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Oral Cannabis Doses for Cancer Patients

This study is looking at how daily oral cannabis affects people with cancer. Researchers want to see if different types of cannabis – low THC, high THC, or THC/CBD combination – are safe and well-tolerated. They also want to find out if cannabis can help with common side effects of cancer and its treatments, such as nausea, pain, sleep problems, and overall quality of life. You would receive one type of cannabis or a placebo (a pill with no active drug) for about 4 months. There's a 75% chance you'd receive an active cannabis dose. The study aims to enroll 80 participants with locally advanced or metastatic solid tumors.

Study design
This is an interventional study that will randomize 80 participants to receive one of four daily oral cannabis doses or a placebo. It is not specified if the study is blinded.
What's involved
You would take a daily oral dose for 4 months, with a 2-week baseline period before and a 1-month follow-up period after dosing.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 1 month after the 4-month daily dosing period, for a total of 5.5 months including a baseline period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06601218

Impact of Daily Oral Cannabis Doses in Patients With Cancer

Recruiting
PHASE1Ages 18+InterventionalBasic science
Shanna Babalonis, PhD
~80 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:Oral cannabis low THCPlacebo ComparatorOral cannabis high THCOral cannabis THC/CBD

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of participants that withdraw from the study or are removed due to adverse events
Measured over 5.5 months (includes 2 week no-drug baseline, 4 months of daily dosing, 1 month of no-drug follow-up)

Conditions

Cancer
Cancers, Pain

Explore related trials

Solid Neoplasm

NCT06601218

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Kentucky

    Lexington, Kentuckystudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Shanna Babalonis, PhD · PRINCIPAL_INVESTIGATOR · University of Kentucky College of Medicine
  • Zin Myint, MD · PRINCIPAL_INVESTIGATOR · University of Kentucky College of Medicine

Who to contact

Grayson Fuller, MPH
[email protected]
859-257-4581
Email the study team

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Eligibility criteria

Inclusion

Histologically or cytologically confirmed locally advanced or metastatic solid tumors with any types. This applies to either newly diagnosed cancer or preexisting ones on treatment.

Exclusion

Patients have been taking their current anti-cancer therapy regimen for at least one month prior to enrollment (to ensure no safety or toxicity issues with study drug initiation).
Age ≥18 years.
ECG and lab values demonstrating adequate organ and marrow function at baseline (pre-study).
Negative urine drug screen for all illicit drugs and THC, CBD prior to randomization
Ability to understand and the willingness to sign a written informed consent document
Individuals able to become pregnant will agree to practice an effective form of contraception (e.g., oral birth control pills, condoms, abstinence) for the duration of enrollment (note: urine pregnancy testing will occur monthly)
History of hypersensitivity to cannabis or cannabinoids
Current, regular use of cannabis/marijuana or THC-containing medications (dronabinol, nabilone) or cannabidiol (Epidiolex) or over-the-counter (OTC) CBD oil.
Concomitant use of checkpoint inhibitors (e.g., anti-PD1, PDL1, CTLA4) or other drugs for which an cannabinoid interaction may occur.
Current use of investigational agents, \<3 months after the use of investigational agents
Cardiac conditions contraindicated for cannabis use
Diagnosis of HPV-related cancer, as there is some evidence that cannabis is contraindicated
Allergy to any constituent/ingredient contained in the edible dose
Psychiatric illness/social situations that would limit compliance with study requirements (e.g., bipolar disorder, psychosis, severe depression/anxiety).
Pregnant or breastfeeding (note: participants will be tested for pregnancy (urine sample) once per month during enrollment)
Current moderate/severe drug or alcohol use disorder (including cannabis use disorder), positive urine drug screen for illicit drugs or cannabis, or positive alcohol (breathalyzer) during screening
History of seizure disorder, epilepsy (controlled or uncontrolled)
Current legal obligations (parole, probation, incarceration, urine drug screen requirements as part of parole/probation/previous incarceration)
Currently enrolled in substance use treatment
Self-reported cannabis and synthetic cannabinoid use in the past 30 days (medical or non-medical use is exclusionary)
Self-reported illicit drug use in past 60 days (ex: methamphetamine, heroin, illicit fentanyl)
Self-reported daily alcohol use
Providing a urine sample testing positive for cannabinoids (THC, CBD) or synthetic cannabinoids (K2, Spice-like compounds)
Providing a sample testing positive for alcohol (breathalyzer) or non-medical use of other drugs (methamphetamine, cocaine) during screening; testing positive during enrollment will lead to discontinuation of the participant's enrollment
No access to internet/data or devices needed to participate in daily video calls

What this trial measures

  • Percent of participants that withdraw from the study or are removed due to adverse events5.5 months (includes 2 week no-drug baseline, 4 months of daily dosing, 1 month of no-drug follow-up)

    The percent of patients who elect to withdrawal from the study or removed by physician/investigators due AEs or safety concerns in each group will be measured and compared to the placebo group.