What side effects are associated with this type of intervention?

Common treatments for osteoarthritis include NSAIDs, intra-articular injections, and acetaminophen. NSAIDs can cause gastrointestinal issues such as ulcers and bleeding, cardiovascular risks, and kidney problems. Intra-articular injections, like corticosteroids, may lead to joint infection, pain, and potential cartilage damage with repeated use. Acetaminophen is generally safer but can cause liver damage if taken in high doses. Treatments similar to oxytocin, which is being studied for its analgesic properties, are still under investigation, but potential side effects could include nasal irritation and systemic effects depending on the route of administration.

What prior FDA approvals exist?

The FDA has previously reviewed and partially held trials for drugs targeting nerve growth factor (NGF) for osteoarthritis treatment, such as tanezumab and fasinumab. Tanezumab showed initial promise in reducing pain but was associated with rapidly progressive osteoarthritis and increased joint replacements, leading to its discontinuation. Fasinumab also demonstrated pain reduction but had higher adverse effects, including increased arthropathies. These drugs, while not approved, highlight the challenges in developing treatments targeting endogenous analgesia for osteoarthritis.

What other types of research exist?

Promising alternatives to oxytocin for osteoarthritis patients include: 1) Multimodal analgesia combining non-opioid medications like gabapentin, ketamine, and dexamethasone with paracetamol and NSAIDs. 2) Acupuncture, which has shown effectiveness in managing chronic pain. 3) Intranasal oxytocin, which continues to be explored for its pain-relieving properties. 4) Non-pharmacologic treatments such as physical therapy and lifestyle modifications.

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Neuropeptide

Intranasal Oxytocin for Osteoarthritis (UCOPE Trial)

Phase 2 & 3

Recruiting

Led By Yenisel Cruz-Almeida, PhD, MSPH

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with knee osteoarthritis or back pain of at least six months duration, experiencing 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)

Be older than 18 years old

Must not have

History of hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, or psychogenic polydipsia

Individuals with heart problems (e.g., cardiomyopathy, history of myocardial infarction, arrhythmias, prolonged QT interval)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline; week 1; week 2; week 3; week 4; week 9; week 10; week 11; week 12

Summary

This trial tests a nasal spray containing oxytocin to see if it can reduce pain in older adults with knee osteoarthritis. The spray is used daily for a few weeks. Oxytocin may help by changing how the brain processes pain signals.

Who is the study for?

This trial is for older adults with knee osteoarthritis or back pain lasting over six months, moderate pain levels, and certain blood markers (IL-6 >2.5 pg/ml). It's not for those with heart issues, low sodium/high osmolality, heavy smokers/drinkers, pregnant individuals, metal implants in the body/face/neck, significant nasal problems or recent major surgeries.

What is being tested?

The study tests intranasal Oxytocin (OT) against a placebo over four weeks to see if it helps reduce pain and improve function in elders with osteoarthritis. It also aims to understand how OT affects the brain mechanisms related to pain and aging.

What are the potential side effects?

Possible side effects of Oxytocin may include irritation at the administration site (nose), headache, nausea, changes in heart rate or blood pressure. However individual reactions can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had knee or back pain for over 6 months, with moderate daily pain and high IL-6 levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had low sodium levels or conditions causing excessive thirst or water retention.

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I have a history of heart problems.

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I have used drugs like cocaine through the nose.

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I am taking medication to narrow my blood vessels.

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I do not have any major health issues that could affect my knee OA study participation.

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I have been diagnosed with gastroparesis.

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I have a major nose condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; week 1; week 2; week 3; week 4; week 9; week 10; week 11; week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; week 1; week 2; week 3; week 4; week 9; week 10; week 11; week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; week 1; week 2; week 3; week 4; week 9; week 10; week 11; week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis) Index

Secondary study objectives

Change in Frontal Cortex Brain Metabolites

Trial Design

2Treatment groups

Active Control

Group I: Placebo Crossover Oxytocin GroupActive Control2 Interventions

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.

Group II: Oxytocin Crossover Placebo GroupActive Control2 Interventions

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.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for osteoarthritis (OA) include NSAIDs, which inhibit cyclooxygenase enzymes to reduce inflammation and pain, and intraarticular glucocorticoid injections, which provide localized anti-inflammatory effects for short-term pain relief. Investigational treatments like oxytocin are believed to mediate endogenous analgesia, potentially reducing pain through neurobiological mechanisms. Understanding these mechanisms helps tailor treatments to individual needs, optimizing pain management and improving quality of life for OA patients.