Dose Ranging Study of Intravenous Oxytocin for Analgesia to Heat Pain

  • STATUS
    Recruiting
  • days left to enroll
    86
  • participants needed
    24
  • sponsor
    Wake Forest University Health Sciences
Updated on 24 May 2022
Accepts healthy volunteers

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.

Description

Equal numbers of adult men and women will be recruited. Sample size will be divided into 3 groups; 8 subjects per group: young (18-39-year-old) middle (40 - 59-year-old) and older (60

  • 75-year-old).

Participants will report to the research unit for three visits, 1) screening and informed consent 2) study medication infusions and thermal heat testing 3) study medication infusions and thermal heat testing separated by at least 72 hours.

For study infusion visits, study participants will come to the Clinical Research Unit and one intravenous (IV) catheter will be inserted in the forearm for oxytocin infusions. Participants in this study will receive a dose of oxytocin or placebo at a steady rate for 10 minutes; one hour later, a second dose of oxytocin will be administered during one visit. During the second study infusion visit, a lower dose of oxytocin will be given by a 10-minute IV infusion and one hour later a second infusion of oxytocin at a higher dose will be given. The order of infusions will be randomized and double-blinded. As a result, each participant will receive oxytocin doses of 0, 0.3, 1.3, and 7 micrograms(µg) in this double blind design.

Details
Condition Healthy Volunteer Study
Treatment saline (placebo) then oxytocin 1.3 micrograms, Experimental: oxytocin 0.3 micrograms then oxytocin 7 micrograms
Clinical Study IdentifierNCT05179421
SponsorWake Forest University Health Sciences
Last Modified on24 May 2022

Eligibility

Yes No Not Sure

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 current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval
Subjects with past or current history of hyponatremia or at risk for hyponatremia; anyone taking thiazide diuretics, loop diuretics, combination diuretics, lithium, carbamazepine, enalapril, Ramipril, celecoxib, temazepam, gliclazide, glimepiride, glibenclamide, glipizide, omeprazole, pantoprazole, desmopressin, SSRI's, MAOI, or the recreational drug ecstasy
Subjects with a known latex allergy
Subjects with a pain score rating of 1 or less during the initial training session to a 5 minute heating of 45°C- 47 °C to the lower calf
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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