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Hormone Therapy

IV Oxytocin for 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

Male or female > 18 and < 75 years of age, Body Mass Index (BMI) <40

For knee arthritis subjects, normal blood pressure or, for those with hypertension, pressure controlled with anti-hypertensives and with a resting heart rate 45-100 beats per minute

Must not have

Subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis

Subjects with current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 180 minutes after baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial investigates how oxytocin affects pain when administered through IV and how long the effects last.

Who is the study for?

This trial is for adults aged 18-75 with a BMI under 40, in good health or controlled hypertension, and not on daily pain medications. Women of childbearing age must use effective birth control. It excludes those with allergies to Pitocin®, chronic conditions that increase risk, pregnant/nursing women, individuals with certain heart issues or neuropathy, and those at risk for hyponatremia.

What is being tested?

The study tests how oxytocin given through an IV affects the perception of heat pain on the skin. Participants will rate their pain during intervals before, during, and after receiving oxytocin to help create models predicting its analgesic effects.

What are the potential side effects?

While specific side effects are not listed for this trial's intervention (oxytocin), common reactions may include nausea, headache, changes in blood pressure or heart rate; allergic reactions are possible but considered exclusionary.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 75 years old with a BMI under 40.

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I have knee arthritis with normal blood pressure or controlled hypertension and my resting 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 neuropathy, chronic pain, diabetes, or take daily pain or anxiety medication.

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I have a history of irregular heartbeats or prolonged QT interval.

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I felt little to no pain when my lower calf was heated up to 47°C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 180 minutes after baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~180 minutes after baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 minutes after baseline for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Pain during sustained heat

Side effects data

From 2023 Phase 4 trial • 108 Patients • NCT04028765

Blood transfusion

100%

80%

60%

40%

20%

Study treatment Arm

Oral Misoprostol-Mothers

Oxytocin-Mothers

Oral Misoprostol-Fetus/Neonate

Oxytocin-Fetus/Neonate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intravenous OxytocinExperimental Treatment1 Intervention

Two 30 minute infusion of oxytocin, 17 micrograms with will be administered. The second infusion will be given 30 minutes after the completion of the first infusion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oxytocin

2016

Completed Phase 4

~2340

0 / 5Eligibility criteria met