Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-19

Study Completion Date

2022-10-10

Brief Summary

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The purpose of the study is to determine the effect of oxytocin given into the spinal fluid on pain and areas and intensity of hyperalgesia and allodynia in patients with chronic neuropathic pain.

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Detailed Description

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Rationale: The investigators anticipate that oxytocin will be effective after spinal injection in humans to acutely relieve chronic neuropathic pain.

Objectives: Determine the effect of intrathecal oxytocin on pain and areas and intensity of hyperalgesia and allodynia in patients with chronic neuropathic pain.

Interventions: A computer generated randomization will be used to determine the group for each subject. Subjects will be randomized to receive an intrathecal injection of saline (placebo) or oxytocin.

Conditions

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Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Oxytocin, then Placebo

The subject first received oxytocin 100 micrograms administered intrathecally (IT). After at least one week, they received normal saline placebo IT.

Group Type EXPERIMENTAL

oxytocin 100 micrograms

Intervention Type DRUG

oxytocin 100 micrograms administered intrathecally (IT)

Normal Saline (preservative free)

Intervention Type DRUG

Normal Saline (preservative free) administered intrathecally (IT)

Placebo, then Oxytocin

The subject first received normal saline placebo intrathecally (IT). After at least one week, they then received oxytocin 100 micrograms administered IT.

Group Type EXPERIMENTAL

oxytocin 100 micrograms

Intervention Type DRUG

oxytocin 100 micrograms administered intrathecally (IT)

Normal Saline (preservative free)

Intervention Type DRUG

Normal Saline (preservative free) administered intrathecally (IT)

Interventions

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oxytocin 100 micrograms

oxytocin 100 micrograms administered intrathecally (IT)

Intervention Type DRUG

Normal Saline (preservative free)

Normal Saline (preservative free) administered intrathecally (IT)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Weight \< or equal to 240 pounds
* Neuropathic pain for \> 6 months: with primary pain area below the umbilicus

Exclusion Criteria

* Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug or lidocaine
* 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
* Pregnancy
* spinal cord stimulators, chronic intrathecal drug therapy, or oral opioid treatment for \> 3 months at a current dose of \> 100 milligram (mg) morphine per day or equivalent.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No