Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT07053774

Intranasal and Intravenous Oxytocin for Analgesia to Noxious Heat Pain

Led by Wake Forest University Health Sciences · Updated on 2026-03-30

24

Participants Needed

1

Research Sites

32 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Intranasal and Intravenous Oxytocin for Analgesia to Noxious Heat Pain

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged over 18 and up to 75 years with Body Mass Index (BMI) less than 40
  • Generally in good health as determined by the Principal Investigator
  • Assessed as American Society of Anesthesiologists physical status 1, 2, or 3
Not Eligible

You will not qualify if you...

  • Recent (less than 3 months) nasal surgery or chronic conditions requiring daily intranasal medications
  • Allergy to any ingredient in Pitocin (oxytocin injection)
  • Latex allergy
  • Any medical or surgical condition that increases risk as judged by the Principal Investigator, including active gynecologic disease with bleeding
  • Women who are pregnant, nursing, lactating, or have been pregnant within 2 years
  • Neuropathy, chronic pain being treated, diabetes mellitus, or daily use of benzodiazepines or pain medications
  • Current or past ventricular tachycardia, atrial fibrillation, or prolonged QT interval
  • Past or current hyponatremia or risk for hyponatremia, or taking certain listed medications including diuretics, lithium, carbamazepine, enalapril, ramipril, celecoxib, temazepam, sulfonylureas, proton pump inhibitors, desmopressin, SSRIs, MAOIs, or recreational drug ecstasy

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

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Research Team

J

James C Eisenach, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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Intranasal and Intravenous Oxytocin for Analgesia to Noxious Heat Pain | DecenTrialz