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临床试验/NCT03215940
NCT03215940已完成早期 1 期

Treatment of Chronic Pain With Cannabidiol (CBD) and Delta-9-tetrahydrocannabinol (THC): Effectiveness, Side Effects and Neurobiological Changes

University of Utah1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2018年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
53
试验地点
1
主要终点
Brain Changes

研究概览

简要总结

This is a study comparing the effects of Delta-9-Tetrahydrocannabinol (THC) versus Cannabidiol (CBD) versus a placebo on chronic non-cancer pain.

详细描述

The overall aim of this study is to examine the effects of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) on chronic pain symptoms, specifically we will examine the effects of different doses of THC/CBD on symptoms of chronic pain and life functioning. Participants will include individuals with chronic pain, who will be randomized into one of three intervention conditions: high THC/low CBD, low THC/high CBD, or placebo. In addition to receiving THC/CBD/placebo, participants also will complete symptom assessments of chronic pain data (intensity, quality, interference/disability) throughout the study. These measures will be gathered prior to and following the fifth doses (dosing will occur once per day for five days) of CBD/THC or placebo. A secondary objective will be to examine the association between clinical and neurocognitive variables and use of CBD/THC, including the potential side effects of THC/CBD. Other secondary objectives include the use of magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS), acquired before and after final administration with CBD/THC or placebo to examine differences in brain metabolism, brain connectivity, and brain structure. Imaging analyses will focus on regional brain changes before and after administration of THC/CBD/placebo.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Delta-9-Tetrahydrocannabinol's (Delta-9-THC) effects on pain

Active Comparator

This arm will be testing the analgesic effects of orally dosed Delta-9-Tetrahydrocannabinol on subjects with chronic non-cancer pain.

干预措施: Delta-9-Tetrahydrocannabinol (Drug)

Cannabidiol's (CBD) effects on pain

Active Comparator

This arm will be testing the analgesic effects of orally dosed Cannabidiol on subjects with chronic non-cancer pain.

干预措施: Cannabidiol (Drug)

Placebo

Placebo Comparator

This Placebo arm will act as the control as standard of care medications will be continued through the study. This arm will allow us to compare the analgesic effects of the other two arms with the standard of care treatments for chronic non-cancer pain.

干预措施: Placebos (Drug)

结局指标

主要结局

Brain Changes

时间窗: 5 days

Participants will undergo MRI scanning designed to assess white matter microstructure and focal brain activation at the baseline visit (day 1) and visit five (day 5) in order to determine whether the administration of Delta-9-THC, CBD, or Placebo will result in changes to these brain indices in participants with chronic pain.

次要结局

  • Improvement in pain relief(7 days)

研究者

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

Deborah Yurgelun-Todd

Director of the Brain Institute

University of Utah

研究点 (1)

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