Pilot Trial of CBD for Sleep in People with HIV

摘要 我们建议试点一项随机、双盲的安慰剂对照试验，以收集检验该效用的初步数据。 大麻二醇(CBD)在管理HIV感染者(PLWH)睡眠问题中的作用并确定有效的 剂量。睡眠问题在PLWH中非常普遍，患病率是中国的两到四倍 普通人口。睡眠受损和目前对失眠的治疗，通常是镇静/催眠 药物会导致认知功能受损。这也可能导致较差的健康结果。 因为跌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 真正的功能和生活质量，重要的是开发治疗方法，最大限度地减少额外的 在一个已经容易受到大脑功能障碍影响的人群中，神经认知负担。CBD是 大麻植物可能有一些有益的影响，并且被理解为对认知没有损害。 临床研究表明，CBD可能会导致轻微的镇静副作用，而坊间证据表明 PLWH和其他人发现CBD对控制睡眠、焦虑和其他各种疾病很有用。是这样的 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 在典型的治疗中可以看到。然而，客观的科学证据表明有益的，或可能有害的影响， 是缺乏的。我们将使用手腕佩戴的运动记录仪以及通过以下方式自我报告来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CBD治疗结束前和次日早晨测量客观认知结果。正性 研究结果将为更大规模的临床试验提供数据，以确定CBD的安全性和有效性 一种潜在的镇静/催眠疗法，用于治疗艾滋病毒携带者的睡眠问题。

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.