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Apply the PD Model of Peripheral Oxytocin Action to a Multimodal Stimulus

Primary Purpose

Pain, Chronic

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Placebo
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain, Chronic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Male or female > 18 and < 75 years of age, Body Mass Index (BMI) <40.
  2. Generally in good health as determined by the Principal Investigator based on prior medical history, American Society of Anesthesiologists physical status 1 or 2.
  3. For healthy volunteers, normal blood pressure (systolic 90-140 mmHg; diastolic 50-90 mmHg) resting heart rate 45-100 beats per minute) without medication.
  4. Female subjects of child-bearing potential and those < 1 year post-menopausal, must be practicing highly effective methods of birth control such as hormonal methods (e.g., combined oral, implantable, injectable, or transdermal contraceptives), double barrier methods (e.g., condoms, sponge, diaphragm, or vaginal ring plus spermicidal jellies or cream), or total abstinence from heterosexual intercourse for a minimum of 1 full cycle before study drug administration.

Exclusion Criteria:

  1. Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®
  2. Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data
  3. Women who are pregnant (positive result for serum pregnancy test at screening visit), women who are currently nursing or lactating, women that have been pregnant within 2 years
  4. Subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.

Sites / Locations

  • Wake Forest Baptist Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Oxytocin First, then Placebo

Placebo, Then Oxytocin

Arm Description

Oxytocin administered intravenously for the first half of the study and then will receive intravenous placebo for the second half.

Placebo administered intravenously for the first half of the study and then will receive intravenous oxytocin for the second half.

Outcomes

Primary Outcome Measures

Heat pain with vibration
Pain at the end of 30 sec of heating the skin to 47 degrees C with simultaneous vibration will be determined. Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
Heat pain with vibration
Pain at the end of 30 sec of heating the skin to 47 degrees C with simultaneous vibration will be determined. Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
Heat pain with vibration
Pain at the end of 30 sec of heating the skin to 47 degrees C with simultaneous vibration will be determined. Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
Heat pain with vibration
Pain at the end of 30 sec of heating the skin to 47 degrees C with simultaneous vibration will be determined. Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.

Secondary Outcome Measures

Heat pain without vibration
Pain at the end of 30 sec of heating the skin to 47 degrees C will be determined. Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
Heat pain without vibration
Pain at the end of 30 sec of heating the skin to 47 degrees C will be determined. Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
Heat pain without vibration
Pain at the end of 30 sec of heating the skin to 47 degrees C will be determined. Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
Heat pain without vibration
Pain at the end of 30 sec of heating the skin to 47 degrees C will be determined. Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.

Full Information

First Posted
June 11, 2020
Last Updated
May 2, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04433741
Brief Title
Apply the PD Model of Peripheral Oxytocin Action to a Multimodal Stimulus
Official Title
Apply the Pharmacodynamic Model of Peripheral Oxytocin Action to a Multimodal Stimulus That Increases (Heat) or Decreases (Vibration) Pain Perception
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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 116.6 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 Hz/sec 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 pharmacokinetic/pharmacodynamic (PK/PD) 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 PK/PD model for oxytocin in the periphery. Its goal is to apply the PK/PD 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 vibration/rubbing 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 47°Celsius, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Cross over model: each participant will be randomized to receive oxytocin and placebo in a random order
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Participant, outcomes assessor and investigator will be blinded to the randomization order. Research pharmacist will prepare each infusion.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin First, then Placebo
Arm Type
Other
Arm Description
Oxytocin administered intravenously for the first half of the study and then will receive intravenous placebo for the second half.
Arm Title
Placebo, Then Oxytocin
Arm Type
Other
Arm Description
Placebo administered intravenously for the first half of the study and then will receive intravenous oxytocin for the second half.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Pitocin
Intervention Description
Oxytocin administered intravenously
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered intravenously
Primary Outcome Measure Information:
Title
Heat pain with vibration
Description
Pain at the end of 30 sec of heating the skin to 47 degrees C with simultaneous vibration will be determined. Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
Time Frame
Baseline before infusion
Title
Heat pain with vibration
Description
Pain at the end of 30 sec of heating the skin to 47 degrees C with simultaneous vibration will be determined. Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
Time Frame
5 minutes post infusion initiation
Title
Heat pain with vibration
Description
Pain at the end of 30 sec of heating the skin to 47 degrees C with simultaneous vibration will be determined. Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
Time Frame
15 minutes post infusion initiation
Title
Heat pain with vibration
Description
Pain at the end of 30 sec of heating the skin to 47 degrees C with simultaneous vibration will be determined. Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
Time Frame
30 minutes post infusion initiation
Secondary Outcome Measure Information:
Title
Heat pain without vibration
Description
Pain at the end of 30 sec of heating the skin to 47 degrees C will be determined. Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
Time Frame
Baseline
Title
Heat pain without vibration
Description
Pain at the end of 30 sec of heating the skin to 47 degrees C will be determined. Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
Time Frame
5 minutes post infusion initiation
Title
Heat pain without vibration
Description
Pain at the end of 30 sec of heating the skin to 47 degrees C will be determined. Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
Time Frame
15 minutes post infusion initiation
Title
Heat pain without vibration
Description
Pain at the end of 30 sec of heating the skin to 47 degrees C will be determined. Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
Time Frame
30 minutes post infusion initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female > 18 and < 75 years of age, Body Mass Index (BMI) <40. Generally in good health as determined by the Principal Investigator based on prior medical history, American Society of Anesthesiologists physical status 1 or 2. For healthy volunteers, normal blood pressure (systolic 90-140 mmHg; diastolic 50-90 mmHg) resting heart rate 45-100 beats per minute) without medication. Female subjects of child-bearing potential and those < 1 year post-menopausal, must be practicing highly effective methods of birth control such as hormonal methods (e.g., combined oral, implantable, injectable, or transdermal contraceptives), double barrier methods (e.g., condoms, sponge, diaphragm, or vaginal ring plus spermicidal jellies or cream), or total abstinence from heterosexual intercourse for a minimum of 1 full cycle before study drug administration. Exclusion Criteria: Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin® Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data Women who are pregnant (positive result for serum pregnancy test at screening visit), women who are currently nursing or lactating, women that have been pregnant within 2 years Subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Regina Curry, RN
Phone
336-716-4294
Email
RECURRY@WAKEHEALTH.EDU
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James C Eisenach, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regina Curry, RN
Phone
336-716-4294
Email
RECURRY@WAKEHEALTH.EDU
First Name & Middle Initial & Last Name & Degree
James C Eisenach, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Apply the PD Model of Peripheral Oxytocin Action to a Multimodal Stimulus

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