Testing oxytocin and vibration effects on pain from sunburn
A Randomized Controlled Trial to Test Whether Oxytocin Amplifies the Effect of Vibration to Increase Heat Pain Threshold After UV-B Burn
This study is testing if a hormone called oxytocin, combined with vibration therapy, can help people with mild sunburn feel less pain.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT06651476 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether intravenous oxytocin can enhance the pain threshold in individuals experiencing mild sunburn when combined with vibration therapy. Participants will be randomly assigned to receive either oxytocin or a placebo, and their pain responses will be measured after exposure to UV-B light. The study aims to determine if oxytocin, a naturally occurring hormone, can provide additional analgesic benefits in this context. The trial will include healthy volunteers aged 18 to 55 with specific skin types and health criteria.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 55 with a Fitzpatrick skin type rating of I to III.
Not a fit: Patients with darker skin types, chronic pain conditions, or a history of certain cardiovascular issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new method for managing pain associated with sunburn.
How similar studies have performed: While the combination of oxytocin and vibration therapy is a novel approach, similar studies have shown promise in pain management, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Winston-Salem, North Carolina
- Atrium Health Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: James C Eisenach, M.D. — Wake Forest University Health Sciences
- Study coordinator: Regina Curry, RN
- Email: recurry@wakehealth.edu
- Phone: 336-716-4294
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.