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Purpose

The goal of this research study is to find out how well oxytocin works to reduce pain. Oxytocin will be given intravenously (IV) and as a nasal spray. The study team also hopes to find out if the participants age, weight, or sex effects how well the study drug works. Participants will be exposed to a heater on the skin at a training visit and rate how much pain different temperatures cause. On two separate visits, participants will use a nasal spray and get an IV infusion. After the IV and nasal spray, participants will rate the pain of the same skin heating temperature at various time points for 4 hours.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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, and as assessed to be American Society of Anesthesiologists physical status 1, 2, or 3.

Exclusion Criteria

  • Recent (<3 months) nasal surgery or chronic conditions requiring daily intranasal (IN) medications - Hypersensitivity to any ingredient in Pitocin® (marketed preparation of oxytocin for parenteral injection) - Latex allergy - Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (e.g., active gynecologic disease in which increased tone would be detrimental such as uterine fibroids with ongoing bleeding) - Women who are pregnant, are currently nursing or lactating, or have been pregnant within 2 years - Neuropathy, chronic pain (located in any body location that is being treated), diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis. - Current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval. - 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, serotonin selective reuptake inhibitors (SSRI's), monamine oxidase inhibitors (MAOI), or the recreational drug ecstasy.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Each participant will receive an intravenous (IV) infusion of study drug and self-administer intranasal study drug. At study visit two some participants will receive IV saline (placebo) and oxytocin (48 IU) intranasally and some will receive IV oxytocin (20 IU) saline (placebo) intranasally. At visit three, participants will receive the opposite treatment sequence they received at visit 2. The order of study days will be randomized.
Primary Purpose
Basic Science
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
The Wake Forest University School of Medicine research pharmacy will prepare solutions and dispense them on the day of each study using a randomization stratified by sex that will be concealed until the end of the clinical trial.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Intravenous (IV) oxytocin and intranasal (IN) placebo first 		On Visit 2 participants will receive IV infusion of oxytocin. At the beginning of the IV infusion, the participant will self-administer IN placebo. On Visit 3 participants will receive IV infusion of placebo. At the beginning of the IV infusion, the participant will self-administer IN oxytocin..
  • Drug: Intravenous oxytocin
    Oxytocin, 10 International Units (IU) will be administered by IV infusion over 30 minutes and, 30 minutes later, a second 10 IU will be administered over 30 min, for a total dose of 20 IU. The first infusion will be at a rate of 0.125 IU/min for the first 5 min, then at 0.375 IU/min for the remaining 25 min. The second 30-min infusion will be at a fixed rate of 0.333 IU/min.
    Other names:
    • Pitocin
  • Drug: Intravenous placebo
    Saline will be administered as two 30-min IV infusions separated by 30-min, using the same volume of infusion solution and rates of administration as in the intravenous oxytocin intervention.
    Other names:
    • Normal saline
  • Drug: Intranasal oxytocin
    Oxytocin will be self-administered at the time the first IV infusion begins as a single 0.1 mL spray (12 IU) in each nostril followed in 5 min by another spray in each nostril. The total dose of oxytocin is 48 IU.
    Other names:
    • Pitocin
  • Drug: Intranasal placebo
    Placebo (solution containing the excipients in the oxytocin solution but without oxytocin) will be self-administered at the time the first IV infusion begins as a single 0.1 mL spray in each nostril followed in 5 min by another spray in each nostril.
    Other names:
    • Excipients: chlorobutanol, methylparaben, propylparaben, dibasic sodium phosphate, anhydrous citric acid, sorbitol, glycerin, and sterile water
Experimental
Intravenous (IV) placebo and intranasal (IN) oxytocin first 		On Visit 2 participant will receive IV infusion of placebo. At the beginning of the IV infusion, the participants will self-administer IN oxytocin. On Visit 3 participants will receive IV infusion of oxytocin. At the beginning of the IV infusion, the participant will self-administer IN placebo.
  • Drug: Intravenous oxytocin
    Oxytocin, 10 International Units (IU) will be administered by IV infusion over 30 minutes and, 30 minutes later, a second 10 IU will be administered over 30 min, for a total dose of 20 IU. The first infusion will be at a rate of 0.125 IU/min for the first 5 min, then at 0.375 IU/min for the remaining 25 min. The second 30-min infusion will be at a fixed rate of 0.333 IU/min.
    Other names:
    • Pitocin
  • Drug: Intravenous placebo
    Saline will be administered as two 30-min IV infusions separated by 30-min, using the same volume of infusion solution and rates of administration as in the intravenous oxytocin intervention.
    Other names:
    • Normal saline
  • Drug: Intranasal oxytocin
    Oxytocin will be self-administered at the time the first IV infusion begins as a single 0.1 mL spray (12 IU) in each nostril followed in 5 min by another spray in each nostril. The total dose of oxytocin is 48 IU.
    Other names:
    • Pitocin
  • Drug: Intranasal placebo
    Placebo (solution containing the excipients in the oxytocin solution but without oxytocin) will be self-administered at the time the first IV infusion begins as a single 0.1 mL spray in each nostril followed in 5 min by another spray in each nostril.
    Other names:
    • Excipients: chlorobutanol, methylparaben, propylparaben, dibasic sodium phosphate, anhydrous citric acid, sorbitol, glycerin, and sterile water

Recruiting Locations

Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina 27157
Contact:
Regina Curry, RN
336-716-4294
regina.curry@advocatehealth.org

More Details

Status
Recruiting
Sponsor
Wake Forest University Health Sciences

Study Contact

James C Eisenach, MD
336-716-4182
eisenach@wakehealth.edu

Detailed Description

This protocol will utilize a randomized, triple-masked, cross-over study design to compare intravenous (IV) to intranasal (IN) oxytocin administration for analgesia to an experimental pain stimulus in healthy volunteers. Equal numbers of adult men and women; ages 18-55 will be recruited. Participants will report to the research unit for three visits, 1) screening, informed consent, pregnancy test, and training to consistently rate pain from an FDA-approved device to test heat pain. The lowest temperature which causes a pain score of greater than 2 with 5 minutes of heating will be identified, 2) intravenous infusion and self-administered intranasal spray of study drug and 5-minute heat testing at intervals for 4 hours, 3) a repeat of the procedures done at visit two. Participants will receive intravenous oxytocin, 20 IU and intranasal placebo on one of these visits and intravenous placebo and intranasal oxytocin, 48 IU, on the other. Pain score at the end of 5-minute skin heating will be compared using mathematical modeling of the time course of change in each individual and in the study population as a whole. The effect, if any, on these models of participant age, sex, and weight will be explored.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.