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

Last updated: January 28, 2025
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

2

Condition

Sun Poisoning

Treatment

oxytocin

placebo

Clinical Study ID

NCT06651476
IRB00120861
5P01NS119159
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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?

Eligibility Criteria

Inclusion

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 priormedical history, and as assessed to be American Society of Anesthesiologistsphysical status 1, 2, or 3

  • Fitzpatrick Scale rating I through III

Exclusion

Exclusion Criteria:

  • History of skin cancer

  • Dark enough skin complexion that would make it infeasible to determine the minimalerythematous dose of UV-B irradiation. Anyone Fitzpatrick Scale score >3 will beexcluded

  • 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 orprolonged 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, orthe recreational drug ecstasy

  • Subjects with a known latex allergy

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: oxytocin
Phase: 2
Study Start date:
December 05, 2024
Estimated Completion Date:
August 01, 2025

Study Description

The goal of this clinical trial is to test whether intravenous oxytocin increases the analgesic effect of vibration on heat pain threshold of skin that has been exposed to Ultraviolet-B (UV-B) burn (mild sunburn). Researchers will compare oxytocin (a hormone that naturally occurs in the body) to a placebo (a look-alike substance that contains no drug) to see if oxytocin works to increase the pain threshold (the lowest intensity at which one begins to perceive or sense a stimulus as being painful).

Connect with a study center

  • Atrium Health Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

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