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临床试验/NCT01988649
NCT01988649撤回不适用

The Effect of Intranasal Oxytocin on Pain Sensitivity and Threshold: A Randomized, Double Blinded, Crossover Volunteer Study

Northwestern University1 个研究点 分布在 1 个国家开始时间: 2015年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Pain sensitivity and threshold

研究概览

简要总结

Oxytocin is neurohypophysial peptide that acts mainly as a neuromodulator in the brain. In addition,oxytocin have an important roles in sexual reproduction , in particular during and after childbirth. It facilitates birth, maternal bonding, and, breastfeeding. Nasal oxytocin has been commonly used to improve breastfeeding in lactating women. A review of safety , side effects and subjective reaction to intranasal oxytocin in human research in 1529 subjects did not review any differences from placebo. The vast majority of basic science studies suggested a large effect of oxytocin in minimizing acute pain.4 Few studies have demonstrated an association between plasma levels of oxytocin and pain in humans. No studies have examined the effect of intranasal oxytocin on pain sensitivity and threshold. Since addictive properties of oxytocin have not been described, the drug may have important application in the management of acute and chronic pain.

The main objective of the current investigation was to evaluate the effect of intranasal oxytocin on pain sensitivity and threshold in human volunteers. We hypothesized that intranasal oxytocin, in human volunteers ,would decrease sensitivity and and increase pain threshold compared to intranasal saline .

Significance: Intranasal oxytocin may become a viable treatment for acute and chronic pain in humans.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy males and females volunteers
  • English speaking
  • Age <20 and > 35

排除标准

  • Pregnancy
  • Lactation
  • Allergy to preservatives
  • Mental disease
  • Chronic pain
  • Current use of analgesics
  • Anxiety or depression Drop Out: volunteer request

研究组 & 干预措施

Intranasal Oxytocin

Active Comparator

Administration of 32 units of Oxytocin administered intranasally

干预措施: Intranasal Oxytocin (Drug)

Placebo (saline)

Placebo Comparator

Administration of 4 sprays intranasally of normal saline.

干预措施: Placebo (saline) (Drug)

结局指标

主要结局

Pain sensitivity and threshold

时间窗: 120 minutes

Pain sensitivity and threshold using the MEDoc device. Mechanical and thermal pain test will be performed at baseline, before drug administration, at 45 minutes and at 90 minutes.

次要结局

  • Side effects of Oxytocin(2 Hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Walega

Principal Investigator

Northwestern University

研究点 (1)

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