Enhancing Prolonged Exposure With Cannabidiol to Treat Posttraumatic Stress Disorder: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Clinician Administered PTSD Scale (CAPS-5)
研究概览
简要总结
The primary goal of this pilot project is to demonstrate the safety and feasibility of using Cannabidiol (CBD) in combination with standard of care prolonged exposure (PE) psychotherapy to reduce PTSD symptoms.
详细描述
This study is an early Phase II double-blind, pilot randomized controlled clinical trial. The study team will use a permuted block randomization design stratified by a Posttraumatic Stress Disorder (PTSD) severity median score on the PTSD Checklist (PCL-5) derived from a recently completed STRONG STAR repository. Participants will be up to 24 individuals with PTSD to investigate the safety, feasibility, and PTSD symptom change associated with CBD 250mg taken twice a day for 18 days (n=up to 12) vs. placebo (n=up to12) in combination with a standard of care, 10-sessions massed PE psychotherapy administered over 2 weeks. Aims 2 and 3 will evaluate biochemical and physiological outcomes associated with the brain endocannabinoid (eCB) and PTSD that may be affected by CBD. Permuted block randomization is advantageous in small clinical trials to ensure equal allocation of participants in each condition. Participant randomization will be subdivided into randomized blocks of four, two patients in each block will be assigned to CBD and two will be assigned to 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)
盲法说明
A compounding pharmacy will supply both the study drug and a matching strawberry flavored liquid.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals between the age of 18 to 65 years old at time of screening.
- •Able to write, read, and speak English
- •PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5)
- •Stable medication regimen for at least four weeks prior to the onset of study participation.
排除标准
- •History of opiate, cocaine, methamphetamine, benzodiazepine, or cannabis abuse as determined by the National Institute of Drug Abuse Quick Screen (NIDA-Q).
- •Currently using opiates, cocaine, methamphetamines, benzodiazepines, or cannabis as evidenced by a positive urine drug screen prior to enrollment.
- •Currently pregnant as determined by a positive urine pregnancy test prior to enrollment.
- •Current clinically significant alcohol abuse in the past two weeks on the Quick Drinking Screen (QDS).
- •Currently breastfeeding.
- •Ongoing illness or physical health problem(s) that may be exacerbated by CBD (e.g., history of liver problems)
- •History of significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to cannabinoids.
- •Concomitant medications with possible CBD-drug interactions
- •Alanine transaminase (ALT) or Aspartate transaminase (AST) enzyme levels 3x normal limits.
- •Concurrent engagement in trauma-related psychotherapy for PTSD.
- •Current or past DSM-5 diagnosis of psychotic disorder or bipolar disorder as determined on the Mini International Neuropsychiatric Interview (MINI 7.0).
- •Suicide attempt in the last year and/or suicide risk requiring immediate intervention or requiring a higher level of care than can be provided by the study treatment as determined by the Self-Injurious Thoughts and Behaviors Interview (SIT-BI).
- •Allergy to sesame seed oil.
研究组 & 干预措施
Cannabidiol (CBD)
Epidiolex oral solution 500mg (5ml) per day
干预措施: Cannabidiol (CBD) oral solution (Drug)
Cannabidiol (CBD)
Epidiolex oral solution 500mg (5ml) per day
干预措施: Massed Prolonged Exposure (mPE) (Behavioral)
Placebo
Placebo oral solution 5ml per day
干预措施: Placebo (Drug)
Placebo
Placebo oral solution 5ml per day
干预措施: Massed Prolonged Exposure (mPE) (Behavioral)
结局指标
主要结局
Clinician Administered PTSD Scale (CAPS-5)
时间窗: Baseline and at about 45 days (1 month follow-up visit)
The CAPS-5 is structured interview that assesses the Diagnostic and Statistical Manual of Mental Disorders v5 (DSM-5) criteria for PTSD. Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms.Subscale scores are calculated by summing severity scores for items in the following PTSD symptom clusters: re-experiencing, avoidance, negative alterations in cognitions and mood, and hyperarousal. Scores ≥ 25 indicate a probable diagnosis of PTSD. Scores range from 0 to 80. Change in score will be reported.
Posttraumatic Stress Disorder Checklist (PCL-5)
时间窗: Baseline and at about 45 days (1 month follow-up visit)
The PCL-5 is a 20-item self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5. The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past two weeks (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely). Scores range from 0 to 80 with a higher score indicating that subjects have been bothered more by PTSD symptoms. Change in score will be reported.
次要结局
- Patient Health Questionnaire-9 (PHQ-9)(Baseline and at about 45 Days (1 month follow-up visit))
研究者
Casey Straud
Assistant Professor
The University of Texas Health Science Center at San Antonio