Trial Parameters
Brief Summary
Many cancer patients suffer from pain, sleep, and mood problems and are using cannabis to relieve these symptoms. Cannabis may provide such relief but may also produce negative side effects including cognitive impairment, an especially problematic issue for cancer patients, indicating more research on cannabis use in the cancer context is required. In this endeavor, the present study seeks to compare the use of hemp-derived CBD (Cannabidiol) with and without THC (Delta-9-tetrahydrocannabinol) versus placebo on measures of sleep, pain, mood, subjective and objective cognitive functioning, and quality of life within 185 cancer patients.
Eligibility Criteria
Inclusion Criteria: 1. Able to provide informed consent 2. Aged ≥25 years at Visit 1 (Baseline) 3. Have a diagnosis of any solid tumor type and is currently undergoing or has undergone either curative or palliative treatment in the past 18 months 4. Currently experiencing symptoms of sleep problems, pain, and/or mood disturbance (i.e., depression, anxiety) 5. Desire to use cannabis to treat their symptoms 6. Must not have been regularly using any cannabis products (more than 3x/month) in the last 6 months 7. Willing to practice acceptable methods of birth control until completing study medication Exclusion Criteria: 1. Report of illegal drug use (e.g., cocaine, methamphetamine) in the past 90 days 2. Current use of anti-epileptic medications (e.g., clobazam, sodium valproate, lamotrigine) 3. Current use of medications known to have major interactions with Epidiolex (e.g., buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybat