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Understanding Cognition, Oxytocin & Pain in Elders (UCOPE)

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ClinicalTrials.gov Identifier: NCT03878589
Recruitment Status : Not yet recruiting
First Posted : March 18, 2019
Last Update Posted : July 1, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
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 Intervention/treatment Phase
Knee Osteoarthritis Osteoarthritis Drug: Oxytocin (OT) Drug: Placebo (P) Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This trial will be a double-blinded, randomized crossover group design that will randomize older adults with symptomatic knee OA pain to four weeks of intranasal self-administration of either oxytocin (OT) or placebo (P) (48 IUs daily) followed by a four-week washout period and a second four weeks of intervention (either OT or P).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mechanisms Underlying Oxytocin's Analgesia in Older Adults
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Oxytocin

Arm Intervention/treatment
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.
Drug: Oxytocin (OT)
During the 4 week intervention, participants will self-administer twice daily 24 IUs intranasal oxytocin (OT) and will come into the lab 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 come into the lab 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.

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.
Drug: Oxytocin (OT)
During the 4 week intervention, participants will self-administer twice daily 24 IUs intranasal oxytocin (OT) and will come into the lab 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 come into the lab 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.




Primary Outcome Measures :
  1. Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis) Index [ Time Frame: Baseline; Week 1; Week 2; Week 3; Week 4; Week 9; Week 10; Week 11; Week 12 ]
    Self-reported pain and function. Summary scores of the WOMAC range from 0 (No pain or disability) to 96 (Extreme pain or disability).


Secondary Outcome Measures :
  1. Change in Frontal Cortex Brain Metabolites [ Time Frame: Baseline; Week 1; Week 2; Week 3; Week 4; Week 9; Week 10; Week 11; Week 12 ]
    Track levels of the frontal cortex brain chemicals (tCr, MI, Cho) through use of magnetic resonance spectroscopy (MRS).



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 or 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.
  • 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].

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03878589


Contacts
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Contact: Yenisel Cruz-Almeida, PhD, MSPH 352-294-5845 cryeni@ufl.edu
Contact: Natalie Ebner, PhD natalie.ebner@ufl.edu

Locations
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United States, Florida
Department of Community Dentistry and Behavioral Science Not yet recruiting
Gainesville, Florida, United States, 32603
UF Health of University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Yenisel Cruz-Almeida, PhD, MSPH University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03878589     History of Changes
Other Study ID Numbers: IRB201801467-N
R01AG059809 ( U.S. NIH Grant/Contract )
OCR18586 ( Other Identifier: UF OnCore )
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs