A Randomized, Double-blind, Clinical Trial of a Hemp-Derived, High Cannabidiol Product for Anxiety in Glioblastoma Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change From Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)
研究概览
简要总结
Glioblastoma (GBM) is the most common malignant brain tumor among adults. As the diagnosis is generally considered terminal, patients with GBM often suffer from anxiety and other comorbid conditions, including depression, pain, and sleep disturbance, all of which significantly impact their quality of life. Previous studies have demonstrated the potential of cannabinoids, particularly cannabidiol (CBD), to improve the aforementioned symptoms without conferring significant risks or side effects. Further, recent in-vitro and in-vivo work suggests potential cytotoxic and anti-tumor effects of CBD and other cannabinoids.
This study includes a double-blind, placebo-controlled, 8-week randomized clinical trial assessing the impact of a custom formulated, full-spectrum, hemp-derived ultra-high CBD product on measures of anxiety, pain, and quality of life in newly-diagnosed GBM patients undergoing standard of care (SOC) treatment; the impact of this product vs. placebo on tumor progression will also be assessed. The proposed clinical trial will provide important information that does not currently exist regarding the potential efficacy of a novel full-spectrum, ultra-high CBD product to address clinical symptoms in patients with GBM.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documentation of newly diagnosed glioblastoma, evidenced by neuropathology report and based on World Health Organization (WHO) 2021 classification, and who are to undergo SOC (~ 6 weeks of treatment) with radiation and temozolomide (patients using Optune may be included).
- •Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
- •Fluent in English.
- •Endorses at least moderate levels of anxiety (on the BAI or OASIS) at the screening visit
- •Stable medication/psychotherapy regimens for at least 1 month prior to starting the study (excluding new glioblastoma treatment-related medications or radiation).
- •Karnofsky Performance Scale (KPS) of 60 or higher.
排除标准
- •Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- •Presence of a condition or abnormality that in the opinion of the Investigators would compromise the safety of the patient or the quality of the data.
- •Current substance use disorder, psychotic disorder, bipolar disorder, or eating disorder.
- •Current use of recreational cannabis, medical cannabis, or hemp-derived cannabinoid products more frequently than 1x/month; positive urine delta-9 tetrahydrocannabinol (THC) test.
- •Presence of a serious or unstable medical illness, including liver, kidney, or cardiovascular disease.
- •Current use of valproate (due to potential for drug-drug interactions).
- •Currently enrolled in other research studies or clinical trials involving therapeutic interventions.
- •Subjects with serum transaminase (ALT, AST, and total bilirubin) levels >3 times upper limit of normal (UNL) <24 hours prior to day 1 of treatment.
- •Contraindication to MRI such as non-MR conditional medical devices or ferrous retained foreign bodies.
研究组 & 干预措施
Placebo
Placebo solution administered for 8 weeks along with standard of care treatment
干预措施: Placebo (Drug)
Cannabidiol (CBD) Solution Plus Standard of Care (SOC)
Full-spectrum, hemp-derived, ultra-high CBD solution administered for 8 weeks along with standard of care treatment
干预措施: Cannabidiol (CBD) (Drug)
结局指标
主要结局
Change From Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)
时间窗: 8 weeks
The BAI is a 21-item self-report measure used to rate subjective, somatic, and panic-related symptoms of anxiety on a scale of 0 to 3 (higher scores indicating more anxiety). The full score range is 0-63.
Change From Baseline in Anxiety Assessed by the Overall Anxiety Severity and Impairment Scale (OASIS)
时间窗: 8 weeks
The OASIS is a brief 5-item measure used to evaluate the functional impairment cause by anxiety; the frequency and intensity of anxiety, as well as the degree of avoidance and interference with work and social function are rated on a scale of 0 to 4. Total scores range from 0-20 (higher scores indicating more anxiety).
次要结局
- Change From Baseline in Pain Assessed by the Pain Distress Scale (PDS)(8 weeks)
- Change From Baseline in Pain Assessed by the Pain Disability Index (PDI)(8 weeks)
- Change From Baseline in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)(8 weeks)
- Patient's Global Impression of Change (PGIC) at Follow-Up(8 weeks)
研究者
Staci Gruber, Ph.D.
Director, Marijuana Investigations for Neuroscientific Discovery; Director, Cognitive and Clinical Neuroimaging Core
Mclean Hospital