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.

项目概要 疼痛、睡眠和情绪问题在被诊断患有癌症（即癌症）的个体中很常见。 幸存者/患者），许多人正在转向大麻来缓解症状/姑息治疗。 文献表明，使用大麻确实可以缓解疼痛症状，包括疼痛干扰、疼痛 大麻的强度和情绪障碍（即焦虑）的危害也可能较小/更大。 比阿片类药物等其他姑息治疗选择有益，并且可以减少多种药物的使用 尽管有这些有希望的好处，但考虑其潜力也很重要。 癌症患者可能因使用大麻而遭受负面影响，包括认知功能受损。 研究清楚地表明，大麻在使用后会立即损害客观功能， 但关于其长期影响的证据不一，这种模棱两可的情况可能是由于大麻素造成的。 作为大麻主要精神活性成分，Δ9-四氢大麻酚（THC）的含量与 具有记忆和其他认知障碍，但大麻二酚（CBD），一种非精神活性大麻素，可能 减轻这些负面影响对于癌症患者来说尤其重要。 特别容易受到 CBD 与 THC 与 A 的认知缺陷的影响。 总的来说，与大麻一样，这种组合对睡眠障碍、焦虑和疼痛的影响也很明显。 大麻在美国继续合法化，癌症患者寻求大麻来缓解疼痛，更多 需要进行研究以更好地确定大麻使用的功效、不同大麻素比例的作用、 现有的研究检查了合成大麻素的使用可能会产生哪些副作用。 化学同质和 THC/CBD 分离物不能代表全植物产品 现在在美国广泛使用，因此越来越有必要进行严格的处理。 在癌症患者中使用更生态有效的大麻形式进行实验研究。 该提案旨在利用严格的安慰剂对照随机试验来了解全面治疗的效果 光谱大麻衍生的 CBD（fsCBD；含有少量 THC 的 CBD）和广谱大麻 衍生 CBD（bsCBD；不含 THC 的 CBD）安慰剂与睡眠、疼痛、情绪测量的比较 这些 CBD 产品可以改善主观和客观认知功能以及生活质量。 在美国各地可以在柜台合法购买和使用，因此这项研究的结果可以立即得到 该项目的目的是 1) 比较癌症患者及其婴儿的应用和重要性。 fsCBD 与 bsCBD 与安慰剂对睡眠质量、疼痛强度/干扰、情绪障碍（焦虑、 抑郁）、认知功能和持续使用 8 周以上的生活质量，2）比较急性 使用 fsCBD 与 bsCBD 与安慰剂一小时和两小时后对疼痛强度、当前情绪和症状的影响 客观的认知任务表现。