A Randomized Controlled Trial to Test Whether Oxytocin Amplifies the Effect of Vibration to Increase Heat Pain Threshold After UV-B Burn
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:
• 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
Locations
United States
North Carolina
Atrium Health Wake Forest Baptist Medical Center
RECRUITING
Winston-salem
Contact Information
Primary
Regina Curry, RN
recurry@wakehealth.edu
336-716-4294
Time Frame
Start Date: 2024-12-05
Estimated Completion Date: 2025-08-01
Participants
Target number of participants: 36
Treatments
Experimental: oxytocin
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.
Placebo_comparator: placebo
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.
Related Therapeutic Areas
Sponsors
Leads: Wake Forest University Health Sciences
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)