CompletedPhase 2

Intranasal and Intravenous Oxytocin for Analgesia to Noxious Heat Pain

United States24 participantsStarted 2025-11-05

Plain-language summary

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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 reup…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial tested oxytocin given two different ways — through the nose and through an IV — to reduce pain from skin heating, and it's already completed; would it be worth asking whether the results have been published and what they showed about which delivery method, if either, worked better?
2Since this was a Phase 2 trial measuring pain scores during and after a controlled heat pain test, what does that mean for how confident we can be about oxytocin's safety and effectiveness as a real-world pain treatment, compared to standard options I might already have access to?
3The trial used a specific lab-based heat pain model rather than treating an ongoing pain condition — does that kind of experimental setup translate to the type of acute pain I'm actually experiencing, and is oxytocin something my care team would even consider for my situation?
4Given that this study is completed, are there any follow-up Phase 3 trials or other studies building on these findings that might be worth looking into, or is oxytocin for pain relief still too early-stage to be a realistic path for me?
5Both intranasal and IV delivery were studied here — if there were any safety signals or side effects noted with either method, is that something we should factor into any decisions about pain management approaches going forward?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain Scale Score - End of 5-minute Skin Heating

Timeframe: Baseline Up to Hour 4.5

Pain Scale Score - During Skin Heating

Timeframe: Minute 5 During Skin Heating

Trial details

NCT IDNCT07053774

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-01

View on ClinicalTrials.gov More Pain, Acute trials