Nasal spray versus IV oxytocin for reducing short-term heat pain

Intranasal and Intravenous Oxytocin for Analgesia to Noxious Heat Pain

This trial will test whether oxytocin given as a nasal spray or through an IV can reduce experimentally induced heat pain in healthy adults ages 18–75.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Wake Forest University Health Sciences (other)
• Locations: 1 site (Winston-Salem, North Carolina)
• Trial ID: NCT07053774 on ClinicalTrials.gov

What this trial studies

This is a randomized, triple-masked, crossover Phase 2 trial in healthy adult volunteers comparing intravenous (20 IU) and intranasal (48 IU) oxytocin against matching placebos. Participants first complete a training visit to find the skin temperature that produces a moderate pain rating, then attend two treatment visits in which they receive one active oxytocin route and one placebo route while pain is measured over four hours. Pain ratings during five-minute heat applications are collected at multiple time points and analyzed with mathematical models to compare the time course of analgesia between routes. The study also explores whether age, sex, or body weight affect the pain response to oxytocin.

Who should consider this trial

Good fit: Healthy adults aged 18–75 with BMI under 40, no chronic pain or neuropathy, and no contraindications to oxytocin or intranasal administration are the intended participants.

Not a fit: People with chronic or clinical pain conditions, pregnant or nursing women, those with recent nasal surgery or daily intranasal medications, or anyone allergic to oxytocin likely would not benefit from participating or from direct clinical application of these results.

Why it matters

Potential benefit: If successful, the results could point to a non-opioid approach or preferred route (nasal vs IV) for short-term pain relief and inform future clinical pain trials.

How similar studies have performed: Previous small studies of intranasal oxytocin have reported mixed and inconsistent analgesic effects, so this head-to-head comparison of routes is relatively novel and aims to clarify those findings.

Eligibility criteria

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 reuptake inhibitors (SSRI's), monamine oxidase inhibitors (MAOI), or the recreational drug ecstasy.

Where this trial is running

Winston-Salem, North Carolina

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

Study contacts

• Principal investigator: James C Eisenach, MD — Atrium Health Wake Forest Baptist
• Study coordinator: James C Eisenach, MD

Conditions: Pain, Acute, healthy volunteers, pain control, oxytocin