Cannabis for Palliative Care in Cancer: A Placebo-controlled Randomized Trial of Full Spectrum Hemp-derived CBD/THC

大麻用于癌症姑息治疗：全谱大麻衍生 CBD/THC 的安慰剂对照随机试验

• 批准号: 10754176
• 负责人: Angela Bryan
• 金额: $ 65.1万
• 依托单位: UNIVERSITY OF COLORADO
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10754176
• 关键词: Acute; Address; Age; American Cancer Society; Anxiety; Attenuated; Blood; Cancer Patient; Cancer Survivor; Cannabidiol; Cannabinoids; Cannabis; Chemicals; Cognitive deficits; Data; Diagnosis; Disease; Dose; Effectiveness; Encapsulated; Hemp; Hour; Impaired cognition; Individual; Legal; Literature; Long-Term Effects; Malignant Neoplasms; Marketing; Measures; Memory; Mental Depression; Mental Health; Moods; Outcome; Pain; Pain intensity; Pain interference; Palliative Care; Patients; Pharmaceutical Preparations; Pilot Projects; Placebo Control; Placebos; Plants; Polypharmacy; Prevalence; Prevention; Proliferating; Quality of life; Radiation; Randomized; Reporting; Research; Review Literature; Risk; Role; Scientist; Sleep; Sleep Disorders; Sleep disturbances; Standardization; Stress; Surveys; Symptoms; Task Performances; Testing; Tetrahydrocannabinol; United States; Variant; Work; active method; affective disturbance; cancer diagnosis; cancer therapy; chemobrain; chemotherapy; cognitive function; cognitive task; design; efficacy evaluation; experience; experimental study; improved; interest; marijuana use; multiple drug use; pain reduction; pilot trial; placebo group; prescription opioid; psychologic; psychological distress; randomized placebo controlled trial; reduce symptoms; side effect; sleep quality; synthetic cannabinoid; trend

Project Summary Problems with pain, sleep, and mood are common among individuals diagnosed with cancer (i.e., cancer survivors/patients), and many are turning to cannabis for symptom relief/palliative care. Recent reviews of the literature suggest that cannabis use can indeed provide benefit for symptoms including pain interference, pain intensity, and aspects of mood disturbance (i.e., anxiety). Cannabis may also prove less harmful/more beneficial than other palliative care options like opiate medications, and may reduce the use of multiple drugs (i.e., polypharmacy). Despite these promising benefits, it is also important to consider the potential negative effects cancer patients may experience from cannabis use, including compromised cognitive function. Research clearly demonstrates that cannabis compromises objective functioning immediately after use, but there is mixed evidence regarding its effects long-term. This equivocation may be due to cannabinoid content as the main psychoactive constituent of cannabis, ∆9-tetrahydrocannabinol (THC) is associated with memory and other cognitive impairment, but cannabidiol (CBD), a non-psychoactive cannabinoid, may attenuate these negative effects. Such effects are especially important to consider among cancer patients who are particularly vulnerable to cognitive deficits. Differential effectiveness of CBD versus THC versus a combination is also evident for outcomes of sleep disturbance, anxiety, and pain. Overall, as cannabis continues to become legally available across the US and cancer patients look to cannabis for relief, more studies are needed to better determine the efficacy of cannabis use, the role of different cannabinoid ratios, and what side effects may arise from its use. Existing research examines synthetic cannabinoids which are chemically homogenous and THC/CBD isolates which are unrepresentative of the whole-plant products that are now widely available in the United States. As such, it is increasingly necessary to conduct rigorous experimental research using more ecologically valid forms of cannabis among cancer patients. The present proposal seeks to utilize a rigorous placebo-controlled randomized trial to understand the effects of full spectrum hemp-derived CBD (fsCBD; CBD that contains a small amount of THC) and broad spectrum hemp- derived CBD (bsCBD; CBD that contains no THC) versus placebo on measures of sleep, pain, mood disturbance, subjective and objective cognitive functioning, and quality of life. These CBD products can be legally purchased and used over the counter across the U.S., so the results of this study have immediate application to and importance for cancer patients and their clinicians. The project aims are to 1) compare the effects of fsCBD vs bsCBD vs placebo on sleep quality, pain intensity/interference, mood disturbance (anxiety, depression), cognitive functioning, and quality of life over 8 weeks of sustained use and 2) compare the acute effects of fsCBD vs bsCBD vs placebo one and two hours after use on pain intensity, current mood, and objective cognitive task performance.

项目摘要 疼痛，睡眠和情绪问题在被诊断出患有癌症的个体中很常见（即癌症 幸存者/患者），许多人正在转向大麻以缓解症状/姑息治疗。最近评论 文献表明，大麻的使用确实可以为症状提供益处，包括疼痛干扰，疼痛 情绪障碍的强度和方面（即动画）。大麻也可能证明有害/更多 比其他姑息治疗方案（例如优化药物）有益，并可能减少多种 药物（即多药）。尽管有这些承诺的好处，但考虑潜力也很重要 负面影响癌症患者可能会因使用大麻而经历，包括认知功能受损。 研究清楚地表明，大麻在使用后立即损害了目标功能 但是关于其长期影响的证据不同。这种模棱两可可能是由于大麻素 内容作为大麻的主要精神活性组成部分，Δ9-四氢大麻酚（THC）是相关的 有记忆和其他认知障碍，但是大麻二酚（CBD）是一种非精神活性大麻素 减轻这些负面影响。这种影响对于在癌症患者中考虑 特别容易受到认知缺陷的影响。 CBD与THC与A的差异有效性 结合也证明了睡眠灾难，焦虑和痛苦的结果。总体而言，作为大麻 在整个美国的法律上继续使用，癌症患者希望大麻以缓解，更多 需要研究以更好地确定大麻使用的效率，不同大麻素比的作用， 它的使用可能会产生什么副作用。现有的研究考试合成大麻素 化学均匀和THC/CBD分离株，这些分离物是整个植物产物的代表性的 现在在美国广泛使用。因此，越来越有必要进行严格 在癌症患者中使用更有效的大麻形式的实验研究。现在 提案旨在利用严格的安慰剂对照随机试验来了解完整的影响 光谱大麻衍生的CBD（FSCBD； CBD包含少量THC）和宽光谱大麻 派生的CBD（BSCBD；不包含THC的CBD）与安慰剂有关睡眠，疼痛，情绪的措施 干扰，主观和客观的认知功能以及生活质量。这些CBD产品可以是 合法购买并在美国各地的柜台上使用，因此本研究的结果立即 对癌症患者及其临床医生的适用和重要性。该项目的目的是1）比较 FSCBD与BSCBD与安慰剂的影响对睡眠质量，疼痛强度/干扰，情绪障碍（焦虑， 抑郁症），认知功能和生活质量在8周的持续使用中； 2）比较急性 使用后，FSCBD与BSCBD与安慰剂的影响，使用后两个小时在疼痛强度，当前的情绪和 客观认知任务表现。