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RECRUITING
NCT06601218
PHASE1

Impact of Daily Oral Cannabis Doses in Patients With Cancer

Sponsor: Shanna Babalonis, PhD

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-06-17

Completion Date

2030-12-01

Last Updated

2025-06-24

Healthy Volunteers

No

Interventions

DRUG

Oral cannabis low THC

4 months daily dosing with oral cannabis low THC

DRUG

Placebo Comparator

4 months of daily dosing with oral placebo

DRUG

Oral cannabis high THC

4 months of daily dosing with oral cannabis with high THC

DRUG

Oral cannabis THC/CBD

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

Locations (1)

University of Kentucky

Lexington, Kentucky, United States