Cannabis for Palliative Care in Cancer

Trial Title: Cannabis for Palliative Care in Cancer

NCT ID: NCT06266611

Condition: Sleep
Anxiety
Depression
Pain

Conditions: Official terms:
Depression
Cannabidiol

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Drug
Intervention name: fsCBD Cannabidiol
Description: Full Spectrum hemp-derived CBD (fsCBD; 200mg CBD/4mg THC) capsules produced by Ecofibre/Ananda Hemp will be used
Arm group label: Full-Spectrum Hemp-Derived CBD (fsCBD)

Intervention type: Drug
Intervention name: Placebo
Description: Placebo arm; capsules produced by Ecofibre/Ananda Hemp will be used
Arm group label: Placebo

Intervention type: Drug
Intervention name: bsCBD Cannabidiol
Description: Broad spectrum hemp-derived CBD (bsCBD; 200mg CBD) capsules produced by Ecofibre/Ananda Hemp will be used
Arm group label: Broad-Spectrum Hemp-Derived CBD (bsCBD)

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.

Criteria for 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

Gender: All

Minimum age: 25 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Anschutz Health Sciences Building

Address:
City: Aurora
Zip: 80045
Country: United States

Status: Recruiting

Contact:
Last name: Harmony Soffer, BA

Phone: 925-334-4031
Email: harmony.soffer@colorado.edu

Start date: July 15, 2024

Completion date: July 31, 2028

Lead sponsor:
Agency: University of Colorado, Boulder
Agency class: Other

Source: University of Colorado, Boulder

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06266611