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 range
25 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.