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

NCT07565974 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: MC25100125-005620
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• Change in Insomnia Sleep Index score

  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.

  From baseline to week 4

Secondary Outcomes (8)

• Change in Quality of Life Score

  From baseline to 4 weeks

• Change in Daytime Sleepiness

  From baseline to end of treatment (day 35)

• Average amount of deep sleep

  From baseline to week 4

• Average amount of light REM sleep

  From baseline to week 4

• Average time awake

  From baseline to week 4

Study Arms (3)

Arm I (THC tincture)

EXPERIMENTAL

Patients receive THC tincture sublingually 60 minutes prior to bedtime QD on days 1-28. Patients start on day 1 at the lowest dose, for a minimum of 2 nights, and may increase the dose every 2 nights until they reach the maximum dose or they have acceptable sleep and remain at that dose. On days 29-34, patients continue to receive THC tincture sublingually 60 minutes prior to bedtime QD but titrate down to the lowest dose by day 34. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo blood and urine sample collection throughout the study.

Procedure: Biospecimen Collection; Drug: Single Agent Therapy

Arm II (THC/CBD tincture)

EXPERIMENTAL

Patients receive THC/CBD tincture sublingually 60 minutes prior to bedtime QD on days 1-28. Patients start on day 1 at the lowest dose, for a minimum of 2 nights, and may increase the dose every 2 nights until they reach the maximum dose or they have acceptable sleep and remain at that dose. On days 29-34, patients continue to receive THC/CBD tincture sublingually 60 minutes prior to bedtime QD but titrate down to the lowest dose by day 34. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo blood and urine sample collection throughout the study.

Procedure: Biospecimen Collection; Drug: Single Agent Therapy

Arm III (placebo tincture)

PLACEBO COMPARATOR

Patients receive placebo tincture sublingually 60 minutes prior to bedtime QD on days 1-28. Patients start on day 1 at the lowest dose, for a minimum of 2 nights, and may increase the dose every 2 nights until they reach the maximum dose or they have acceptable sleep and remain at that dose. On days 29-34, patients continue to receive placebo tincture sublingually 60 minutes prior to bedtime QD but titrate down to the lowest dose by day 34. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo blood and urine sample collection throughout the study.

Procedure: Biospecimen Collection; Drug: Placebo Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (THC tincture); Arm II (THC/CBD tincture); Arm III (placebo tincture)

Placebo Administration DRUG

Given placebo tincture sublingually

Arm III (placebo tincture)

Single Agent Therapy DRUG

Given THC tincture sublingually

Also known as: Drug Monotherapy, Monotherapy, Single Agent Treatment, Single Drug Therapy

Arm I (THC tincture)

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Specimen Handling; Drug Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Therapeutics

Study Officials

• Stacy D. D'Andre, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Susie Lewis-Peters, RN

CONTACT

507-266-1909

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)