A Phase 2 interventional study of Biospecimen Collection and Placebo Administration in Insomnia and Malignant Solid Neoplasm, sponsored by Mayo Clinic. Not yet recruiting at 1 site in United States. Open to participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Mayo Clinic · Phase 2, Interventional, and Supportive care
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's planned enrollment of 69 is close to the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
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
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
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
Undergo blood sample collection
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Given placebo tincture sublingually
Given THC tincture sublingually
Also known as: Drug Monotherapy, Monotherapy, Single Agent Treatment, Single Drug Therapy
Given THC/CBD tincture sublingually
Also known as: Drug Monotherapy, Monotherapy, Single Agent Treatment, Single Drug Therapy
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.
Time frame: From baseline to week 4
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to end of treatment (day 35)
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
Mayo Clinic