray 24 IUs of placebo (P) twice a day at home, at 8-9AM and again at 5-6PM. After a four-week washout period, Phase 2 will consist of a second four weeks of intervention, this time intranasal spray 24 IUs of oxytocin (OT) twice a day will be self-administered.

Interventions

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.

Drug: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Gainesville, Florida

Status

Recruiting

Address

Department of Community Dentistry and Behavioral Science

Gainesville, Florida, 32603

UF Health of University of Florida, Gainesville, Florida

Status

Recruiting

Address

UF Health of University of Florida

Gainesville, Florida, 32610