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Clinical Trial Summary

This is a study of participants that will receive intravenous (IV) infusions of oxytocin (naturally occurring hormone that is made by the brain). In this study healthy participants will be recruited for the study. There will be 3 study related visits: 1) screening and informed consent 2) study medication infusions and thermal heat testing 3) study medication infusions and thermal heat testing. During study visits 2 and 3 an IV catheter will be placed and a dose of oxytocin or placebo (inactive solution) will be given over a 10 minute period; 1 hour after the first infusion, a second 10 minute infusion of oxytocin will be administered. Investigators will perform some tests to evaluate how oxytocin changes perceptions of the skin. Investigators will study a painful perception by placing a probe on the skin of the side of lower leg and heating it up to 113-117 degrees Fahrenheit (F) (45-47 degrees Celsius (C)) for 5 minutes. Each participant will score any pain that is experienced on a 0 to 10 scale for each minute during the heating period. Most people find that pain rises during the 5 minutes, but remains mild; usually less than 5 on the 0 to 10 pain scale. The temperature of the 5 minute heating will be determined according to the participants pain rating during the screening visit. The primary objective of the study is to determine the dose response of IV oxytocin for analgesia (pain relief) to experimental heat pain.

Clinical Trial Description

Equal numbers of adult men and women will be recruited. Sample size will be divided into 3 groups; 8 subjects per group: young (18-39-year-old) middle (40 - 59-year-old) and older (60 - 75-year-old). Participants will report to the research unit for three visits, 1) screening and informed consent 2) study medication infusions and thermal heat testing 3) study medication infusions and thermal heat testing separated by at least 72 hours. For study infusion visits, study participants will come to the Clinical Research Unit and one intravenous (IV) catheter will be inserted in the forearm for oxytocin infusions. Participants in this study will receive a dose of oxytocin or placebo at a steady rate for 10 minutes; one hour later, a second dose of oxytocin will be administered during one visit. During the second study infusion visit, a lower dose of oxytocin will be given by a 10-minute IV infusion and one hour later a second infusion of oxytocin at a higher dose will be given. The order of infusions will be randomized and double-blinded. As a result, each participant will receive oxytocin doses of 0, 0.3, 1.3, and 7 micrograms(µg) in this double blind design. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05179421
Study type Interventional
Source Wake Forest University Health Sciences
Contact Regina Curry, RN
Phone 336-716-4294
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date January 2022
Completion date February 2023

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