Use of Cannabidiol (CBD) Oil in the Treatment of PTSD: A Placebo-Controlled Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- PCL-5
研究概览
简要总结
The overarching objective of the proposed project is to test the clinical efficacy of CBD in the treatment of post-traumatic stress disorder using a rigorous double-blind randomized clinical trial methodology. Participants (n=150) meeting full DSM-5 criteria for post-traumatic stress disorder (PTSD) will be randomized to one of 3 treatment arms: (a) CBD -Isolate; (b) CBD-Broad Spectrum; (c) Placebo oil.
We predict that patients receiving CBD isolate or CBD Broad Spectrum will show significantly greater improvements in PTSD symptoms and functional impairment at the posttreatment and one-month follow-up relative to patients receiving placebo oil. Additionally, we expect that patients receiving CBD Broad Spectrum will show significantly greater improvements relative to patients receiving CBD Isolate.
详细描述
Background and Significance of the Proposed Project
Over 80% of Americans are exposed to a significant trauma sometime during their lifetime and approximately 7% will meet for a threshold diagnosis of posttraumatic stress disorder. PTSD is the most costly anxiety-related disorder and confers significant interference in work, social functioning, increased risk for other physical and mental health problems, and a four-fold increase in suicide rates compared to the general population.
Over the past two decades, trauma-focused psychotherapies for PTSD have been shown to outperform more traditional supportive psychotherapy or pharmacotherapy and have become the first line treatment for PTSD. Despite these advances, trauma focused treatments such as prolonged exposure therapy (PE) are associated with high rates of treatment refusal, and among those who do enter treatment, approximately 25% drop-out. These data highlight the need to develop PTSD treatment strategies that are both effective and more palatable to patients.
More recently, 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 PTSD. 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 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
Each nightly dose of CBD/Placebo oil will be tagged with a code # on the plastic syringe containing the CBD oil or placebo oil. All oils will have identical color and mint flavor. Two independent staff not connected to the study will be unblinded to the participants' assignment to condition.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets for a current DSM-5 diagnosis of PTSD as their "primary" mental disorder
- •Age 18 or older
- •Fluent in English
- •Has access to the internet
- •Willingness to provide signed informed consent
- •Willingness to refrain from all non-study cannabis use during the study period
排除标准
- •History of a suicide attempt within the past 6 months
- •History of psychosis within the past 6 months
- •History of current alcohol or substance use disorder within the past month
- •Any medical problems that would preclude participating in the study
- •History of adverse reaction to CBD oil or other CBD products
- •Allergy to coconut oil
研究组 & 干预措施
CBD Isolate
300 mg/day of CBD isolate
干预措施: CBD Isolate (Drug)
CBD Broad Spectrum
300 mg/day of CBD Broad Spectrum Oil
干预措施: CBD Broad Spectrum (Other)
Placebo oil
Matched Placebo Oil
干预措施: Placebo oil (Other)
结局指标
主要结局
PCL-5
时间窗: Post-treatment (week 9) and one month (week 13) follow-up assessments
Change from baseline in patient-rated symptoms of PTSD.
次要结局
- GAD-7(Post-treatment (week 9) and one month (week 13) follow-up assessments)
- PROMIS Alcohol Use -Short Form(Post-treatment (week 9) and one month (week 13) follow-up assessments)
- PHQ-9(Post-treatment (week 9) and one month (week 13) follow-up assessments)
- SDS(Post-treatment (week 9) and one month (week 13) follow-up assessments)
- WHOQOL-BREF(Post-treatment (week 9) and one month (week 13) follow-up assessments)
研究者
Michael J. Telch
Professor of Psychology
University of Texas at Austin