Clinical trial NCT06651476: A Randomized Controlled Trial to Test the Effects Oxytocin and Vibration Have on Heat Pain Threshold After UV-B Burn
Official title: A Randomized Controlled Trial to Test Whether Oxytocin Amplifies the Effect of Vibration to Increase Heat Pain Threshold After UV-B Burn
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Sunburn
Keywords: healthy volunteer
UVB burn
burn pain
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2024-10-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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?

Detailed 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).

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
* Fitzpatrick Scale rating I through III

Exclusion Criteria:

* 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

Primary outcomes:
measure: Difference between heat pain threshold
timeFrame: 24 hours after UV-B exposure
Secondary outcomes:
measure: Difference between heat pain threshold
timeFrame: Two days after UV-B exposure
measure: Touch and pain threshold to von Frey filament application
timeFrame: 24 hours after UV-B exposure
measure: Touch and pain threshold to von Frey filament application
timeFrame: Two days after UV-B exposure
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: James C Eisenach, M.D.
role: PRINCIPAL_INVESTIGATOR
References: