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Generate and Test the Reliability of a PD Model of OXT on Pupillary Hippus as a Measure of CNS Activity

Primary Purpose

Chronic Pain, Osteoarthritis, Knee

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Oxytocin

Placebo

About this trial

This is an interventional basic science trial for Chronic Pain

Eligibility Criteria

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

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, 2, or 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. For knee arthritis subjects, normal blood pressure or, for those with hypertension, pressure controlled with anti-hypertensives and with a resting heart rate 45-100 beats per minute.
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.
Subjects with eye pathology, eye surgery, or taking topical eye medications, or any disease process that would cause motor tremors or excessive eye movements.

Sites / Locations

Wake Forest Baptist HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Oxytocin First, then Placebo

Placebo, Then Oxytocin

Arm Description

Subjects in this arm will receive Intramuscular injection of Oxytocin (Pitocin®) first then placebo injection.

Subjects in this arm will receive Intramuscular placebo injection first then oxytocin injection

Outcomes

Primary Outcome Measures

Fluctuation in Pupil Diameter (Hippus) -Pre drug administration

Magnitude of power at the dominant frequency in the Fourier transform of pupil diameter. One measure of coefficient of variation at each time period. It is calculated by the amount of variability in a window of time. Every 2.5 minutes beginning 20 minutes before the intramuscular injection of placebo or oxytocin, 25 micrograms.

Fluctuation in Pupil Diameter (Hippus) -Post drug administration

Magnitude of power at the dominant frequency in the Fourier transform of pupil diameter. One measure of coefficient of variation at each time period. It is calculated by the amount of variability in a window of time. Every 2.5 minutes for 180 after intramuscular injection of placebo or oxytocin, 25 micrograms.

Secondary Outcome Measures

Full Information

NCT ID

NCT04427709

First Posted

June 9, 2020

Last Updated

May 2, 2023

Sponsor

Wake Forest University Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT04427709

Brief Title

Generate and Test the Reliability of a PD Model of OXT on Pupillary Hippus as a Measure of CNS Activity

Official Title

Generate and Test the Reliability of a Pharmacodynamic Model of Oxytocin on Pupillary Hippus as a Measure of Central Nervous System Activity

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 30, 2020 (Actual)

Primary Completion Date

January 2025 (Anticipated)

Study Completion Date

January 2025 (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

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this research is to evaluate the effects of oxytocin (naturally occurring hormone) given by an intramuscular (IM; into the muscle) injection, has on your parasympathetic nervous system. The parasympathetic nervous system is the part of the involuntary nervous system that is sometimes called the "rest and digest" system; the parasympathetic system conserves energy as it slightly slows the heart rate, increases intestinal and gland activity, and relaxes sphincter muscles in the gastrointestinal tract.

Detailed Description

This is a single site study at Wake Forest School of Medicine. Healthy volunteers and patients with advanced knee arthritis being seen in the Orthopedic Clinic in consultation for potential total knee arthroplasty will be recruited after their doctor visit if the decision is made not to perform surgery at this time. Study participants will come to the Pain Clinical Research Unit on 2 occasions. On these visits, they will receive an intramuscular (i.m.) injection of placebo or oxytocin, 25 micrograms (μg) (Pitocin®), obtained from the research pharmacy. The order in this cross-over study will be randomized and double blind, and the studies separated by at least 48 hours. Every 2.5 minutes beginning 20 minutes before injection and until 180 minutes after injection oscillation in pupil diameter at low frequency (hippus) will be obtained using an infrared pupilometer, in which they focus on a central point of gaze for 20 seconds. Hippus, a measure of parasympathetic output to the pupil and affected by central actions of oxytocin as described in preliminary data, will be calculated as the magnitude of power in the 0-0.25 Hertz (Hz) bin of the spectral analysis of pupil diameter, after removing blink and saccade artifacts. After 180 minutes the study participant will be discharged from the Pain Clinical Research Unit.

6. Conditions and Keywords

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

Chronic Pain, Osteoarthritis, Knee

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Model Description

Randomized, double blind, crossover study. Each participant will receive Oxytocin 25 micrograms and placebo via intramuscular injection

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Randomization will be maintained by the research pharmacist and by an independent individual not affiliated with the data collection or outcome evaluation

Allocation

Randomized

Enrollment

38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Oxytocin First, then Placebo

Arm Type

Other

Arm Description

Subjects in this arm will receive Intramuscular injection of Oxytocin (Pitocin®) first then placebo injection.

Arm Title

Placebo, Then Oxytocin

Arm Type

Other

Arm Description

Subjects in this arm will receive Intramuscular placebo injection first then oxytocin injection

Intervention Type

Drug

Intervention Name(s)

Oxytocin

Other Intervention Name(s)

Pitocin

Intervention Description

Intramuscular injection of Oxytocin (Pitocin®)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Intramuscular placebo injection

Primary Outcome Measure Information:

Title

Fluctuation in Pupil Diameter (Hippus) -Pre drug administration

Description

Time Frame

Baseline before study drug administration

Title

Fluctuation in Pupil Diameter (Hippus) -Post drug administration

Description

Magnitude of power at the dominant frequency in the Fourier transform of pupil diameter. One measure of coefficient of variation at each time period. It is calculated by the amount of variability in a window of time. Every 2.5 minutes for 180 after intramuscular injection of placebo or oxytocin, 25 micrograms.

Time Frame

up to 180 minutes after study drug administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

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, 2, or 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. For knee arthritis subjects, normal blood pressure or, for those with hypertension, pressure controlled with anti-hypertensives and with a resting heart rate 45-100 beats per minute. 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. Subjects with eye pathology, eye surgery, or taking topical eye medications, or any disease process that would cause motor tremors or excessive eye movements.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Regina Curry, RN

Phone

336-716-4294

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

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Regina Curry, RN

Phone

336-716-4294

RECURRY@WAKEHEALTH.EDU

First Name & Middle Initial & Last Name & Degree

James C Eisenach, M.D.

12. IPD Sharing Statement

Plan to Share IPD

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Generate and Test the Reliability of a PD Model of OXT on Pupillary Hippus as a Measure of CNS Activity

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