Using cannabis to help cancer patients with pain, sleep, and mood issues
Cannabis for Palliative Care in Cancer: A Placebo-controlled Randomized Trial of Full Spectrum Hemp-derived CBD/THC
This study is testing whether hemp-derived CBD with or without THC can help cancer patients aged 25 and older feel less pain, sleep better, and improve their mood.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 185 (estimated) |
| Ages | 25 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Boulder Academic / other |
| Drugs / interventions | pexidartinib |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06266611 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of hemp-derived CBD (Cannabidiol) with and without THC (Delta-9-tetrahydrocannabinol) compared to a placebo in 185 cancer patients experiencing symptoms such as pain, sleep disturbances, and mood disorders. The aim is to assess improvements in sleep quality, pain relief, mood enhancement, cognitive functioning, and overall quality of life. Participants must be aged 25 or older, diagnosed with a solid tumor, and willing to explore cannabis as a treatment option. The study will also monitor potential side effects, particularly cognitive impairment.
Who should consider this trial
Good fit: Ideal candidates are cancer patients aged 25 and older who are experiencing symptoms of sleep problems, pain, and mood disturbances and are interested in using cannabis for relief.
Not a fit: Patients who have been using cannabis products regularly in the past six months or those with certain drug interactions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for cancer patients struggling with pain, sleep, and mood issues.
How similar studies have performed: While cannabis use in palliative care is being explored, this specific approach comparing CBD and THC in cancer patients is relatively novel and requires further investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado
- Anschutz Health Sciences Building — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Kyle Chrystal, BA
- Email: kyle.chrystal@colorado.edu
- Phone: 603-769-7718
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.