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Hormone Therapy

Oxytocin for Chronic Pain

Q: Does the FDA sanction this medication?

This is a Phase 2 trial, which means that while there is some safety data, none exists yet to support efficacy. Our team gives it a score of 2.

Q: If a person is not yet 50 years old, are they still eligible for this kind of medical research?

This trial is only for individuals aged 18-75. There are already 43 ongoing studies involving minors and 405 trials for seniors.

Q: Are there any vacancies in this clinical research project for participants?

According to the clinicaltrials.gov website, this clinical trial is not looking for participants at the moment. The study was first posted on 1/1/2024 and last updated on 5/6/2022. However, there are 474 other trials that patients can participate in currently.

Q: How many individuals are receiving care as part of this experiment?

Unfortunately, this particular trial is no longer seeking new participants. The study was first posted on January 1st 2024 and the most recent update was May 6th, 2022. However, there are 417 other trials for <a href="https://www.withpower.com/clinical-trials/chronic-pain">chronic pain</a> sufferers that are still admitting patients and 57 studies for this treatment that are actively recruiting patients.

Q: What are the inclusionary criteria for this trial?

Eligible patients for this study must suffer from <a href="https://www.withpower.com/clinical-trials/chronic-pain">chronic pain</a>, be between 18 and 75 years old, and meet other screening criteria. Presently, the clinical trial is looking to enroll 30 individuals.

Q: What are the primary benefits of this medication?

<a href="https://www.withpower.com/clinical-trials/oxytocin">Oxytocin</a> is frequently used to control bleeding, but it has also been shown to help with uterine contractions during labour.

Phase 2

Waitlist Available

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 healthy volunteers, normal blood pressure (systolic 90-140 mmHg; diastolic 50-90 mmHg) resting heart rate 45-100 beats per minute) without medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 minutes post infusion initiation

Awards & highlights

Study Summary

This trial is testing the effects of oxytocin on pain perception.

Who is the study for?

This trial is for healthy men and women aged 18-75, with a BMI under 40, normal blood pressure and heart rate. Women must use effective birth control or abstain from sex. It's not for those with chronic pain, diabetes, neuropathy, daily pain medication users, pregnant or nursing women, or anyone at increased risk as per the investigator.Check my eligibility

What is being tested?

The study tests how oxytocin given through an IV affects perception of pain and vibration on the skin compared to a placebo. Participants will be randomly assigned to receive either oxytocin or placebo without knowing which one they're getting.See study design

What are the potential side effects?

Possible side effects may include reactions at the infusion site due to IV placement and potential discomfort from the heat and vibratory stimuli used in testing perceptions on the skin.

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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My blood pressure and heart rate are within the normal range without medication.

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I am using effective birth control or abstaining from sex.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 minutes post infusion initiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 minutes post infusion initiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes post infusion initiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Heat pain with vibration

Secondary outcome measures

Heat pain without vibration

Trial Design

2Treatment groups

Experimental Treatment

Group I: Placebo, Then OxytocinExperimental Treatment2 Interventions

Placebo administered intravenously for the first half of the study and then will receive intravenous oxytocin for the second half.

Group II: Oxytocin First, then PlaceboExperimental Treatment2 Interventions

Oxytocin administered intravenously for the first half of the study and then will receive intravenous placebo for the second half.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Oxytocin

2016

Completed Phase 4

~2340

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,242 Previous Clinical Trials

1,004,237 Total Patients Enrolled

13 Trials studying Chronic Pain

728 Patients Enrolled for Chronic Pain

James C Eisenach, MDPrincipal InvestigatorWake Forest University Health Sciences

17 Previous Clinical Trials

805 Total Patients Enrolled

4 Trials studying Chronic Pain

94 Patients Enrolled for Chronic Pain

Media Library

Oxytocin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04433741 — Phase 2

Chronic Pain Research Study Groups: Oxytocin First, then Placebo, Placebo, Then Oxytocin

Chronic Pain Clinical Trial 2023: Oxytocin Highlights & Side Effects. Trial Name: NCT04433741 — Phase 2

Oxytocin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04433741 — Phase 2

Frequently Asked Questions

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

Does the FDA sanction this medication?

"This is a Phase 2 trial, which means that while there is some safety data, none exists yet to support efficacy. Our team gives it a score of 2."

Answered by AI

If a person is not yet 50 years old, are they still eligible for this kind of medical research?

"This trial is only for individuals aged 18-75. There are already 43 ongoing studies involving minors and 405 trials for seniors."

Answered by AI

Are there any vacancies in this clinical research project for participants?

"According to the clinicaltrials.gov website, this clinical trial is not looking for participants at the moment. The study was first posted on 1/1/2024 and last updated on 5/6/2022. However, there are 474 other trials that patients can participate in currently."

Answered by AI

How many individuals are receiving care as part of this experiment?

"Unfortunately, this particular trial is no longer seeking new participants. The study was first posted on January 1st 2024 and the most recent update was May 6th, 2022. However, there are 417 other trials for chronic pain sufferers that are still admitting patients and 57 studies for this treatment that are actively recruiting patients."

Answered by AI

What are the inclusionary criteria for this trial?

"Eligible patients for this study must suffer from chronic pain, be between 18 and 75 years old, and meet other screening criteria. Presently, the clinical trial is looking to enroll 30 individuals."

Answered by AI