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Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status and phase

Terminated
Phase 2

Conditions

Neuropathic Pain

Treatments

Drug: Normal Saline (preservative free)
Drug: oxytocin 100 micrograms

Study type

Interventional

Funder types

Other

Identifiers

NCT02100956
IRB00027272

Details and patient eligibility

About

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.

Full description

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.

Enrollment

8 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

8 participants in 2 patient groups

Oxytocin, then Placebo
Experimental group
Description:
The subject first received oxytocin 100 micrograms administered intrathecally (IT). After at least one week, they received normal saline placebo IT.
Treatment:
Drug: Normal Saline (preservative free)
Drug: oxytocin 100 micrograms
Placebo, then Oxytocin
Experimental group
Description:
The subject first received normal saline placebo intrathecally (IT). After at least one week, they then received oxytocin 100 micrograms administered IT.
Treatment:
Drug: Normal Saline (preservative free)
Drug: oxytocin 100 micrograms

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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