Intranasal Oxytocin for Osteoarthritis

(UCOPE Trial)

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

119 Participants Needed

Trial Summary

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.

How is intranasal oxytocin different from other osteoarthritis treatments?

Intranasal oxytocin is unique because it is administered through the nose, unlike most osteoarthritis treatments that are injected directly into the joint or taken orally. This method could potentially offer a new way to manage symptoms with fewer side effects. ^{1 2 3 4 5}

What is the purpose of this 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 weeks. Oxytocin may help by changing how the brain processes pain signals.

Research Team

Yenisel Cruz-Almeida, PhD, MSPH

Principal Investigator

University of Florida

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of a topical herbal cream on the pain and stiffness of osteoarthritis: a randomized double-blind, placebo-controlled clinical trial. [2008]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical benefit of intra-articular saline as a comparator in clinical trials of knee osteoarthritis treatments: A systematic review and meta-analysis of randomized trials. [2022]

3. Canada 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. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

The Therapeutic Effect of Intra-articular Normal Saline Injections for Knee Osteoarthritis: A Meta-analysis of Evidence Level 1 Studies. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Intra-articular therapy in osteoarthritis. [2022]