Ignite Creation Date:
2024-05-06 @ 2:48 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04433741
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-01
First Post:
2020-06-11
Brief Title:
Apply the PD Model of Peripheral Oxytocin Action to a Multimodal Stimulus
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Apply the Pharmacodynamic Model of Peripheral Oxytocin Action to a Multimodal Stimulus That Increases Heat or Decreases Vibration Pain Perception
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study of participants that will receive an intravenous IV infusion of oxytocin naturally occurring hormone that is made in the brain
In this study healthy volunteers are recruited Each study participant will have an IV catheter placed After placement of the IV catheter oxytocin will be given by IV infusion of oxytocin or placebo inactive solution The investigators will perform some tests to evaluate how oxytocin changes perceptions on the skin The investigators will study a painful perception by placing a probe on the skin and heating it to 1166 degrees Fahrenheit for 30 seconds and a vibratory stimulus will be applied to the forearm with vibration begun at a 1 kHz frequency and decreased at a rate of 25 Hzsec until the subject first perceives the vibration Each study participant will score any pain that is experienced on a 0 to 10 scale and will report when the vibration is detected Each participant will receive oxytocin and placebo in a random order and will be blinded to group they are receiving
In this study healthy volunteers are recruited Each study participant will have an IV catheter placed After placement of the IV catheter oxytocin will be given by IV infusion of oxytocin or placebo inactive solution The investigators will perform some tests to evaluate how oxytocin changes perceptions on the skin The investigators will study a painful perception by placing a probe on the skin and heating it to 1166 degrees Fahrenheit for 30 seconds and a vibratory stimulus will be applied to the forearm with vibration begun at a 1 kHz frequency and decreased at a rate of 25 Hzsec until the subject first perceives the vibration Each study participant will score any pain that is experienced on a 0 to 10 scale and will report when the vibration is detected Each participant will receive oxytocin and placebo in a random order and will be blinded to group they are receiving
Detailed Description:
The investigators aim to create pharmacokineticpharmacodynamic PKPD models for oxytocin action at peripheral sites and at central sites as they relate to sensory transmission and pain This is the last of 4 studies to accomplish generation validation and application of a PKPD model for oxytocin in the periphery Its goal is to apply the PKPD model generated in previous protocols and Validate a pharmacodynamic model of oxytocin for peripheral analgesic effects to a more complex sensory stimulus that stimulates nerve fibers which result in pain from a heat stimulus and those which reduce pain from vibration similar to brushing or rubbing an area of pain The investigators do this because oxytocin in animals affects these nerve fibers in the periphery in different ways - it increases the activity of the vibrationrubbing sensitive fibers and decreases the activity of the pain fibers As such The investigators expect that the effect of oxytocin on pain from this mixed stimulus of heat and vibration will be much more pronounced than that seen with the purely painful stimulus used in previous studies in this series
This is a double-blind crossover study in which oxytocin or placebo is infused In this study healthy people are recruited for a 2 day double-blind crossover study They will come to the Clinical Research Unit and one intravenous catheter IV inserted in the forearm for oxytocin or placebo infusion Participants will be given a steady rate intravenous infusion of oxytocin at a targeted dose or placebo for 30 minutes At 5 15 and 30 minutes after starting the infusion pain report to the 47Celsius 30-second stimulus alone or with ½ VT vibration randomized order will be obtained Participants will return at least 24 hours later and receive the opposite infusion and testing
This is a double-blind crossover study in which oxytocin or placebo is infused In this study healthy people are recruited for a 2 day double-blind crossover study They will come to the Clinical Research Unit and one intravenous catheter IV inserted in the forearm for oxytocin or placebo infusion Participants will be given a steady rate intravenous infusion of oxytocin at a targeted dose or placebo for 30 minutes At 5 15 and 30 minutes after starting the infusion pain report to the 47Celsius 30-second stimulus alone or with ½ VT vibration randomized order will be obtained Participants will return at least 24 hours later and receive the opposite infusion and testing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None