CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Low dose oxytocin +1 moredrug
Likely dose
Low dose oxytocin 1.3 microgramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05179421
NCT05179421Phase 2Completed

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

Wake Forest University Health Sciences·interventional·Posted Jan 5, 2022·Updated Mar 19, 2024

In Brief

A Phase 2 clinical trial evaluating Low dose oxytocin and High dose oxytocin for Healthy Volunteer Study. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJan 5, 2022
Enrollment StartMay 9, 2022
Primary CompletionFeb 10, 2023
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 4.5 years ago

Interventions

Low dose oxytocindrug

10 minute IV infusion of saline followed by a 10 minute infusion of oxytocin 1.3 micrograms

High dose oxytocindrug

10 minute IV infusion of oxytocin 0.3 micrograms followed by a 10 minute infusion of oxytocin 7 micrograms