InsomniaPhase 2NCT07565974
THC Versus THC/CBD Versus Placebo to Improve Sleep Quality for Patients With Solid Organ Cancer and Insomnia
A Phase 2 study testing Biospecimen Collection and Single Agent Therapy in people with Insomnia and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Insomnia, Malignant Solid Neoplasm
- What is being tested?
- Biospecimen Collection and Single Agent Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 1 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Susie Lewis-Peters, RN contact
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Ali Meyer, RN, 507-266-1160
About this study
Official title: 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.
- Conditions
- Insomnia, Malignant Solid Neoplasm
- Being tested
- Biospecimen Collection, Placebo Administration, Single Agent Therapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Placebo AdministrationDrug
Given placebo tincture sublingually
Single Agent TherapyDrug
Also called Drug Monotherapy, Monotherapy, Single Agent Treatment, Single Drug Therapy
Given THC tincture sublingually
Single Agent TherapyDrug
Also called Drug Monotherapy, Monotherapy, Single Agent Treatment, Single Drug Therapy
Given THC/CBD tincture sublingually
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Biospecimen Collection; Drug: Placebo Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to week 4
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to end of treatment (day 35)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stacy D. D'Andre, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565974
- Sponsor's protocol ID
- MC251001
- Other IDs
- 25-005620
- Status last verified
- Aug 2026
- First submitted
- 24 Apr 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MC251001 - Phase II Randomized Double-Blinded Pilot Study of THC vs. THC/CBD (1:1) vs. Placebo for Insomnia in Patients With Cancer
- ClinicalTrials.gov ID
- NCT07565974
- Acronym / sponsor ID
- MC251001
- Conditions
- Insomnia, Malignant Solid Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (THC tincture) | Experimental | Procedure: Biospecimen Collection, Drug: Single Agent TherapyPatients 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. |
| Arm II (THC/CBD tincture) | Experimental | Procedure: Biospecimen Collection, Drug: Single Agent TherapyPatients 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. |
| Arm III (placebo tincture) | Placebo comparator | Procedure: Biospecimen Collection, Drug: Placebo AdministrationPatients 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (18 listed)
- 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:
- 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])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Arm I (THC tincture), Arm II (THC/CBD tincture), Arm III (placebo tincture) |
| Placebo AdministrationGiven placebo tincture sublingually | Drug | Arm III (placebo tincture) |
| Single Agent TherapyAlso: Drug Monotherapy, Monotherapy, Single Agent Treatment, Single Drug TherapyGiven THC tincture sublingually | Drug | Arm I (THC tincture) |
| Single Agent TherapyAlso: Drug Monotherapy, Monotherapy, Single Agent Treatment, Single Drug TherapyGiven THC/CBD tincture sublingually | Drug | Arm II (THC/CBD tincture) |
Primary outcome
Change in Insomnia Sleep Index score
Time frame: From 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.
8 secondary outcomes
Change in Quality of Life Score
Time frame: From baseline to 4 weeks
Change in Daytime Sleepiness
Time frame: From baseline to end of treatment (day 35)
Average amount of deep sleep
Time frame: From baseline to week 4
Average amount of light REM sleep
Time frame: From baseline to week 4
Average time awake
Time frame: From baseline to week 4
Amount of sleep per day
Time frame: From baseline to week 4
Change in mood - PHQ-9
Time frame: From baseline to end of treatment (day 35)
Change in mood - GAD-7
Time frame: From baseline to end of treatment (day 35)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susie Lewis-Peters, RN contact
Stacy D. D'Andre, MD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biospecimen Collection and Single Agent Therapy in people with Insomnia and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Sleep Index score (time frame: From baseline to week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.