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

项目摘要 疼痛、睡眠和情绪问题在被诊断患有癌症的个体中很常见（即，癌 幸存者/患者），许多人转向大麻以缓解症状/姑息治疗。最近的审查 文献表明，大麻使用确实可以为包括疼痛干扰、疼痛 强度和情绪障碍的方面（即，焦虑）。大麻也可能证明危害较小/更多 比其他姑息治疗方案，如阿片类药物，并可能减少使用多种 药物（即，多药疗法）。尽管有这些有希望的好处，但考虑到潜在的 癌症患者可能因使用大麻而受到的负面影响，包括认知功能受损。 研究清楚地表明，大麻在使用后立即损害客观功能， 但关于其长期影响的证据好坏参半。这种模棱两可可能是由于大麻素 作为大麻的主要精神活性成分，1，9-四氢大麻酚（THC）与 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， 减少这些负面影响。这些影响在癌症患者中尤其重要， 特别容易受到认知缺陷的影响。CBD与THC的不同有效性 组合对于睡眠障碍、焦虑和疼痛的结果也很明显。总的来说，大麻 大麻在美国各地继续合法使用，癌症患者寻求大麻缓解， 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， 以及它的使用可能产生什么副作用。现有的研究考察了合成大麻素， 化学上均质的THC/CBD分离物，其不代表全植物产品， 现在在美国广泛使用。因此，越来越有必要进行严格的 在癌症患者中使用更生态有效形式的大麻的实验研究。本 一项提案试图利用严格的安慰剂对照随机试验来了解充分 光谱大麻衍生的CBD（fsCBD;含有少量THC的CBD）和广谱大麻- 衍生的CBD（bsCBD;不含THC的CBD）与安慰剂在睡眠，疼痛，情绪 障碍、主观和客观认知功能以及生活质量。这些CBD产品可以 在美国各地合法购买和使用，所以这项研究的结果 对于癌症患者及其临床医生的应用和重要性。该项目的目标是：1）比较 fsCBD相对于bsCBD相对于安慰剂对睡眠质量、疼痛强度/干扰、情绪障碍（焦虑， 抑郁症），认知功能和生活质量超过8周的持续使用和2）比较急性 使用后1小时和2小时，fsCBD与bsCBD与安慰剂对疼痛强度、当前情绪和 客观认知任务绩效

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.