Actively Recruiting

Phase 2
Age: 25Years +
All Genders
NCT06266611

Cannabis for Palliative Care in Cancer

Led by University of Colorado, Boulder · Updated on 2025-08-01

185

Participants Needed

1

Research Sites

197 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Many cancer patients suffer from pain, sleep, and mood problems and are using cannabis to relieve these symptoms. Cannabis may provide such relief but may also produce negative side effects including cognitive impairment, an especially problematic issue for cancer patients, indicating more research on cannabis use in the cancer context is required. In this endeavor, the present study seeks to compare the use of hemp-derived CBD (Cannabidiol) with and without THC (Delta-9-tetrahydrocannabinol) versus placebo on measures of sleep, pain, mood, subjective and objective cognitive functioning, and quality of life within 185 cancer patients.

CONDITIONS

Official Title

Cannabis for Palliative Care in Cancer

Who Can Participate

Age: 25Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide informed consent
  • Aged 25 years or older at baseline
  • Diagnosed with any solid tumor and currently undergoing or have undergone curative or palliative treatment in the past 18 months
  • Currently experiencing symptoms of sleep problems, pain, and/or mood disturbances such as depression or anxiety
  • Desire to use cannabis to treat their symptoms
  • Not regularly using cannabis products (more than 3 times per month) in the last 6 months
  • Willing to practice acceptable birth control methods until completing study medication
Not Eligible

You will not qualify if you...

  • Use of illegal drugs (e.g., cocaine, methamphetamine) in the past 90 days
  • Current use of anti-epileptic medications such as clobazam, sodium valproate, or lamotrigine
  • Current use of medications known to interact with Epidiolex, including buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, and teriflunomide
  • Current use of anti-psychotic medications
  • Current use of potent CYP2C19 or CYP3A4 inducers such as Rifampin, apalutamide, carbamazepine, enzalutamide, ivosidenib, lumacaftor, ivacaftor, phenytoin, St. John's wort, Fosphenytoin, Mitotane, Phenobarbital, or Primidone
  • Liver function tests (ALT and AST) greater than twice the upper normal limit
  • Moderate or severe liver disease
  • Past or current diagnosis, or family history of psychosis; current major psychiatric illness including bipolar disorder, major depression, or schizophrenia
  • History of seizures
  • For females of childbearing potential: pregnant, lactating, trying to become pregnant, or lack of confirmed childbearing potential
  • Physician indicates contraindications for participation
  • Unwillingness to refrain from cannabis use other than study medication during the trial
  • Men who consume more than 2 alcoholic drinks per day or women who consume more than 1 alcoholic drink per day

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Anschutz Health Sciences Building

Aurora, Colorado, United States, 80045

Actively Recruiting

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Research Team

K

Kyle Chrystal, BA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Cannabis for Palliative Care in Cancer | DecenTrialz