Oxytocin for Pain Relief

Recruiting in Palo Alto (17 mi)

Overseen byJames C Eisenach, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Wake Forest University Health Sciences

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this study is to validate the pharmacodynamic model for pain relief from oxytocin at a peripheral site by intravenous infusion targeted at different levels of the drug. In this study healthy volunteers and people with knee arthritis so severe that they may need joint replacement are recruited for a one day study. Each study participant will have an intravenous(IV) catheter placed. After placement of the IV catheter oxytocin will be given by IV infusion in varying amounts. The study team will perform some tests to evaluate how oxytocin changes perceptions on the skin. The study team will study a painful perception by placing a probe on the skin and heating it to 113 degrees Fahrenheit for 5 minutes. Each study participant will score any pain that is experienced on a 0 to 10 scale.

Eligibility Criteria

This trial is for men and women aged 18-75 with a BMI under 40. Women of childbearing age must use effective birth control. Participants should be in good health or, if they have knee arthritis, have controlled blood pressure. People can't join if they're pregnant, nursing, recently pregnant, have certain chronic conditions like neuropathy or diabetes, take daily pain medications, or are allergic to Pitocin ingredients.

Inclusion Criteria

People who are male or female, 18 years old or older, and have a BMI of less than 40 are eligible for the study.

Male or female > 18 and < 75 years of age

Female subjects of child-bearing potential and those < 1 year post-menopausal, must be practicing highly effective methods of birth control such as hormonal methods (e.g., combined oral, implantable, injectable, or transdermal contraceptives), double barrier methods (e.g., condoms, sponge, diaphragm, or vaginal ring plus spermicidal jellies or cream), or total abstinence from heterosexual intercourse for a minimum of 1 full cycle before study drug administration

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Exclusion Criteria

Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data

Women who are pregnant (positive result for serum pregnancy test at screening visit), women who are currently nursing or lactating, women that have been pregnant within 2 years

You have conditions like nerve damage, long-lasting pain, diabetes, or regularly take medications for pain or anxiety.

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Treatment Details

Interventions

Oxytocin (Hormone Therapy)

Trial OverviewThe study tests how oxytocin given by IV affects pain relief at the site of injection in healthy volunteers and those with severe knee arthritis. The drug's effects on skin perception will be measured using a heated probe while participants rate their pain on a scale from 0 to 10.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: OxytocinExperimental Treatment1 Intervention

Oxytocin will be administered at increasing and decreasing rates

Oxytocin is already approved in United States, European Union, Canada, Australia for the following indications:

🇺🇸 Approved in United States as Pitocin for: