Primary outcomeMean· Baseline -> Week 4
Change in WOMAC Pain (0-20 Scale)
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Oxytocin | -0.14 | 2.92 |
| Placebo | -0.65 | 3.03 |
Trial · Interventional
CompletedPhase 2/3Results postedRegistry dataUnderstanding Cognition, Oxytocin & Pain in Elders
Short name UCOPE
NCTNCT03878589 (opens ClinicalTrials.gov in a new tab)Other idIRB201801467-NOther idR01AG059809Other idOCR18586
Overview
- Status
- Completed
- Phase
- Phase 2/3
- Enrollment
- 83 participants (actual)
- Sponsor
- University of Florida · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- 6 Aug 2019
- Primary completion
- 19 Dec 2024
- Completion
- 19 Dec 2024
- First posted
- 18 Mar 2019
- Last update posted
- 23 Feb 2026
- Conditions
- Knee Osteoarthritis · Osteoarthritis
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2019202020212022202320242025
- Ph 2/3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Oxytocin (OT)Drug
- Placebo (P)Drug
Arms2
Active comparator
Oxytocin Crossover Placebo Group
During 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.
Active comparator
Placebo Crossover Oxytocin Group
During 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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in WOMAC Pain (0-20 Scale)
Time frame · Baseline -> Week 4
Registry description
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).
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| OxytocinIntranasal oxytocin 24 IU twice daily for 4 weeks | 0 / 66 | 0 / 66 | 43 / 66 |
| PlaceboMatching placebo twice daily for 4 weeks | 0 / 68 | 3 / 68 | 51 / 68 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
0 studies on this page
Indexing hint: Clinical trial · 2025
Understanding Cognition, Oxytocin, and Pain in Elders (UCOPE): protocol for a double-blinded cross-over trial in chronic knee osteoarthritis pain.
Cruz-Almeida et al. 2025Trials
PMID 39920837PMC11806790DOI 10.1186/s13063-024-08715-4PUB-39920837
CC BY
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 45 Years up to 100 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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 Visual Descriptor Scale), and who have elevated levels of plasma Imterleukin-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 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
PepBank is a research reference. Talk to a doctor before you use any peptide.