Intranasal Oxytocin for Osteoarthritis

(UCOPE Trial)

No longer recruiting at 1 trial location

Overseen By Natalie Ebner, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of Florida

Must not be taking: Vasoconstrictors, Antidiuretics, Narcotics

Disqualifiers: Heart problems, Rheumatic conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an intranasal spray of oxytocin can reduce pain and improve function in people with knee osteoarthritis. Known as the "love hormone," oxytocin is being tested for its potential to ease pain. Participants will self-administer either oxytocin or a placebo (a substance with no therapeutic effect) over two phases. The trial seeks individuals who have experienced knee osteoarthritis or back pain for at least six months and feel pain on most days.

As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on certain medications like vasoconstrictors or antidiuretics. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that intranasal oxytocin is generally safe for humans. In one study, participants felt calmer and less anxious after using it, and they showed a trend towards lower cortisol levels, a hormone related to stress. While side effects such as a fast or irregular heartbeat can occur with incorrect doses, these are uncommon when the treatment is properly managed. Additionally, oxytocin is already approved for other medical uses, indicating a known safety record. Overall, the safety evidence for oxytocin is reassuring, especially when used with proper guidance. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for osteoarthritis?

Unlike the standard treatments for osteoarthritis, which often include oral pain relievers like NSAIDs or corticosteroid injections, the investigational treatment uses oxytocin administered via an intranasal spray. This unique delivery method allows for potentially faster absorption and more direct action. Researchers are excited about oxytocin because it not only has a different mechanism of action, targeting social and emotional processing pathways, but it also may offer pain relief without the side effects associated with traditional oral medications. This approach could revolutionize how we manage chronic pain in osteoarthritis, offering a more holistic treatment option.

What evidence suggests that intranasal oxytocin might be an effective treatment for osteoarthritis?

Research has shown that a nasal spray with oxytocin might help reduce pain for people with osteoarthritis. Studies have found that oxytocin can increase pain tolerance, meaning individuals might feel less pain. In trials, oxytocin was generally safe and seemed to improve daily activity performance. This trial will compare two groups: one will initially receive oxytocin followed by a placebo, while the other will start with a placebo and then receive oxytocin. This treatment is easy to use at home because it comes as a nasal spray. Overall, early findings suggest that intranasal oxytocin could be a promising option for reducing pain and improving quality of life for those with knee osteoarthritis. ^{1 4 6 7 8}

Who Is on the Research Team?

Yenisel Cruz-Almeida, PhD, MSPH

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Exclusion Criteria

Pregnant individuals will be excluded

Low sodium and high osmolality levels

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants self-administer intranasal spray of either oxytocin or placebo twice a day for 4 weeks

4 weeks

Home administration

Washout

A washout period where no treatment is administered to clear the effects of the first phase

4 weeks

Treatment Phase 2

Participants switch treatments and self-administer intranasal spray of either oxytocin or placebo twice a day for another 4 weeks

4 weeks

Home administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Oxytocin
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Placebo Crossover Oxytocin Group Active Control 2 Interventions

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.

Group II: Oxytocin Crossover Placebo Group Active Control 2 Interventions

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.

Oxytocin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Pitocin for:

• Induction of labor
• Augmentation of labor
• Control of postpartum bleeding

Approved in European Union as Syntocinon for:

• Induction of labor
• Augmentation of labor
• Control of postpartum bleeding

Approved in Canada as Oxytocin for:

• Induction of labor
• Augmentation of labor
• Control of postpartum bleeding

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

In a 26-week study involving 215 patients with osteoarthritis, hylan G-F 20 (HG-F 20) provided significantly better pain relief and functional improvement compared to triamcinolone hexacetonide (TH) at both 12 and 26 weeks.

HG-F 20 demonstrated a longer duration of effect and was better tolerated, with no patients discontinuing treatment due to lack of efficacy, while 15 patients treated with TH did discontinue for this reason.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, single-blind comparison of the efficacy and tolerability of hylan G-F 20 and triamcinolone hexacetonide in patients with osteoarthritis of the knee. Caborn, D., Rush, J., Lanzer, W., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8461687/

Evaluating the efficacy of intranasal oxytocin on pain and ... Given the heterogeneity of extant trials, we propose a methodologically rigorous trial evaluating the efficacy of intranasal oxytocin on pain and function ...

2. trials.arthritis.org trials.arthritis.org/trials/NCT03878589

Understanding Cognition, Oxytocin & Pain in Elders 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10187080/

Evaluating the efficacy of oxytocin for pain management It was reported that oxytocin increased pain tolerance in the majority of studies that met inclusion criteria and that this effect was ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03878589?tab=table

Understanding Cognition, Oxytocin & Pain in Elders This study will test the efficacy and safety of self-administered intranasal oxytocin over 4-weeks in older individuals with knee osteoarthritis. Relative to ...

5. withpower.com withpower.com/trial/phase-2-and-3-osteoarthritis-7-2019-292c0

Intranasal Oxytocin for Osteoarthritis (UCOPE Trial) 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 ...

6. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08715-4

Understanding Cognition, Oxytocin, and Pain in Elders (UCOPE) This study will establish preliminary effectiveness of a novel intervention in middle to older aged adults with knee osteoarthritis pain.

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK507848/

Oxytocin - StatPearls - NCBI Bookshelf - NIH An inappropriate dosage of oxytocin can lead to dangerous tachycardia, arrhythmias, and myocardial ischemia.

8. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT03878589/

Trial | NCT03878589 Relative to placebo, daily administration of intranasal oxytocin diminished self-reported pain, physical and emotional functioning and changes in brain ...