A Randomized Controlled Trial to Test the Effects Oxytocin and Vibration Have on Heat Pain Threshold After UV-B Burn

NCT06651476 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: IRB001208615P01NS119159
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to answer the question: Does oxytocin increase the pain threshold on thermal heat pain in the presence of vibration on an area of skin exposed to a mild sunburn?

Conditions

Sunburn

Keywords

healthy volunteer; UVB burn; burn pain

Outcome Measures

Primary Outcomes (1)

• Difference between heat pain threshold

  Difference between heat pain threshold at 24 hours after Ultraviolet-B (UV-B) exposure at 3x minimum erythematous dose. The difference between the average threshold for stimuli #5-8 and the average threshold for stimuli #13-17 at baseline and 2 hours after the beginning of the oxytocin or placebo infusion will be used. The values are measured in degrees Celsius. A lower temperature indicates more sensitivity to heat pain.

  24 hours after UV-B exposure

Secondary Outcomes (3)

• Difference between heat pain threshold

  Two days after UV-B exposure

• Touch and pain threshold to von Frey filament application

  24 hours after UV-B exposure

• Touch and pain threshold to von Frey filament application

  Two days after UV-B exposure

Study Arms (2)

oxytocin

EXPERIMENTAL

Two 30 minute infusions of oxytocin, 10 International Units (IU) separated by 30 minutes. To avoid potential unmasking by facial flushing which can occur at the beginning of high rates of oxytocin administration, the first infusion will consist of two steps beginning with a rate of 0.125 IU oxytocin per minute for 5 minutes, then increased to 0.375 IU oxytocin for 25 minutes. The second infusion will be a constant rate of 0.333 IU oxytocin per minute for 30 minutes.

Drug: oxytocin

placebo

PLACEBO COMPARATOR

Two 30 minute infusions of placebo separated by 30 minutes. The first infusion will consist of two steps, using an equivalent volume of placebo fluid infusion as in the oxytocin arm. This will consist of a slower rate in the first 5 minutes and more rapid rate for the last 25 min. The second placebo solution infusion will be a constant rate and volume equivalent to that used in the oxytocin arm.

Drug: placebo

Interventions

oxytocin DRUG

Oxytocin 10 IU will be administered over 30 minutes by intravenous infusion and repeated 30 minutes after the end of the first infusion.

oxytocin

placebo DRUG

A placebo will be administered over 30 minutes by intravenous infusion and repeated 30 minutes after the end of the first infusion.

placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Fitzpatrick Scale rating I through III

You may not qualify if:

• History of skin cancer
• Dark enough skin complexion that would make it infeasible to determine the minimal erythematous dose of UV-B irradiation. Anyone Fitzpatrick Scale score \>3 will be excluded
• Neuropathy, chronic pain (located in any body location that is being treated), diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis
• Pregnancy or currently breast feeding
• Subjects with current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval
• Subjects with 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, SSRI's, MAOI, or the recreational drug ecstasy
• Subjects with a known latex allergy

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Sunburn; Pain

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Photosensitivity Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Burns; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• James C Eisenach, M.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 21, 2024
• Study Start: December 5, 2024
• Primary Completion: November 20, 2025
• Study Completion: November 20, 2025
• Last Updated: January 12, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)