Cannabis Gummy for Sleep and Quality of Life in Cancer Patients
This study, called the "Pillow Trial," is looking at whether a cannabis gummy can help cancer patients sleep better and improve their quality of life. Many people with cancer experience sleep problems, which can affect how they feel overall. This trial will compare a nightly cannabis gummy to usual care (what you would normally receive) for 30 days. You might be able to join if you are an adult with cancer, either newly diagnosed or already receiving treatment, and are experiencing sleep disturbances. The researchers want to see if the cannabis gummy is safe and if it helps with sleep and quality of life. The study aims to enroll 50 participants.
- Study design
- This is an interventional study where participants will be randomly assigned to either receive a nightly cannabis gummy or continue with their usual care. It plans to enroll 50 participants.
- What's involved
- If you participate, you would take a nightly cannabis-based gummy for 30 days or receive usual care. You would also have blood samples collected and complete various assessments, including questionnaires.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for adverse events and protocol adherence for up to 31 days, and for completion of assessments for up to 38 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07658677
Cannabis Gummy for the Improvement of Sleep and Quality of Life in Patients With Cancer, Pillow Trial
Not Yet Recruiting
PHASE1Ages 18+InterventionalSupportive careTheodore Brasky PhDInvestigator-initiated
~50 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:ActigraphyBest PracticeBiospecimen CollectionEcological Momentary AssessmentQuestionnaire 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
Incidence of adverse events (AE)
Measured over Up to day 31
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesOhio1
Study leadership
- Theodore Brasky, PhD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
New patients in the OSUCCC's Palliative Care clinics who have histologically or cytologically confirmed malignancy of any anatomic site. This applies to either newly diagnosed cancer or those with preexisting malignancy receiving treatment
Reported sleep disturbance (≥ 4) in the Edmonton Symptom Assessment System, the clinic's symptom screener administered at every visit
Exclusion
If patients are currently receiving cancer therapy, they must have been taking their current anti-cancer intervention/ therapy regimen for at least one month prior to enrollment (to ensure no safety or toxicity issues with study drug initiation)
Age ≥ 18 years
English speaking with the ability to understand and the willingness to sign a written informed consent document
Eastern Cooperative Oncology Group performance status ≤ 3
Total bilirubin: \< 3X institutional upper limit of normal (1.5 mg/dl) (within the past 3 months or predating their current cancer regimen)
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]): \< 3X institutional upper limit of normal (within the past 3 months or predating their current cancer regimen)
AST: \< 3X institutional upper limit of normal (10-39 U/L)
ALT: \< 3X institutional upper limit of normal (10-52 U/L)
Glomerular filtration rate (GFR): ≥ 30 mL/min/1.73 m\^2 using Cockcroft-Gault (within the past 3 months or predating their current cancer regimen)
Normal electrocardiogram (EKG); or non-normal EKG with no significant arrhythmias or severe congestive heart failure (CHF). A normal EKG defined as sinus rhythm with no ST or T wave changes any clinically concerning EKGs will be reviewed by the study physician to determine participant eligibility into the study (within the past 3 months or predating their current cancer regimen)
Patients are allowed to take any type of analgesic pain medication at baseline, but must be on a stable dose of pain medication for two weeks and not requiring rapid dose escalation
Individuals able to become pregnant will agree to practice a highly effective form of birth control. Contraception including oral birth control pills, intrauterine device (IUD), condoms, abstinence must be used alone or in combination for the duration of enrollment
Agree to study requirements, as described in the consent form:
No driving, use of heavy machinery, or caring for children for 12 hours (hrs) after dose
Wearing fitness tracker 24/7 for the duration of the study and are able to charge the device once per week.
No cannabis (i.e., outside of provided study drug), or illegal drug use (e.g., methamphetamine, non-prescription opioids or fentanyl)
Calls so that study staff can monitor dosing
Completing weekly ecological momentary assessment (EMA) questionnaires
History of hypersensitivity to cannabis, THC, or CBD
Current, regular use of cannabis/marijuana, THC-containing prescription medications (dronabinol/Marinol/Syndros, nabilone/Cesamet), prescription CBD (Epidiolex), or over-the-counter CBD oil within the past 6 months
Concurrent use of medications that are contraindicated with medical cannabis: valproate, clobazam, warfarin, fluoxetine, disulfiram, tamoxifen, Ibrance, Gleevec, amphetamines, buprenorphine, methadone, alprazolam, amiodarone, fluconazole, ketoconazole, itraconazole, clarithromycin, ritonavir, erythromycin. The study physician will review eligibility for participants taking medications that are moderate to strong inhibitors and inducers of enzymes CYP3A4 (epidiolex, marinol), CYP2C19 (epidiolex), and CYP2C9 (marinol)
The following medications if being used to treat sleep: benzodiazepines or nonbenzodiazepine medications, antidepressants, antihistamines, supplements (e.g., melatonin)
Cardiac conditions contraindicated for cannabis use, moderate/severe or unstable CHF, symptomatic valvular heart disease, and uncontrolled arrhythmias as reviewed by the study team physician. Investigators will consult with a cardio-oncologist if needed
Abnormal screening ECG with corrected QT (QTc) intervals of ≥ 450 (males) and ≥ 460 (females), as reviewed by the study physician
Baseline orthostatic hypotension drop of blood pressure (BP) ≥ 20 mmHg, or in diastolic BP of ≥ 10mmHg or experience of lightheadedness or dizziness during the test
Based on a measurement at baseline, we will exclude participants with current hypertension defined as BP \> 165/100, abnormal ECG results or a resting heart rate defined as \> 110bpm
Concomitant use of checkpoint inhibitors (e.g., anti-PD1, PDL1, CTLA4)
Current use of investigational agents or \< 3 months after the use of investigational agents
Diagnosis of sleep apnea
Allergy to any constituent/ingredient contained in the edible doses
Psychiatric illness/social situations that would limit adherence with study requirements (e.g., bipolar disorder, psychosis). Mild/moderate mood disorders treated by medications that are not expected to increase cannabis-induced sedation/impairment are acceptable with physician approval
Any known or suspected history or family history of schizophrenia, bipolar disorder, or other psychotic illness
Pregnant or breastfeeding
Sole caretaker of minor children living in the household
History of seizure disorder, epilepsy (controlled or uncontrolled)
Current legal obligations (parole, probation, incarceration)
Current substance use disorder (including cannabis use disorder), or currently enrolled in substance use treatment
Self-reported cannabis and synthetic cannabinoid use in the past 6 months (medical or non-medical use is exclusionary)
Self-reported illicit drug use in past 60 days (ex: methamphetamine, heroin, illicit fentanyl) or self-reported daily alcohol use
No access to internet/data or devices needed to participate in video calls (day 14) and EMA assessments
What this trial measures
- Incidence of adverse events (AE)Up to day 31
Will be evaluated by assessing the frequency, grade, and type of AE reported by participants. The frequency and percentage of participants experiencing each grade of AE will be reported for both groups.
- Proportion of participants who adhere to the study protocolUp to day 31
Includes consistent use of actigraphy, completion of self-reported measures, and measurement of self-reported cross-over events. Adherence rates will be analyzed using descriptive statistics. Logistic regression will be used to identify factors associated with adherence.
- Proportion of participants who complete all study assessmentsUp to day 38
Logistic regression will be used to identify factors associated with retention.