Cannabinoids and Traumatic Brain Injury: A Randomized, Placebo Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Change in Neuropsychiatric Symptoms
研究概览
简要总结
This is a double-blind, placebo-controlled, parallel group study designed to assess the tolerability and efficacy of fsCBD and bsCBD, compared to a placebo control, to improve cognition and traumatic brain injury-related symptoms. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.
详细描述
To better understand the effects of hemp-derived CBD with and without a small amount of THC, we propose a Phase II randomized clinical trial (RCT) to examine the safety, tolerability, and clinical effects of Full Spectrum CBD (fsCBD, contains less than 0.3% THC) vs. Broad Spectrum CBD (bsCBD, does not contain THC), vs. a matching placebo in a population of patients with traumatic brain injury.
This is a double-blind, placebo-controlled, parallel group study designed to assess the tolerability and efficacy of fsCBD and bsCBD, compared to a placebo control, to improve cognition and TBI-related symptoms such as anxiety, pain, depression, and sleep. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.
The initial Week 0 / Baseline visit will take place at the University of Colorado Anschutz Medical Campus. There will be in-person visits at Weeks 1, 6, and 12. Participants will be contacted remotely each remaining week during the 12-week period.
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)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide valid informed consent
- •18-60 years old
- •Current or history of TBI as identified by the Ohio Identification Method
- •TBI severity is mild or moderate based on the VA/DoD Classification of TBI Severity
- •TBI event must have resulted in hospital evaluation (emergency department or other hospital-based assessment) or evaluation within a clinical setting, except in cases in which the TBI was acquired in a military deployment context in which medical services were not immediately available
- •Ongoing neuropsychiatric symptoms (i.e., depressive, anxiety, pain, cognitive complaints, or sleep complaints) that are plausibly associated with TBI and not better accounted for by co-occurring medical or psychological health conditions
- •Not currently in another treatment study for TBI-related symptoms or co-occurring medical or psychological health conditions
- •Co-occurring treatments must be stable in type, dose, and frequency for the four weeks preceding study enrollment and participants must commit to making no changes in these co-occurring treatments during the study
排除标准
- •Currently incarcerated, paroled, or on probation
- •Participant has retained an attorney in relation to the TBI
- •Pregnant at the time of study enrollment or unwilling to commit to the use of two forms of contraception throughout the duration of the study
- •Vision, hearing, or communication impairments that preclude valid completion of study assessments
- •History of autism spectrum disorders, intellectual disability, and/or serious neurological or central nervous system disease that would be expected to affect cognition (e.g., epilepsy, tumors, multiple sclerosis)
- •Evidence of poor effort (TOMMe < 8) on neuropsychological testing at baseline/Week 0
- •Current or lifetime diagnosis of a schizophrenia spectrum disorder, psychotic disorder, bipolar disorder type I & II, cluster B personality disorders (antisocial, borderline, narcissistic, histrionic), eating disorders, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revised (DSM-5-TR, APA 2022)
- •Meets criteria for major depressive episode as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revised (DSM-5-TR, APA 2022) and with a Beck Depression Inventory-2 score > 24;
- •Current suicidal ideation, as indicated by Beck Depression Inventory-2 item #9 score > 0, or C-SSRS endorsement of item #2, or verbal or written report of current suicidal ideation by the participant to any study team member
- •History of significant systemic illness or unstable medical condition
- •Alcohol use disorder score of 5 or greater, or substance use disorder, based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revised (DSM-5-TR, APA 2022), in the six months preceding study enrollment
- •Reported use of other drugs (cocaine, opiates, methamphetamine, MDMA) in the past 60 days or test positive on a urine test for those drugs of abuse at baseline;
- •Currently taking medications known to be contraindicated with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide, clobazam, lamotrigine, valproate).
- •Current diagnosis of a seizure disorder or epilepsy
- •Report using cannabis once daily or more than once daily over the last 12 months
- •Report current use of CBD for medical reasons or TBI symptoms
- •Liver function enzymes (AST, ALT) that are greater than 2x normal
研究组 & 干预措施
Full Spectrum Cannabidiol
Full Spectrum Cannabidiol (<0.3% THC) Oral softgel capsule, 210mg/day
干预措施: Cannabidiol (Drug)
Broad Spectrum Cannabidiol
Broad Spectrum Cannabidiol (0.0% THC) Oral softgel capsule, 210mg/day
干预措施: Cannabidiol (Drug)
Hemp Seed Oil
Placebo Oral softgel capsule, 210mg/day
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Neuropsychiatric Symptoms
时间窗: Week 0 to Week 12
The effects of study treatment (CBD or placebo) on neuropsychiatric symptoms associated with TBI will be assessed by the Neurobehavioral Symptom Inventory (NSI)
Change in Cognition
时间窗: Week 0 to Week 12
The effects of study treatment (CBD or placebo) on attention, processing speed, working memory, long-term memory recall, and executive function will be assessed using the Trail Making Test; the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Digit Span, Symbol Search, Coding, Letter-Number Sequencing; and HVLT delayed recall, to create domain scores used to inform an aggregate measure of cognition.
次要结局
- Change in Biomarkers of Oxidative Stress(Week 0 to Week 12)
- Change in Pain Intensity(Week 0 to 12)
- Change in Biomarkers of Inflammation(Week 0 to Week 6, Week 0 to Week 12)
- Change in Anxiety(Week 0 to 12)
- Change in Sleep Disturbance(Week 0 to Week 6, Week 0 to Week 12)
- Change in Quality of Life(Week 0 to Week 12)
- Change in Depression(Week 0 to Week 12)