Intranasal and Intravenous Oxytocin for Analgesia to Noxious Heat Pain

NCT ID: NCT07053774

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-05
• Study Completion Date: 2026-09-30

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.

Detailed Description

This protocol will utilize a randomized, triple-masked, cross-over study design to compare intravenous (IV) to intranasal (IN) oxytocin administration for analgesia to an experimental pain stimulus in healthy volunteers. Equal numbers of adult men and women; ages 18-55 will be recruited. Participants will report to the research unit for three visits, 1) screening, informed consent, pregnancy test, and training to consistently rate pain from an FDA-approved device to test heat pain. The lowest temperature which causes a pain score of greater than 2 with 5 minutes of heating will be identified, 2) intravenous infusion and self-administered intranasal spray of study drug and 5-minute heat testing at intervals for 4 hours, 3) a repeat of the procedures done at visit two.

Participants will receive intravenous oxytocin, 20 IU and intranasal placebo on one of these visits and intravenous placebo and intranasal oxytocin, 48 IU, on the other. Pain score at the end of 5-minute skin heating will be compared using mathematical modeling of the time course of change in each individual and in the study population as a whole. The effect, if any, on these models of participant age, sex, and weight will be explored.

Conditions

Pain, Acute

Keywords

healthy volunteers; pain control; oxytocin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

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

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..

Group Type: EXPERIMENTAL

Intravenous oxytocin

Intervention Type: 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.

Intravenous placebo

Intervention Type: 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.

Intranasal oxytocin

Intervention Type: 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.

Intranasal placebo

Intervention Type: 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.

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

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.

Group Type: EXPERIMENTAL

Intravenous oxytocin

Intervention Type: 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.

Intravenous placebo

Intervention Type: 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.

Intranasal oxytocin

Intervention Type: 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.

Intranasal placebo

Intervention Type: 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.

Interventions

Intravenous oxytocin

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.

Intervention Type: DRUG

Intravenous placebo

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.

Intervention Type: DRUG

Intranasal oxytocin

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.

Intervention Type: DRUG

Intranasal placebo

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.

Intervention Type: DRUG

Other Intervention Names

Pitocin; Normal saline; Pitocin; Excipients: chlorobutanol, methylparaben, propylparaben, dibasic sodium phosphate, anhydrous citric acid, sorbitol, glycerin, and sterile water

Eligibility Criteria

Inclusion Criteria

• Male or female > 18 and ≤55 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James C Eisenach, MD

Role: PRINCIPAL_INVESTIGATOR

Atrium Health Wake Forest Baptist

Locations

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

James C Eisenach, MD

Role: CONTACT

Phone: 336-716-4182

Email: eisenach@wakehealth.edu

Facility Contacts

Regina Curry, RN

Role: primary

Other Identifiers

40010559

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00134089

Identifier Type: -

Identifier Source: org_study_id