Status:
RECRUITING
Impact of Daily Oral Cannabis Doses in Patients With Cancer
Lead Sponsor:
Shanna Babalonis, PhD
Conditions:
Cancer
Cancers, Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will enroll patients with cancer and participants will be randomized to receive one dose of cannabis for approximately 4 months. There is a 3/4 (or 75%) chance that a participant will recei...
Detailed Description
Primary Objective: To evaluate the safety and tolerability of daily oral cannabis administration (5 mg THC, 15 mg THC, 15 mg THC+15 mg CBD) relative to placebo in patients with cancer who are on an ac...
Eligibility Criteria
Inclusion
- Example
- 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
- 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
Key Trial Info
Start Date :
June 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06601218
Start Date
June 17 2025
End Date
December 1 2030
Last Update
June 24 2025
Active Locations (1)
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1
University of Kentucky
Lexington, Kentucky, United States, 40508