Effects of Intramuscular (IM) Oxytocin on Pupil Diameter and Heart Rate Variability (HRV)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-24

Study Completion Date

2021-11-01

Brief Summary

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The goal of this study is to test the effects of oxytocin on heart rate variability and pupil diameter, both of which have subtle effects on the activity rate of the autonomic nervous system.

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Detailed Description

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This protocol focuses on two measures of autonomic control to quantify central actions of oxytocin. First, the study team proposes to examine the influence of oxytocin on heart rate variability with focus on its effect on high frequency variability, most commonly ascribed to parasympathetic nervous system activity acting to brake sympathetic tone. Intranasal oxytocin has been demonstrated to have a large effect size on this measure which can be repeated at frequent intervals. As a secondary assessment of parasympathetic activity, the study team will measure low frequency fluctuation in pupil diameter, termed hippus, which also reflects parasympathetic nervous system activity. This outcome measure can be assessed in 3 seconds using equipment currently being used under Institutional Review Board (IRB) approved protocols.

Conditions

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Chronic Pain Due to Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Double blinded crossover treatment with oxytocin and placebo (saline)

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Participant, Investigator, and outcomes assessor will be blinded. The Research Pharmacist will prepare the study medication and hold the randomization.

Study Groups

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Oxytocin First, then Placebo

Subjects in this arm will receive Intramuscular injection of Oxytocin (Pitocin®), 10 International Units (IU) at the first visit. Then at the next visit, they will receive Intramuscular injection of (1 milliliter) saline.

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

Oxytocin 10 IU

Placebo

Intervention Type DRUG

Placebo

Placebo, Then Oxytocin

Subjects in this arm will receive intramuscular injection of (1 milliliter) saline at the first visit. Then at the next visit, they will receive Intramuscular injection of Oxytocin (Pitocin®), 10 International Units (IU).

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

Oxytocin 10 IU

Placebo

Intervention Type DRUG

Placebo

Interventions

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Oxytocin

Oxytocin 10 IU

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Pitocin saline

Eligibility Criteria

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Inclusion Criteria

* Male or female \> 18 and \< 66 years of age,
* Body Mass Index (BMI) \<40
* Generally in good health as determined by the Principal Investigator based on prior medical history
* Normal blood pressure and resting heart rate without medication

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
* 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.
* Neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
* Previous eye surgery, eye medications, cataracts

Minimum Eligible Age

18 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes