Mayo Clinic
This phase II trial compares THC versus (vs.) THC with CBD vs. placebo to improve sleep quality for patients with solid organ cancer and insomnia. Many patients who are diagnosed with cancer struggle with sleep disorders after receiving a diagnosis. Insomnia is the most reported sleep disturbance amongst cancer patients, often stemming from physical changes from tumor growth and surgery, side effects from supportive care and chemotherapy, and stress associated with the diagnosis. THC with or without CBD may improve insomnia symptoms and sleep quality.
Inclusion Criteria: * Age ≥ 25 years * History of solid organ (not hematologic) cancer diagnosis (except patients with central nervous system \[CNS\] cancer who have history of seizures or untreated brain metastasis). Patients may be either in remission or have active disease. Patients must be considered medically fit by their treating physician to participate in the study * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 * History of insomnia for which the patient would like an intervention * Insomnia Severity Index Score ≥ 15. Patients can answer questions orally…
Undergo blood sample collection
Given placebo tincture sublingually
Given THC tincture sublingually
Given THC/CBD tincture sublingually
Arctuva estimate
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