Clinical trial NCT06266611: Cannabis for Palliative Care in Cancer
Official title: Cannabis for Palliative Care in Cancer: A Placebo-controlled Randomized Trial of Full Spectrum Hemp-derived CBD/THC
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Sleep
Anxiety
Depression
Pain
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 185
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Able to provide informed consent
2. Aged ≥25 years at Visit 1 (Baseline)
3. 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
4. Currently experiencing symptoms of sleep problems, pain, and/or mood disturbance (i.e., depression, anxiety)
5. Desire to use cannabis to treat their symptoms
6. Must not have been regularly using any cannabis products (more than 3x/month) in the last 6 months
7. Willing to practice acceptable methods of birth control until completing study medication

Exclusion Criteria:

1. Report of illegal drug use (e.g., cocaine, methamphetamine) in the past 90 days
2. Current use of anti-epileptic medications (e.g., clobazam, sodium valproate, lamotrigine)
3. Current use of medications known to have major interactions with Epidiolex (e.g., buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide)
4. Current use of anti-psychotic medications
5. 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)
6. Liver function tests (Alanine transaminase \[ALT\] and Aspartate transaminase \[AST\]) levels ≥2x the upper normal limits
7. Moderate or severe liver disease
8. Past or current diagnosis, or family history of diagnosis, of psychosis; current major psychiatric illness, such as bipolar disorder, major depression, or schizophrenia
9. History of seizures
10. 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
11. Physician response to passive consent indicating contraindications for participation.
12. Unwilling to refrain from cannabis use other than study drug for the entire study duration
13. Men who consume more than 2 alcoholic beverages per day and women who consume more than 1 alcoholic beverage per day

Primary outcomes:
measure: Pain Interference
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Pain Intensity
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Pain Inventory
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Sleep Disturbance
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Sleep-Related Impairment
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Depression/Anxiety
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Fatigue
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Health Related Quality of Life
timeFrame: Baseline, 4 weeks, 8 weeks
measure: FACT-Cog Cognitive Function
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Stroop Task Test of Cognitive Function
timeFrame: Baseline, 4 weeks, 8 weeks
measure: DSST Test of Cognitive Function
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Conners Test of Cognitive Function
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Plasma Cannabinoids
timeFrame: Baseline, 4 weeks, 8 weeks
measure: PROMIS Pain Intensity (Right Now)
timeFrame: 4 weeks
measure: Drug Effects
timeFrame: 4 weeks
measure: ARCI-Marijuana Scale
timeFrame: 4 weeks
measure: Drug Effects - Mood
timeFrame: 4 weeks
measure: Drug Effects - Blood Cannabinoids
timeFrame: 4 weeks
Secondary outcomes:
measure: Polypharmacy for Pain
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Polypharmacy for Psychiatric Rx
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Polypharmacy for Sleep
timeFrame: Baseline, 4 weeks, 8 weeks
Other outcomes:
measure: Cancer Treatment Type
timeFrame: Baseline
measure: Cancer Disease Progression
timeFrame: Baseline, 4 weeks, 8 weeks
Locations:
city: Aurora
country: United States
facility: Anschutz Health Sciences Building
state: Colorado
Study officials:
References: