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: 10161211
• 负责人: MARIANA CHERNER
• 金额: $ 23.64万
• 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 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10161211
• 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.

总结 我们建议进行一项随机、双盲安慰剂对照试验，以收集初步数据， 大麻二酚（CBD）在管理艾滋病毒感染者（PLWH）的睡眠问题，并确定一种有效的 次给药结束睡眠问题在PLWH中非常常见，患病率比在PLWH中高出两到四倍。 一般人口。睡眠受损和目前的失眠治疗，通常是镇静/催眠 药物，可能会导致认知功能受损。这也可能导致健康状况较差 因为福尔斯摔倒和驾驶受损的风险增加。考虑到艾滋病毒和睡眠障碍的潜在相互作用， 实际的功能和生活质量，重要的是要开发治疗，最大限度地减少额外的 神经认知负担的人群已经容易受到脑功能障碍。生物多样性公约是 大麻植物，可能有许多有益的效果，并被认为是不损害认知。 临床研究表明，CBD可能会导致轻度镇静的副作用，轶事证据表明， PLWH以及其他人发现CBD对管理睡眠，焦虑和各种其他疾病有用。等 报告表明，CBD可以为PWLH提供睡眠益处，而没有显著的负面副作用 典型的治疗方法。然而，客观的科学证据的好处，或可能的有害影响， 缺乏。我们将使用腕戴式活动记录仪以及通过自我报告客观地测量睡眠结果。 睡眠日记和有效问卷。我们还将通过以下方式验证CBD是否没有“宿醉”效应： 在完成CBD治疗之前和第二天早上测量客观认知结果。积极 研究结果将提供数据支持更大的临床试验，以确定CBD的安全性和有效性， 这是一种潜在的镇静/催眠疗法，用于治疗艾滋病毒感染者的睡眠问题。