A Randomized Controlled Trial to Test the Effects Oxytocin and Vibration Have on Heat Pain Thresh… (NCT06651476) | Clinical Trial Compass
CompletedPhase 2
A Randomized Controlled Trial to Test the Effects Oxytocin and Vibration Have on Heat Pain Threshold After UV-B Burn
United States38 participantsStarted 2024-12-05
Plain-language 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?
Who can participate
Age range18 Years – 55 Years
SexALL
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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