- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04427709
Generate and Test the Reliability of a PD Model of OXT on Pupillary Hippus as a Measure of CNS Activity
Generate and Test the Reliability of a Pharmacodynamic Model of Oxytocin on Pupillary Hippus as a Measure of Central Nervous System Activity
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Regina Curry, RN
- Phone Number: 336-716-4294
- Email: RECURRY@WAKEHEALTH.EDU
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Wake Forest Baptist Health
-
Contact:
- Regina Curry, RN
- Phone Number: 336-716-4294
- Email: RECURRY@WAKEHEALTH.EDU
-
Principal Investigator:
- James C Eisenach, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Oxytocin First, then Placebo
Subjects in this arm will receive Intramuscular injection of Oxytocin (Pitocin®) first then placebo injection.
|
Intramuscular injection of Oxytocin (Pitocin®)
Other Names:
Intramuscular placebo injection
|
Other: Placebo, Then Oxytocin
Subjects in this arm will receive Intramuscular placebo injection first then oxytocin injection
|
Intramuscular injection of Oxytocin (Pitocin®)
Other Names:
Intramuscular placebo injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fluctuation in Pupil Diameter (Hippus) -Pre drug administration
Time Frame: Baseline before study 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. |
Baseline before study drug administration
|
Fluctuation in Pupil Diameter (Hippus) -Post drug administration
Time Frame: up to 180 minutes after study 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. |
up to 180 minutes after study drug administration
|
Collaborators and Investigators
Investigators
- Principal Investigator: James C Eisenach, MD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00066475
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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