Cannabis for Palliative Care in Cancer (ARCTiC)

University of Colorado Boulder (CU)

Status and phase: Enrolling; Phase 2

Conditions: Depression; Anxiety; Pain; Sleep

Treatments: Drug: fsCBD Cannabidiol; Drug: bsCBD Cannabidiol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06266611

23-0982

Details and patient eligibility

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.

Enrollment: 185 estimated patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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185 participants in 3 patient groups, including a placebo group

Full-Spectrum Hemp-Derived CBD (fsCBD)

Experimental group

Description:

8 weeks of use of a daily dose of cannabis (200mg CBD/4mg THC)

Treatment:

Drug: fsCBD Cannabidiol

Broad-Spectrum Hemp-Derived CBD (bsCBD)

Experimental group

Description:

8 weeks of use of a daily dose of cannabis (200mg CBD)

Treatment:

Drug: bsCBD Cannabidiol

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo