RecruitingPhase 1NCT06601218

Impact of Daily Oral Cannabis Doses in Patients With Cancer

A Phase I Study of the Effects of Cannabis on Cancer Burden: Placebo-Controlled, Double-Blind, Randomized Trial


Sponsor

Shanna Babalonis, PhD

Enrollment

80 participants

Start Date

Jun 17, 2025

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Oral cannabis THC/CBD, a drug called Oral cannabis high THC, and others for people with cancer and cancers, pain. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOral cannabis low THC

4 months daily dosing with oral cannabis low THC

DRUGPlacebo Comparator

4 months of daily dosing with oral placebo

DRUGOral cannabis high THC

4 months of daily dosing with oral cannabis with high THC

DRUGOral cannabis THC/CBD

4 months of daily dosing with oral cannabis with THC and CBD


Locations(1)

University of Kentucky

Lexington, Kentucky, United States

View Full Details on ClinicalTrials.gov

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NCT06601218


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