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Impact of Daily Oral Cannabis Doses in Patients With Cancer

NCT06601218 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-06-24

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Shanna Babalonis, PhD

    lead OTHER

Principal Investigators

  • Shanna Babalonis, PhD · University of Kentucky College of Medicine

  • Zin Myint, MD · University of Kentucky College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-17
Primary Completion
2029-12-01
Completion
2030-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06601218 on ClinicalTrials.gov