Actively Recruiting
Impact of Daily Oral Cannabis Doses in Patients With Cancer
Led by Shanna Babalonis, PhD · Updated on 2025-06-24
80
Participants Needed
1
Research Sites
284 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 receive an active cannabis dose in the study. There is a 1/4 (or 25% chance) that a participant will receive a placebo dose (meaning a blank dose/no cannabis/no active drug). The goals of this study are to determine 1) the safety and tolerability of cannabis in individuals with cancer and 2) if cannabis can help with the side effects of cancer and cancer treatment - including nausea and vomiting, appetite, pain, sleep, and quality of life.
CONDITIONS
Official Title
Impact of Daily Oral Cannabis Doses in Patients With Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced or metastatic solid tumor cancer
- Currently undergoing anti-cancer therapy for at least one month prior to enrollment
- Age 18 years or older
- Adequate organ and marrow function demonstrated by ECG and lab tests at baseline
- Negative urine drug screen for illicit drugs, THC, and CBD before randomization
- Ability to understand and willing to sign written informed consent
- Individuals able to become pregnant must agree to use effective contraception during the study period
You will not qualify if you...
- History of hypersensitivity to cannabis or cannabinoids
- Current regular use of cannabis, THC-containing medications, cannabidiol, or over-the-counter CBD oil
- Use of checkpoint inhibitors or other drugs with potential cannabinoid interactions
- Use of investigational agents within 3 months prior to enrollment
- Cardiac conditions that contraindicate cannabis use
- Diagnosis of HPV-related cancer
- Allergy to any ingredient in the edible dose
- Psychiatric illness or social situations limiting study compliance (e.g., bipolar disorder, psychosis, severe depression or anxiety)
- Pregnant or breastfeeding
- Moderate to severe drug or alcohol use disorder or positive drug/alcohol tests at screening
- History of seizure disorder or epilepsy
- Current legal obligations such as parole, probation, or incarceration
- Enrollment in substance use treatment
- Self-reported recent use of cannabis, synthetic cannabinoids, illicit drugs, or daily alcohol use
- Positive urine or breathalyzer tests for cannabinoids, synthetic cannabinoids, alcohol, or illicit drugs during screening
- Lack of access to internet or devices for daily video call participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Kentucky
Lexington, Kentucky, United States, 40508
Actively Recruiting
Research Team
G
Grayson Fuller, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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