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

MC251001 - Phase II Randomized Double-Blinded Pilot Study of THC vs. THC/CBD (1:1) vs. Placebo for Insomnia in Patients With Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Malignant Solid Neoplasm; Insomnia
• Intervention / Treatment: Procedure: Biospecimen Collection; Drug: Single Agent Therapy; Drug: Single Agent Therapy; Drug: Placebo Administration

• Study Type: Interventional
• Enrollment (Estimated): 69
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
• Study Contact Backup: Name: Susie Lewis-Peters, RN; Phone Number: 507-266-1909

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Stacy D. D'Andre, MD
      • Contact: Ali Meyer, RN; Phone Number: 507-266-1160

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (THC tincture); 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; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Drug: Single Agent Therapy; Given THC tincture sublingually; Other Names: Monotherapy; Drug Monotherapy; Single Agent Treatment; Single Drug Therapy; Drug: Single Agent Therapy; Given THC/CBD tincture sublingually; Other Names: Monotherapy; Drug Monotherapy; Single Agent Treatment; Single Drug Therapy
Experimental: Arm II (THC/CBD tincture); 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; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Drug: Single Agent Therapy; Given THC tincture sublingually; Other Names: Monotherapy; Drug Monotherapy; Single Agent Treatment; Single Drug Therapy; Drug: Single Agent Therapy; Given THC/CBD tincture sublingually; Other Names: Monotherapy; Drug Monotherapy; Single Agent Treatment; Single Drug Therapy
Placebo Comparator: Arm III (placebo tincture); 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; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Drug: Placebo Administration; Given placebo tincture sublingually

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life Score	Assessed using the Linear Analog Scale Assessment (LASA) of Quality of Life (QOL) scale, which consists of a single question related to quality of life over the past week. The scale is answered on a scale of 0 (worst it can be) to 10 (best it can be). Total scores range from 0-10 with higher scores indicating greater quality of life.	From baseline to 4 weeks
Change in Daytime Sleepiness	As measured by the Patient-Reported Outcomes Measurement Information System Fatigue (PROMIS-Fatigue) Item Bank instrument. The PROMIS-Fatigue questionnaire, a subscale of the PROMIS-29, measures fatigue and related symptoms over the past seven days. It consists of four items rated on a scale of 1(not at all) to 5 (very much). Total scores range from 4-20 with higher scores indicating greater experience of fatigue.	From baseline to end of treatment (day 35)
Average amount of deep sleep	As measured by home electroencephalography (EEG). Will compare pair-wise between the three treatment arms. Will be compared using the same methodology as used for the primary endpoint.	From baseline to week 4
Average amount of light REM sleep	As measured by home EEG. Will compare pair-wise between the three treatment arms. Will be compared using the same methodology as used for the primary endpoint.	From baseline to week 4
Average time awake	As measured by home EEG. Will compare pair-wise between the three treatment arms. Will be compared using the same methodology as used for the primary endpoint.	From baseline to week 4
Amount of sleep per day	As measured by home EEG. Will compare pair-wise between the three treatment arms. Will be compared using the same methodology as used for the primary endpoint.	From baseline to week 4
Change in mood - PHQ-9	The Patient Health Questionnaire 9-item (PHQ-9) scale is a self-report questionnaire used to assess severity of depression over the last 2 weeks. The PHQ-9 consists of nine items rated on a scale of 0 (not at all) to 3 (nearly every day). Total scores range from 0-27 with higher scores indicating greater severity of depression symptoms.	From baseline to end of treatment (day 35)
Change in mood - GAD-7	The General Anxiety Disorder 7-item (GAD 7) scale is used to assess symptoms and feelings of anxiety over the past two weeks. The GAD-7 consists of 7 questions answered on a scale of 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 21 with higher scores indicating more severe anxiety symptoms.	From baseline to end of treatment (day 35)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Stacy D. D'Andre, MD, Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; Investigative Techniques; Therapeutics; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Drug Therapy
• Other Study ID Numbers: MC251001; 25-005620 (Other Identifier: Mayo Clinic Institutional Review Board)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No