Efficacy of Spinal Oxytocin in Healthy Volunteers

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-02

Study Completion Date

2022-10-10

Brief Summary

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The purpose of this study is to determine the effect of intrathecal oxytocin on areas and intensity of hyperalgesia and allodynia induced by topical capsaicin.

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Detailed Description

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Purpose: There is a strong experimental basis to support the study of oxytocin by the spinal route for analgesia in humans. Oxytocin containing cells in the dorsal parvocellular division of the paraventricular nucleus (PVN) project to the spinal cord (1). Noxious stimulation activates these cells via the A1 noradrenergic relay in the pons (2) and produces analgesia by spinal release of oxytocin, since intrathecal injection of an oxytocin receptor antagonist worsens pain behaviors from peripheral inflammation (3). Direct electrical stimulation of the PVN reduces dorsal horn neuronal responses to noxious stimulation, and this is blocked by administration of sequestering antibody for oxytocin (4). Similarly, direct electrical stimulation of the PVN reduces behavioral sensitivity in a model of chronic neuropathic pain, and this effect is blocked by an oxytocin receptor antagonist (5). Intrathecal injection of oxytocin in normal rats reduces dorsal horn neuronal responses to noxious stimuli (6) as well as behavioral responses to noxious thermal (3), mechanical (3), and chemical (7) stimuli. Finally, intrathecal injection of oxytocin in rat models of chronic pain also reduces dorsal horn neuronal responses to sensory stimulation (6) as well as behavioral responses to thermal (5) and mechanical (7) stimuli.

Rationale: We anticipate that oxytocin will be effective after spinal injection in humans against chemical induced hypersensitivity states.

Objectives: Determine the effect of intrathecal oxytocin on areas and intensity of hyperalgesia and allodynia induced by topical capsaicin.

Conditions

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Healthy Volunteer Study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects are randomized into one of 3 groups to receive, in a double-blind manner, intrathecal saline or intrathecal oxytocin, 15 mcg or 150 mcg

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Randomization is prepared by a statistician not otherwise involved in the study or data analysis and is maintained by the Wake Forest University School of Medicine research pharmacy. Study drug is dispensed by the research pharmacy labelled as "Study drug containing normal saline or oxytocin 15 mcg in normal saline or oxytocin 150 mcg in normal saline" to indicate the possible contents of the solution, thereby maintaining blind.

Study Groups

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Oxytocin 15 mcg

Oxytocin 15 mcg injected spinally

Group Type EXPERIMENTAL

Oxytocin 15 mcg

Intervention Type DRUG

Oxytocin 15 mcg will be administered spinally

Oxytocin 150 mcg

Oxytocin 150 mcg injected spinally

Group Type EXPERIMENTAL

Oxytocin 150 mcg

Intervention Type DRUG

Oxytocin 150 mcg will be administered spinally

Placebo

Preservative free normal saline injected spinally

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

placebo will be administered spinally

Interventions

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Oxytocin 15 mcg

Oxytocin 15 mcg will be administered spinally

Intervention Type DRUG

Oxytocin 150 mcg

Oxytocin 150 mcg will be administered spinally

Intervention Type DRUG

Placebo

placebo will be administered spinally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy
* weight \< 240 pounds
* American Society of Anesthesiology Category 1 or 2

Exclusion Criteria

* allergy to oxytocin or lidocaine
* allergy to chilli peppers
* Females: active gynecological disease such as uterine fibroids or ongoing bleeding
* Pregnancy or currently breastfeeding
* Females that have delivered a baby within 2 years of study
* Taking prescription medications (exception: oral birth control medication)

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes