Cannabis for Palliative Care in Cancer

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Sleep, Anxiety, Depression, Pain

In brief

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.

Key facts

Study ID: NCT06266611
Run by: University of Colorado, Boulder
People needed: 185
Starts: 2024-09-16
Expected to finish: 2028-06-30
Last updated by the study team: 2025-08-01

Who can join

Age: 25 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Able to provide informed consent
Aged ≥25 years at Visit 1 (Baseline)
Have a diagnosis of any solid tumor type and is currently undergoing or has undergone either curative or palliative treatment in the past 18 months
Currently experiencing symptoms of sleep problems, pain, and/or mood disturbance (i.e., depression, anxiety)
Desire to use cannabis to treat their symptoms
Must not have been regularly using any cannabis products (more than 3x/month) in the last 6 months
Willing to practice acceptable methods of birth control until completing study medication

You may not qualify if…

Report of illegal drug use (e.g., cocaine, methamphetamine) in the past 90 days
Current use of anti-epileptic medications (e.g., clobazam, sodium valproate, lamotrigine)
Current use of medications known to have major interactions with Epidiolex (e.g., buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide)
Current use of anti-psychotic medications
Current use of potent CYP2C19 or CYP3A4 inducers (e.g., Rifampin, apalutamide, carbamazepine, enzalutamide, ivosidenib9, lumacaftor, ivacaftor, phenytoin, St. John's wort, Fosphenytoin, Mitotane, Phenobarbital, Primidone)
Liver function tests (Alanine transaminase [ALT] and Aspartate transaminase [AST]) levels ≥2x the upper normal limits
Moderate or severe liver disease
Past or current diagnosis, or family history of diagnosis, of psychosis; current major psychiatric illness, such as bipolar disorder, major depression, or schizophrenia
History of seizures
For female participant of childbearing potential: Pregnant or lactating at the time of study enrollment or trying to become pregnant. Lack of childbearing potential confirmed by a history of amenorrhea for at least 12 consecutive months and serum FSH level within the laboratory's reference range for postmenopausal females OR documented bilateral oophorectomy and/or hysterectomy
Physician response to passive consent indicating contraindications for participation.
Unwilling to refrain from cannabis use other than study drug for the entire study duration
Men who consume more than 2 alcoholic beverages per day and women who consume more than 1 alcoholic beverage per day

Where it is running

Anschutz Health Sciences Building — Aurora, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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