Pilot Trial of CBD for Sleep in People with HIV

CBD 对艾滋病毒感染者睡眠的试点试验

• 批准号: 10265582
• 负责人: MARIANA CHERNER
• 金额: $ 19.75万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-30 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10265582
• 关键词: Anxiety; Area; Cannabidiol; Cannabis; Child; Circadian Rhythms; Clinical; Clinical Research; Clinical Trials; Cognition; Cognitive; Cognitive deficits; Critiques; Data; Documentation; Dose; Double-Blind Method; Fatigue; General Population; HIV; Habits; Health; Human; Internet; Lead; Maintenance; Marijuana; Measures; Medicine; Neurocognition; Neurocognitive; Neurocognitive Deficit; Outcome; Participant; Patient Self-Report; Performance; Pharmaceutical Preparations; Pharmacological Treatment; Phase; Placebo Control; Placebos; Plants; Population; Prevalence; Publishing; Quality of life; Questionnaires; Randomized; Recommendation; Reporting; Review Literature; Risk; Safety; Sedation procedure; Seizures; Severities; Sleep; Sleep Disorders; Sleep disturbances; Sleeplessness; Symptoms; Testing; Tetrahydrocannabinol; Therapeutic; Time; Wrist; actigraphy; adverse outcome; brain dysfunction; circadian regulation; cognitive function; control trial; diaries; effectiveness trial; endogenous cannabinoid system; evidence base; exogenous cannabinoid; experience; fall risk; hangover; hypnotic; impaired driving performance; improved; innovation; pilot trial; pre-clinical; response; sedative; side effect; sleep quality

SUMMARY We propose pilot a randomized, double-blind placebo control trial to collect preliminary data examining the utility of Cannabidiol (CBD) in managing sleep problems in in people living with HIV (PLWH) and identify an efficacious dose. Sleep problems are very common among PLWH, with prevalence rates two-to-four-fold higher than in the general population. Both impaired sleep and current treatments for insomnia, typically sedative/hypnotic medications, can result in compromised cognitive functioning. This can lead to poorer health outcomes as well as elevated risks from falls and impaired driving. Given the potential interaction of HIV and disordered sleep on real-word functioning and quality of life, it is important to develop treatments that minimize additional neurocognitive burden in a population already vulnerable to brain dysfunction. CBD is a component of the marijuana plant that may have a number of beneficial effects and is understood to be non-impairing cognitively. Clinical studies indicate that CBD may result in mild sedation as a side effect, and anecdotal evidence suggests that PLWH, as well as others, find CBD useful for managing sleep, anxiety, and a variety of other ailments. Such reports suggest that CBD could provide sleep benefits for PWLH, without the significant negative side effects seen with typical treatments. However, objective scientific evidence of benefits, or possible detrimental effects, is lacking. We will measure sleep outcomes objectively using wrist-worn actigraphy as well as by self-report via sleep diaries and validated questionnaires. We will also verify whether CBD is free from “hangover” effects by measuring objective cognitive outcomes before and in next-morning after completion of CBD treatment. Positive study results will provide data in support of a larger clinical trial to determine the safety and efficacy of CBD as a potential sedative/hypnotic-sparing treatment for sleep problems in people living with HIV.

概括 我们提出了一项随机的双盲安慰剂控制试验，以收集检查实用程序的初步数据 大麻二酚（CBD）在管理艾滋病毒（PLWH）的患者的睡眠问题上 剂量。睡眠问题在PLWH中非常普遍，患病率比 一般人口。睡眠受损和失眠的当前治疗方法，通常为镇静/催眠 药物，可能导致认知功能受损。这也会导致健康状况较差 跌倒和驾驶受损的风险升高。鉴于艾滋病毒和无序睡眠的潜在相互作用 现实词的功能和生活质量，开发疗法以最大程度地减少额外 人群中的神经认知伯恩（Burnen）已经容易受到脑功能障碍的影响。 CBD是 大麻植物可能具有许多有益的作用，并且被理解为没有认知上的不受影响。 临床研究表明，CBD可能导致轻度镇静作用作为副作用，轶事证据表明 该PLWH以及其他人都发现CBD可用于管理睡眠，焦虑和其他各种疾病。 报告表明，CBD可以为PWLH提供睡眠益处，而没有明显的负面影响 看到典型的治疗方法。但是，客观的科学证据或可能的有害影响， 缺乏。我们将使用腕上磨损的动作术以及通过自我报告来客观地测量睡眠结果 睡眠日记和经过验证的问卷。我们还将验证CBD是否免受“宿醉”效果 在CBD治疗完成后和下一个过程中，测量客观认知结果。积极的 研究结果将提供支持更大临床试验的数据，以确定CBD的安全性和效率为 潜在的镇静/催眠治疗艾滋病毒患者的睡眠问题。