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

基本信息

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
项目类别：
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

项目摘要

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、双盲安慰剂对照试验，以收集检验效用的初步数据大麻二酚 (CBD) 在管理艾滋病毒感染者 (PLWH) 睡眠问题方面的作用，并确定了一种有效的方法睡眠问题在 PLWH 中非常常见，患病率比普通人群高两到四倍。普通人群的睡眠障碍和目前的失眠治疗方法，通常是镇静/催眠。药物可能会导致认知功能受损，这也会导致健康状况恶化。考虑到艾滋病毒和睡眠障碍之间的潜在相互作用，跌倒和驾驶障碍的风险会增加。实际功能和生活质量，重要的是开发能够最大限度地减少额外负担的治疗方法已经容易受到脑功能障碍影响的人群的神经认知负担是 CBD 的一个组成部分。大麻植物可能具有许多有益作用，并且被认为不会损害认知。临床研究表明 CBD 可能会导致轻度镇静副作用，而轶事证据表明 PLWH 以及其他人发现 CBD 对于控制睡眠、焦虑和各种其他疾病很有用。报告表明 CBD 可以为 PWLH 提供睡眠益处，且没有明显的负面副作用然而，客观的科学证据表明其益处或可能的疼痛效果，我们将使用腕戴式体动记录仪以及通过自我报告来客观地测量睡眠结果。我们还将通过睡眠日记和经过验证的问卷来验证 CBD 是否不受“宿醉”影响。在完成 CBD 治疗之前和第二天早上测量客观认知结果。研究结果将为更大规模的临床试验提供数据支持，以确定 CBD 的安全性和有效性一种针对艾滋病毒感染者睡眠问题的潜在镇静/催眠疗法。