NCT05179421

Dose Ranging Study of Intravenous Oxytocin for Analgesia to Heat Pain

A Dose Ranging Study for a Pharmacodynamic Model of Oxytocin for Peripheral Analgesia Effects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

Equal numbers of adult men and women; ages 18-75 will be recruited. 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. On one study day the doses will by 0 and 1.3 micrograms (µg) and on the other study day the doses will be 0.3 and 7 µg oxytocin. The order of study days will be randomized and double-blinded. As a result, each participant will receive oxytocin doses of 0, 0.3, 1.3, and 7 µg in this double blind design.

Conditions

• Healthy Volunteer Study

Interventions

Type	Name	Description
DRUG	Low dose oxytocin	10 minute IV infusion of saline followed by a 10 minute infusion of oxytocin 1.3 micrograms
DRUG	High dose oxytocin	10 minute IV infusion of oxytocin 0.3 micrograms followed by a 10 minute infusion of oxytocin 7 micrograms

Timeline

• Start date: 2022-05-09
• Primary completion: 2023-02-10
• Completion: 2023-02-10
• First posted: 2022-01-05
• Last updated: 2024-03-19
• Results posted: 2024-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study