Recruiting
Phase 1

Cannabis

Sponsor:

Shanna Babalonis, PhD

Code:

NCT06601218

Conditions

Cancer

Cancers, Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Oral cannabis low THC

Placebo Comparator

Oral cannabis high THC

Oral cannabis THC/CBD

Study Details

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 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

Cancer

Cancers, Pain

Study ID

NCT06601218

Start date

Jun 17, 2025

Status verified date

Jul, 2026

Completion date

Dec 1, 2030

Anticipated

Primary completion date

Dec 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Example Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Arm 1: Placebo Cannabis

This arm will administer a placebo dose of oral cannabis (no active drug)

active comparator: Arm 2: Active Cannabis Low

This arm will administer an active low dose of cannabis

active comparator: Arm 3: Active Cannabis High

This arm will administer an active high dose of cannabis

active comparator: Arm 4: Active Cannabis (THC+CBD)

This arm will administer an active dose of cannabis (THC+CBD)

Interventions

Oral cannabis low THC

4 months daily dosing with oral cannabis low THC

Placebo Comparator

4 months of daily dosing with oral placebo

Oral cannabis high THC

4 months of daily dosing with oral cannabis with high THC

Oral cannabis THC/CBD

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

Primary outcome measure

  • Percent of participants that withdraw from the study or are removed due to adverse events [ Time Frame: 5.5 months (includes 2 week no-drug baseline, 4 months of daily dosing, 1 month of no-drug follow-up) ]

Central Contacts and Locations

Central contacts

Grayson Fuller, MPH

859-257-4581grayson.fuller@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40508

Contacts

Paul Nuzzo, MA

859-323-0002paul.nuzzo@uky.edu

More Information

Sponsor

Shanna Babalonis, PhD

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Shanna Babalonis, PhD on 2026-07-15.