Daily oral cannabis doses for people with cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants are randomized in a 3:1 ratio to receive daily oral cannabis (5 mg THC, 15 mg THC, or 15 mg THC + 15 mg CBD) or placebo for approximately four months in this Phase 1 interventional protocol. The primary goal is to measure safety and tolerability by comparing withdrawal rates and adverse events across dose groups versus placebo, with acute monitoring of vitals and device-recorded heart rate and oxygen saturation after dosing. Secondary outcomes include determining a tolerated dose for future studies and measuring effects on cancer symptom burden using the FACT Symptom Index at baseline, during dosing, and follow-up. Eligible adults have histologically confirmed locally advanced or metastatic solid tumors on a stable anti-cancer regimen and must pass screening tests such as a negative urine drug screen and adequate labs; the study is conducted at the University of Kentucky in Lexington.

Why it matters

Who can join: the full rules

Example Inclusion Criteria:

* 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.
* Patients with active cancers and currently under any line of treatment (please see notable exceptions in the exclusion criteria - patients taking checkpoint inhibitors and investigational agents will not be eligible - also exclusionary medications).
* 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)

Exclusion Criteria:

* 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

Where it's running

• University of Kentucky
  Lexington, Kentucky, United States Recruiting

Study contacts

• Principal investigator: Shanna Babalonis, PhD — University of Kentucky College of Medicine
• Study coordinator: Grayson Fuller, MPH
• Email: grayson.fuller@uky.edu
• Phone: 859-257-4581

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.