Use of CBD Oil for Reducing the Negative Emotional Impact of COVID-19: A Randomized Placebo-Controlled Clinical Trial
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
- 是
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
Michael J. Telch
Principal Investigator
University of Texas at Austin
