Intranasal and Intravenous Oxytocin for Analgesia to Noxious Heat Pain

NCT07053774 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: IRB0013408940010559
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Acute

Keywords

healthy volunteers; pain control; oxytocin

Outcome Measures

Primary Outcomes (2)

• Pain Scale Score - End of 5-minute Skin Heating

  Change in verbal pain scale score. Range is 0-10. 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable.

  Baseline Up to Hour 4.5

• Pain Scale Score - During Skin Heating

  Verbal pain scale range is 0-10. 0 is equivalent to no pain and 10 is equivalent to the worst pain imaginable.

  Minute 5 During Skin Heating

Secondary Outcomes (4)

• Pain Scale Score - During Skin Heating

  Minute 1 During Skin Heating

• Pain Scale Score - During Skin Heating

  Minute 2 During Skin Heating

• Pain Scale Score - During Skin Heating

  Minute 3 During Skin Heating

• Pain Scale Score - During Skin Heating

  Minute 4 During Skin Heating

Study Arms (2)

Intravenous (IV) oxytocin and intranasal (IN) placebo first

EXPERIMENTAL

On Visit 2 participants will receive IV infusion of oxytocin. At the beginning of the IV infusion, the participant will self-administer IN placebo. On Visit 3 participants will receive IV infusion of placebo. At the beginning of the IV infusion, the participant will self-administer IN oxytocin..

Drug: Intravenous oxytocin; Drug: Intravenous placebo; Drug: Intranasal oxytocin; Drug: Intranasal placebo

Intravenous (IV) placebo and intranasal (IN) oxytocin first

EXPERIMENTAL

On Visit 2 participant will receive IV infusion of placebo. At the beginning of the IV infusion, the participants will self-administer IN oxytocin. On Visit 3 participants will receive IV infusion of oxytocin. At the beginning of the IV infusion, the participant will self-administer IN placebo.

Drug: Intravenous oxytocin; Drug: Intravenous placebo; Drug: Intranasal oxytocin; Drug: Intranasal placebo

Interventions

Intravenous oxytocin DRUG

Oxytocin, 10 International Units (IU) will be administered by IV infusion over 30 minutes and, 30 minutes later, a second 10 IU will be administered over 30 min, for a total dose of 20 IU. The first infusion will be at a rate of 0.125 IU/min for the first 5 min, then at 0.375 IU/min for the remaining 25 min. The second 30-min infusion will be at a fixed rate of 0.333 IU/min.

Also known as: Pitocin

Intravenous (IV) oxytocin and intranasal (IN) placebo first; Intravenous (IV) placebo and intranasal (IN) oxytocin first

Intravenous placebo DRUG

Saline will be administered as two 30-min IV infusions separated by 30-min, using the same volume of infusion solution and rates of administration as in the intravenous oxytocin intervention.

Also known as: Normal saline

Intravenous (IV) oxytocin and intranasal (IN) placebo first; Intravenous (IV) placebo and intranasal (IN) oxytocin first

Intranasal oxytocin DRUG

Oxytocin will be self-administered at the time the first IV infusion begins as a single 0.1 mL spray (12 IU) in each nostril followed in 5 min by another spray in each nostril. The total dose of oxytocin is 48 IU.

Also known as: Pitocin

Intravenous (IV) oxytocin and intranasal (IN) placebo first; Intravenous (IV) placebo and intranasal (IN) oxytocin first

Intranasal placebo DRUG

Placebo (solution containing the excipients in the oxytocin solution but without oxytocin) will be self-administered at the time the first IV infusion begins as a single 0.1 mL spray in each nostril followed in 5 min by another spray in each nostril.

Also known as: Excipients: chlorobutanol, methylparaben, propylparaben, dibasic sodium phosphate, anhydrous citric acid, sorbitol, glycerin, and sterile water

Intravenous (IV) oxytocin and intranasal (IN) placebo first; Intravenous (IV) placebo and intranasal (IN) oxytocin first

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Acute Pain; Agnosia

Interventions

Oxytocin; Saline Solution; methylparaben; propylparaben; sodium phosphate; Citric Acid; Sorbitol; Glycerol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Sugar Alcohols; Alcohols; Carbohydrates; Triose Sugar Alcohols

Study Officials

• James C Eisenach, MD

  Atrium Health Wake Forest Baptist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James C Eisenach, MD

CONTACT

336-716-4182; eisenach@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Wake Forest University School of Medicine research pharmacy will prepare solutions and dispense them on the day of each study using a randomization stratified by sex that will be concealed until the end of the clinical trial.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will receive an intravenous (IV) infusion of study drug and self-administer intranasal study drug. At study visit two some participants will receive IV saline (placebo) and oxytocin (48 IU) intranasally and some will receive IV oxytocin (20 IU) saline (placebo) intranasally. At visit three, participants will receive the opposite treatment sequence they received at visit 2. The order of study days will be randomized.

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: November 5, 2025
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: March 30, 2026

Record last verified: 2025-06

Locations

US (1)