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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
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
Awards & highlights

UCOPE Trial Summary

This trial will test the efficacy of self-administered intranasal oxytocin (OT) over 4 weeks in older individuals with knee osteoarthritis (OA) relative to placebo (P).

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.Check my eligibility
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.See study design
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.

UCOPE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had knee or back pain for over 6 months, with moderate daily pain and high IL-6 levels.

UCOPE Trial 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
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis) Index
Secondary outcome measures
Change in Frontal Cortex Brain Metabolites

UCOPE 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.

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,341 Previous Clinical Trials
715,297 Total Patients Enrolled
14 Trials studying Osteoarthritis
10,765 Patients Enrolled for Osteoarthritis
National Institute on Aging (NIA)NIH
1,674 Previous Clinical Trials
28,020,535 Total Patients Enrolled
29 Trials studying Osteoarthritis
9,688 Patients Enrolled for Osteoarthritis
Yenisel Cruz-Almeida, PhD, MSPHPrincipal InvestigatorUniversity of Florida

Media Library

Oxytocin (Neuropeptide) Clinical Trial Eligibility Overview. Trial Name: NCT03878589 — Phase 2 & 3
Osteoarthritis Research Study Groups: Placebo Crossover Oxytocin Group, Oxytocin Crossover Placebo Group
Osteoarthritis Clinical Trial 2023: Oxytocin Highlights & Side Effects. Trial Name: NCT03878589 — Phase 2 & 3
Oxytocin (Neuropeptide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03878589 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many test subjects are involved in this experiment?

"Clinicaltrials.gov does have this information available. The trial was posted on 8/6/2019, updated recently on 7/19/2022, and is looking for 370 participants from 2 different locations."

Answered by AI

Does this research project have an age limit for participants?

"According to the eligibility criteria, patients who are 45 to 100 years old may apply for this trial. In contrast, there are 49 studies only involving minors and 719 research projects focused on senior citizens."

Answered by AI

How can I become a participant in this experiment?

"Patients with arthrosis who want to join this trial must be aged 45-100. There are 370 available spots in total."

Answered by AI

What are the usual indications for this medication?

"Oxytocin has many potential medical applications, such as treating hemorrhage, reinforcing labor, and aiding in uterine contractions."

Answered by AI

Are new participants being sought for this trial?

"Yes, this is an ongoing trial that was first posted on 8/6/2019. The listing was updated most recently on 7/19/2022 and they are currently recruiting 370 patients from 2 centres."

Answered by AI

Who else is applying?

What site did they apply to?
UF Health of University of Florida
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Always looking for anything that helps I've lived with constant pain for the last 13 to 14 years.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Understanding Cognition, Oxytocin & Pain in Elders
2019. "Understanding Cognition, Oxytocin & Pain in Elders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03878589.
All > Osteoarthritis > Oxytocin
~0 spots leftby Apr 2024
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