Cannabis for Palliative Care in Cancer: A Placebo-controlled Randomized Trial of Full Spectrum Hemp-derived CBD/THC

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Project Summary Problems with pain, sleep, and mood are common among individuals diagnosed with cancer (i.e., cancer survivors/patients), and many are turning to cannabis for symptom relief/palliative care. Recent reviews of the literature suggest that cannabis use can indeed provide benefit for symptoms including pain interference, pain intensity, and aspects of mood disturbance (i.e., anxiety). Cannabis may also prove less harmful/more beneficial than other palliative care options like opiate medications, and may reduce the use of multiple drugs (i.e., polypharmacy). Despite these promising benefits, it is also important to consider the potential negative effects cancer patients may experience from cannabis use, including compromised cognitive function. Research clearly demonstrates that cannabis compromises objective functioning immediately after use, but there is mixed evidence regarding its effects long-term. This equivocation may be due to cannabinoid content as the main psychoactive constituent of cannabis, ∆9-tetrahydrocannabinol (THC) is associated with memory and other cognitive impairment, but cannabidiol (CBD), a non-psychoactive cannabinoid, may attenuate these negative effects. Such effects are especially important to consider among cancer patients who are particularly vulnerable to cognitive deficits. Differential effectiveness of CBD versus THC versus a combination is also evident for outcomes of sleep disturbance, anxiety, and pain. Overall, as cannabis continues to become legally available across the US and cancer patients look to cannabis for relief, more studies are needed to better determine the efficacy of cannabis use, the role of different cannabinoid ratios, and what side effects may arise from its use. Existing research examines synthetic cannabinoids which are chemically homogenous and THC/CBD isolates which are unrepresentative of the whole-plant products that are now widely available in the United States. As such, it is increasingly necessary to conduct rigorous experimental research using more ecologically valid forms of cannabis among cancer patients. The present proposal seeks to utilize a rigorous placebo-controlled randomized trial to understand the effects of full spectrum hemp-derived CBD (fsCBD; CBD that contains a small amount of THC) and broad spectrum hemp- derived CBD (bsCBD; CBD that contains no THC) versus placebo on measures of sleep, pain, mood disturbance, subjective and objective cognitive functioning, and quality of life. These CBD products can be legally purchased and used over the counter across the U.S., so the results of this study have immediate application to and importance for cancer patients and their clinicians. The project aims are to 1) compare the effects of fsCBD vs bsCBD vs placebo on sleep quality, pain intensity/interference, mood disturbance (anxiety, depression), cognitive functioning, and quality of life over 8 weeks of sustained use and 2) compare the acute effects of fsCBD vs bsCBD vs placebo one and two hours after use on pain intensity, current mood, and objective cognitive task performance.