Pilot Trial of CBD for Sleep in People with HIV

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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.