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Knee OsteoarthritisPhase 2/3UCOPENCT03878589

Understanding Cognition, Oxytocin & Pain in Elders

A Phase 2/3 study testing Oxytocin (OT) in people with Knee Osteoarthritis and Osteoarthritis, run by University of Florida at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 45 to 100 years
Conditions the study is for
Knee Osteoarthritis, Osteoarthritis
What is being tested?
Oxytocin (OT)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
83 participants
Where
2 sitesUnited States
Study dates
6 Aug 2019to 19 Dec 2024
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 Visual Descriptor Scale), and who have elevated levels of plasma Imterleukin-6 (>2.5 pg/ml) will be considered for participation.

Who cannot join

  • 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,
Show all 25Show fewer
  • 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 osteoarthritis-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., Montreal Cognitive Assessment 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 locations and contacts

2 sites in 1 country.

United States2 sites

  • Department of Community Dentistry and Behavioral Science

    Gainesville, Florida, 32603

  • UF Health of University of Florida

    Gainesville, Florida, 32610

Other trials in United States

About this study

Official title: Mechanisms Underlying Oxytocin's Analgesia in Older Adults

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.

Read the detailed description

Osteoarthritis 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 osteoarthritis has been traditionally attributed to peripheral mechanisms, but measures of joint damage only modestly account for the presence or severity of osteoarthritis-related pain. The neuropeptide oxytocin has been recognized as a mediator of endogenous analgesia in animal and human studies. However, little is known about the neurobiological mechanisms underlying oxytocin's pain-relieving properties.

This study will test the efficacy and safety of self-administered intranasal oxytocin over 4-weeks in older individuals with knee osteoarthritis. Relative to placebo, daily administration of intranasal oxytocin 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 oxytocin as a novel analgesic therapy for knee osteoarthritis pain in aging.

Being tested
Oxytocin (OT), Placebo (P)
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oxytocin (OT)Drug

    During the 4 week intervention, participants will self-administer twice daily 24 International Units 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)Drug

    During the 4 week intervention, participants will self-administer twice daily 24 International Units 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.

Study groups in NCT03878589
Study groupRoleWhat they receive
Oxytocin Crossover Placebo GroupActive comparatorDuring Phase 1 of the intervention, participants will self-administer via intranasal spray 24 International Units of oxytocin (OT) twice a day at home, at 8-9 in the morning and again at 5-6 in the afternoon. After a four-week washout period, Phase 2 will consist of a second four weeks of intervention, this time intranasal spray 24 International Units of placebo (P) twice a day will be self-administered.
Receives: Drug: Oxytocin (OT); Drug: Placebo (P)
Placebo Crossover Oxytocin GroupActive comparatorDuring Phase 1 of the intervention, participants will self-administer via intranasal spray 24 International Units of placebo (P) twice a day at home, at 8-9 in the morning and again at 5-6 in the afternoon. After a four-week washout period, Phase 2 will consist of a second four weeks of intervention, this time intranasal spray 24 International Units of oxytocin (OT) twice a day will be self-administered.
Receives: Drug: Oxytocin (OT); Drug: Placebo (P)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in WOMAC Pain (0-20 Scale)

    The WOMAC Pain subscale measures self-reported knee pain severity during daily activities. The subscale consists of 5 items assessing pain during walking, stair climbing, nocturnal pain, pain at rest, and weight-bearing activities. Each item is scored 0-4 (0=none, 4=extreme), yielding a total Pain subscale score of 0-20. Higher scores indicate greater pain severity. Change scores were calculated as post-treatment minus baseline; negative values indicate improvement (reduced pain).

    Measured: Baseline -> Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2019
  2. Study start6 Aug 2019
  3. Primary completion19 Dec 2024
  4. Study completion19 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
This trial will be a double-blinded, randomized crossover group design that will randomize older adults with symptomatic knee Osteoarthritis 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 blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03878589
Sponsor's protocol ID
IRB201801467-N
Other IDs
R01AG059809, OCR18586
Acronym
UCOPE
Status last verified
Dec 2024
First submitted
12 Mar 2019
Last updated
23 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cruz-Almeida Y, Montesino-Goicolea S, Valdes-Hernandez P, Huo Z, Staud R, Ebner NC. Understanding Cognition, Oxytocin, and Pain in Elders (UCOPE): protocol for a double-blinded cross-over trial in chronic knee osteoarthritis pain. Trials. 2025 Feb 7;26(1):44. doi: 10.1186/s13063-024-08715-4.

    PubMed 39920837

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Oxytocin (OT) in people with Knee Osteoarthritis and Osteoarthritis, run by University of Florida at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in WOMAC Pain (0-20 Scale) (time frame: Baseline -> Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03878589, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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