Can cannabis compounds help cancer patients sleep better?
NCT ID NCT07565974
First seen Jun 24, 2026 · Last updated Sep 03, 2026 · Updated 3 times
Summary
This study tests whether THC (with or without CBD) can improve sleep in people with solid organ cancer who have insomnia. About 69 participants will receive either THC, a THC/CBD mix, or a placebo as a liquid under the tongue. The goal is to see if these cannabis-based compounds help with sleep quality and overall well-being.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- THC and THC/CBD (cannabinoids)
- What this could lead to
- If it works, this could provide a new option for managing insomnia in cancer patients, improving sleep quality and quality of life.
- What could go wrong
- This is a small, early-phase pilot study. The results may not apply to all cancer patients, and cannabinoids can cause side effects like dizziness or mood changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 69 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Oct 2026
An estimate. Start dates often move.
- Expected to finish
-
Sep 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
25 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 ≤ 7 days prior to registration, for persons of childbearing potential only * Provide informed consent * Ability to complete questionnaires and diary by themselves or with assistance * Willingness to wear a home EEG monitor and have a blue-tooth device for recording (Smart phone, iPad) * Normal urine toxicology screen ≤ 7 days prior to randomization (abstinence from cannabinoids and other common drugs of abuse: cocaine, benzodiazepines, and methamphetamines) Exclusion Criteria: * Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown: * Pregnant persons * Nursing persons * Persons of childbearing potential or are able to father a child who are unwilling to employ adequate contraception (e.g., hormonal methods, barrier methods, intrauterine device, abstinence) during the study and for 14 days after their last dose * Currently using any other pharmacologic agents, over the counter medications or supplements to specifically treat insomnia for ≤ 7 days prior to randomization * Known primary sleep disorder (restless leg syndrome \[RLS\], uncontrolled apnea, narcolepsy) * Cannabis use ≤ 30 days prior to randomization * Active cardiac disease (symptomatic congestive heart failure \[CHF\], arrhythmias, untreated coronary artery disease \[CAD\]) * On warfarin, topiramate, clobazam, or other high-risk CYP3A4 substrates (amiodarone, macrolides, verapamil, fluoxetine, clotrimazole, ketoconazole) per pharmacy review * History of Human Papilloma Virus positive (HPV+) head and neck cancer * Any concomitant medications that, in the judgment of the treating physician or pharmacist, could result in an adverse drug effect (increase in substrate level); pharmacy e-consult will be conducted for each patient to determine CYP interactions * Patients with a history of psychotic disorders (including but not limited to schizophrenia, major depression with psychotic features, brief psychotic disorder). Patients with depression, manic/depression, or obsessive compulsive disorder (OCD) will need clearance from their mental health provider that these medical conditions are controlled and that the patient is appropriate for the study * Any known hypersensitivity to cannabis * Patients with CNS cancer or brain metastasis who have had or have seizures * History of, or current substance use disorder * Patients with electrocardiography (ECG) test with corrected QT interval (QTc) ≥ 450 msec for men and ≥ 470 msec for women * Current or past suicidal ideation or suicidal behavior within the last year, as assessed with the Columbia-Suicide Severity Rating Scale (C-SSRS) * Patients with history off falls in the past 6 months, or considered at risk for falling
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Insomnia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
-
Contact
Email: •••••@•••••
Locations
-
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a sleep drug help cirrhosis patients rest and think clearer?
- Can magnetic brain zaps ease the pain of a sleepless body?
- Can poor sleep make you hurt more? study probes Insomnia's link to pain
- Does soreness after exercise disrupt sleep more for people with insomnia?
- Can a vaccine stop GI cancers from returning?
- Can fixing insomnia help heavy drinkers cut back?