跳至主要内容
临床试验/NCT04603781
NCT04603781暂停2 期

Use of CBD Oil for Reducing the Negative Emotional Impact of COVID-19: A Randomized Placebo-Controlled Clinical Trial

University of Texas at Austin2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年12月4日最近更新:
适应症

试验速览

阶段
2 期
状态
暂停
入组人数
200
试验地点
2
主要终点
PROMIS Emotional Distress Index

研究概览

简要总结

Our purpose is to conduct a 4-arm placebo-controlled clinical trial to investigate the relative clinical efficacy of 300 mg. of pure hemp-derived CBD isolate, 300 mg. of full spectrum CBD oil, 300 mg. of broad- spectrum CBD Oil, or Placebo oil among adults presenting with COVID-19 -induced stress reactions including one or more of the following: anxiety, depression, anger, substance use, or sleep disturbance.

详细描述

Background and Significance of the Proposed Project

The COVID-19 pandemic has hit us like a ton of bricks creating unimaginable levels of unanticipated death, financial hardship, and dramatic changes in nearly every facet of our life including school, work, shopping, social and family life. Sadly, the physical, mental, economic, and health burden of COVID-19 disproportionately affects the poor, the elderly, and people of color.

The stress induced by these changes as well as the lack of control we have over them increases risk for new onset of mental health problems such as anxiety, depression, substance abuse, sleep disturbance, and family violence as well as exacerbation of symptoms among those with pre-existing psychiatric conditions. Although many people will successfully manage the increased stress from COVID-19 on their own or with the support from family and friends, others may need extra help to cope. Consequently, there is an urgent need for developing cost-effective strategies for managing the stress-induced psychological consequences of COVID-19.

There's been considerable excitement in the press over the potential therapeutic use of cannabidiol (CBD) products in the treatment of a variety of physical and mental health problems. Delta-9-tetrahydrocannabinol (delta-9 THC) is still illegal in most states because of its psychoactive abuse potential. In contrast, cannabidiol (CBD) does not convert to THC in the body and has negligible side effects relative to main-stream psychiatric drugs (benzodiazepines and antidepressants) commonly prescribed for the treatment of stress-related disorders such as anxiety, depression, and insomnia. Mounting evidence from studies with rodents suggests that CBD may confer significant promising health-related benefits including anti-inflammatory, pain-relieving, anti-cancer, memory enhancement, and facilitation of fear extinction (see White for a recent review).

The biggest success story for CBD use in humans to date comes from placebo-controlled randomized clinical trials demonstrating a 50% or more reduction in previously intractable seizures in children suffering from Dravet syndrome and Lennox-Gastaut syndrome. Moreover, several controlled clinical trials have shown promising findings in reducing psychotic symptoms among patients with schizophrenia and among young adults displaying THC-induced psychosis.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The PI and all members of the study team will be blind to the drug assignment of the patient. Only the CBD suppliers (John Fornecker- Way West and Anthony Ferrari - SunMed CBD) and a UT LSAD staff member (not connected to the study) will have access to participants' treatment assignment. In the very unlikely event that a participant should have an adverse reaction requiring medical attention, the PI will contact the UT staff person who is keeper of the blind and request the treatment assignment of the subject in question without revealing the treatment condition coding scheme.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older 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

结局指标

主要结局

PROMIS Emotional Distress Index

时间窗: Week 5-Follow-up

This measure is a 43-item patient-rated emotional distress symptom scale consisting of 6 sub-factors (Depression, Anxiety, Anger, Alcohol Use, Substance Use, and Sleep Disturbance). Each symptom is rated over a 7-day period on a 5-point scale.

次要结局

  • PROMIS Alcohol Negative Consequences Scale(Week 5- Follow-up)
  • PROMIS Anger Scale(Week 5- Follow-up)
  • Sheehan Disability Scale(Week 5- Follow-up)
  • PROMIS Depression Scale(Week 5-Follow-up)
  • PROMIS Anxiety Scale(Week 5-Follow-up)
  • PROMIS Sleep Disturbance Scale(Week 5- Follow-up)
  • COVID-19 Coping Self-Efficacy(Week 5- Follow-up)

研究者

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

Michael J. Telch

Principal Investigator

University of Texas at Austin

研究点 (2)

Loading locations...

相似试验