Intranasal and Intravenous Oxytocin for Analgesia to Noxious Heat Pain

Completed · Phase 2 · Has a placebo group

Conditions studied: Pain, Acute

In brief

The goal of this research study is to find out how well oxytocin works to reduce pain. Oxytocin will be given intravenously (IV) and as a nasal spray. The study team also hopes to find out if the participants age, weight, or sex effects how well the study drug works. Participants will be exposed to a heater on the skin at a training visit and rate how much pain different temperatures cause. On two separate visits, participants will use a nasal spray and get an IV infusion. After the IV and nasal spray, participants will rate the pain of the same skin heating temperature at various time points for 4 hours.

Key facts

Study ID

NCT07053774

Run by

Wake Forest University Health Sciences

People needed

24

Starts

2025-11-05

Expected to finish

2026-06-01

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female > 18 and ≤75 years of age, Body Mass Index (BMI) <40.
• Generally in good health as determined by the Principal Investigator based on prior medical history, and as assessed to be American Society of Anesthesiologists physical status 1, 2, or 3.

You may not qualify if…

• Recent (<3 months) nasal surgery or chronic conditions requiring daily intranasal (IN) medications
• Hypersensitivity to any ingredient in Pitocin® (marketed preparation of oxytocin for parenteral injection)
• Latex allergy
• Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (e.g., active gynecologic disease in which increased tone would be detrimental such as uterine fibroids with ongoing bleeding)
• Women who are pregnant, are currently nursing or lactating, or have been pregnant within 2 years
• Neuropathy, chronic pain (located in any body location that is being treated), diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
• Current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval.
• Past or current history of hyponatremia or at risk for hyponatremia; anyone taking thiazide diuretics, loop diuretics, combination diuretics, lithium, carbamazepine, enalapril, ramipril, celecoxib, temazepam, gliclazide, glimepiride, glibenclamide, glipizide, omeprazole, pantoprazole, desmopressin, serotonin selective reuptake inhibitors (SSRI's), monamine oxidase inhibitors (MAOI), or the recreational drug ecstasy.

Where it is running

• Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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