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THC and CBD for Insomnia in Cancer Patients

This study is looking at whether THC, or a combination of THC and CBD, can help improve sleep quality for people with solid organ cancer who also have insomnia. Many cancer patients experience sleep problems due to their illness or treatments. This trial will compare giving THC, THC/CBD, or a placebo (an inactive substance) as a liquid under the tongue. The main goal is to see how much your insomnia symptoms improve over four weeks. To join, you need to be at least 25 years old and have a solid organ cancer diagnosis. You can be in remission or have active disease, but your doctor must say you are healthy enough to participate.

Study design
This study is comparing three different treatments: THC, THC/CBD, and a placebo. It plans to include 69 participants.
What's involved
You would undergo blood sample collection and take a liquid tincture under your tongue. The study measures changes in sleep quality over four weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured from baseline to week 4.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07565974

THC Versus THC/CBD Versus Placebo to Improve Sleep Quality for Patients With Solid Organ Cancer and Insomnia

Not Yet Recruiting
PHASE2Ages 25+InterventionalSupportive care
Mayo Clinic
~69 participants
Updated 2026-09-02 on ClinicalTrials.gov
What's tested:Biospecimen CollectionPlacebo AdministrationSingle Agent Therapy

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Insomnia Sleep Index score
Measured over From baseline to week 4

Conditions

Insomnia
Malignant Solid Neoplasm

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InsomniaSolid Neoplasm

NCT07565974

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic in Rochester

    Rochester, Minnesotastudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Stacy D. D'Andre, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Insomnia Sleep Index scoreFrom baseline to week 4

    The Insomnia Sleep Index (ISI) is a brief screening tool used to assess insomnia symptoms and sleep patterns over the past week. It consists of 7 questions answered on a scale of 0 (not al all) to 4 (not very much). Total scores range from 0-28 with higher scores indicating greater severity of clinical insomnia.