THC Versus THC/CBD Versus Placebo to Improve Sleep Quality for Patients With Solid Organ Cancer a… (NCT07565974) | Clinical Trial Compass
Not Yet RecruitingPhase 2
THC Versus THC/CBD Versus Placebo to Improve Sleep Quality for Patients With Solid Organ Cancer and Insomnia
United States69 participantsStarted 2026-06-01
Plain-language summary
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.
Who can participate
Age range25 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 rather than completing worksheet, for screening only
* Willing to abstain from alcohol, anticholinergics, and benzodiazepines while on study
* If on opioids, must be a stable dose ≥ 30 days prior to randomization (no changes to prescriptions, this can include as needed \[PRN\] dosing) with no plans to increase during the study period
* White blood cell count (WBC) ≥ 3,000/mm\^3 (obtained ≤ 30 days prior to randomization)
* Hemoglobin ≥ 8 g/dL (obtained ≤ 30 days prior to randomization)
* Platelet count ≥ 50,000/mm\^3 (obtained ≤ 30 days prior to randomization)
* Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≤ 3 x upper limit of normal (ULN) (obtained ≤ 30 days prior to randomization)
* Glomerular filtration rate (GFR) \> 20 (obtained ≤ 30 days prior to randomization)
* Total bilirubin ≤ 1.5 x ULN (obtained ≤ 30 days prior to randomization)
* Negative pregnancy test done…