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Hormone Therapy

Oxytocin for Chronic Pain

Phase 2
Recruiting
Led By James C Eisenach, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For healthy volunteers, normal blood pressure (systolic 90-140 mmHg; diastolic 50-90 mmHg) resting heart rate 45-100 beats per minute) without medication
Male or female > 18 and < 75 years of age, Body Mass Index (BMI) <40
Must not have
Subjects with eye pathology, eye surgery, or taking topical eye medications, or any disease process that would cause motor tremors or excessive eye movements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 180 minutes after study drug administration

Summary

This trial is testing whether oxytocin can help the "rest and digest" system work better.

Who is the study for?
This trial is for adults aged 18-75 with good health, normal blood pressure or controlled hypertension, and a BMI under 40. It's open to both healthy volunteers and those with knee arthritis. Women of childbearing age must use effective birth control. People can't join if they have certain health risks, are pregnant/nursing/recently pregnant, suffer from chronic pain or diabetes, take daily benzodiazepines/pain meds, or have specific eye conditions.
What is being tested?
The study tests the impact of oxytocin (a hormone) given by muscle injection on the 'rest and digest' nervous system activity through pupil response in people with chronic pain/osteoarthritis versus a placebo.
What are the potential side effects?
Potential side effects may include reactions at the injection site, changes in heart rate or blood pressure due to parasympathetic system activation but specifics aren't provided here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood pressure and heart rate are within the normal range without medication.
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I am between 18 and 75 years old with a BMI under 40.
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My blood pressure is normal or controlled, and my heart rate is between 45-100 bpm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have eye conditions or have had eye surgery that affects my vision or causes tremors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline before study drug administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline before study drug administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fluctuation in Pupil Diameter (Hippus) -Post drug administration
Fluctuation in Pupil Diameter (Hippus) -Pre drug administration

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo, Then OxytocinExperimental Treatment2 Interventions
Subjects in this arm will receive Intramuscular placebo injection first then oxytocin injection
Group II: Oxytocin First, then PlaceboExperimental Treatment2 Interventions
Subjects in this arm will receive Intramuscular injection of Oxytocin (Pitocin®) first then placebo injection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxytocin
2016
Completed Phase 4
~2340
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,392 Previous Clinical Trials
2,452,824 Total Patients Enrolled
10 Trials studying Osteoarthritis
924 Patients Enrolled for Osteoarthritis
James C Eisenach, MDPrincipal InvestigatorWake Forest University Health Sciences
17 Previous Clinical Trials
768 Total Patients Enrolled
1 Trials studying Osteoarthritis
80 Patients Enrolled for Osteoarthritis

Media Library

Oxytocin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04427709 — Phase 2
Osteoarthritis Research Study Groups: Placebo, Then Oxytocin, Oxytocin First, then Placebo
Oxytocin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04427709 — Phase 2
Osteoarthritis Clinical Trial 2023: Oxytocin Highlights & Side Effects. Trial Name: NCT04427709 — Phase 2
~1 spots leftby Jan 2025
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