Anxiety, Depression, Pain, Sleep
Conditions
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.
Interventions
Full Spectrum hemp-derived CBD (fsCBD; 200mg CBD/4mg THC) capsules produced by Ecofibre/Ananda Hemp will be used
DRUGPlacebo
Placebo arm; capsules produced by Ecofibre/Ananda Hemp will be used
Broad spectrum hemp-derived CBD (bsCBD; 200mg CBD) capsules produced by Ecofibre/Ananda Hemp will be used
Sponsors
University of Colorado, Boulder
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drug Effects - Blood Cannabinoids | 4 weeks | Acute plasma cannabinoid levels in participants will be measured from blood samples pre-drug administration, on-hour post drug administration, and 2-hours post drug administration at week 4 appointment. |
| Plasma Cannabinoids | Baseline, 4 weeks, 8 weeks | Plasma cannabinoid levels in participants will be measured from biological samples. |
| PROMIS Pain Intensity (Right Now) | 4 weeks | PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Intensity (Right Now). Scores are between 0-10, with 0 being no pain and 10 being the worst imaginable pain. |
| Drug Effects | 4 weeks | Drug Effects Questionnaire (DEQ). Six questions about drug effects with possible answers of not at all, somewhat, and extremely, where higher scores indicate higher drug effects. |
| ARCI-Marijuana Scale | 4 weeks | Addiction Research Center Inventory - Marijuana Scale (ARCI-M). 12 True or false questions where more true answers indicate higher drug effects. |
| Drug Effects - Mood | 4 weeks | Profile of Mood States (POMS). Scores are between 28-140, with higher scores indicating higher drug effects. |
| Pain Interference | Baseline, 4 weeks, 8 weeks | PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference. Total scores are between 8 and 40, with higher scores meaning more pain interference. |
| Pain Intensity | Baseline, 4 weeks, 8 weeks | PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Intensity (7-day). Scores are between 0-10, with 0 being no pain and 10 being the worst imaginable pain. |
| Pain Inventory | Baseline, 4 weeks, 8 weeks | Brief Pain Inventory (BPI) survey. Measures pain levels, pain interference, and relief from medication, and includes diagrams for labeling pain. For pain levels, various questions ask participants to rate pain on a scale of 0-10, 0 being no pain and 10 being pain as bad as you can imagine. For questions about pain interference, each question is on a scale of 0-10, where 0 does not interfere and 10 completely interferes. BPI is scored as an average of each subsection, where a higher average suggests greater severity of pain/more interference. |
| Sleep Disturbance | Baseline, 4 weeks, 8 weeks | PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance 4a. Scores are separated between the first question (sleep quality) and the remaining 7 questions. For the first question, scores are between 1 and 5, with 1 being very poor sleep quality and 5 being very good sleep quality. The remaining 7 questions are scored individually on a scale of 1--5; for some questions, higher scores mean less disturbance, and for others, a higher score means more disturbance. |
| Sleep-Related Impairment | Baseline, 4 weeks, 8 weeks | PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep-Related Impairment 4a. Scores are between 4 and 20, with higher scores indicating more sleep-related impairment |
| Depression/Anxiety | Baseline, 4 weeks, 8 weeks | Depression Anxiety Stress Scale - 21 Item (DASS-21). Scores are between 0 and 63, with higher scores indicating more negative emotional states. |
| Fatigue | Baseline, 4 weeks, 8 weeks | PROMIS (Patient-Reported Outcomes Measurement Information System) Fatigue 4a. Scores range from 4-20, with higher scores indicating more fatigue. |
| Health Related Quality of Life | Baseline, 4 weeks, 8 weeks | Health Related Quality of Life Short Form 12 (SF-12). Scores range from 0-100 with higher scores indicating better health. |
| FACT-Cog Cognitive Function | Baseline, 4 weeks, 8 weeks | Functional Assessment of Cognitive Function - Cognitive (FACT-Cog). Scores are transformed such that scores range from 0-132 and higher scores indicate a better quality of life/cognitive function. |
| Stroop Task Test of Cognitive Function | Baseline, 4 weeks, 8 weeks | Stroop Task |
| DSST Test of Cognitive Function | Baseline, 4 weeks, 8 weeks | Digit Symbol Substitution Task (DSST) |
| Conners Test of Cognitive Function | Baseline, 4 weeks, 8 weeks | Conners Continuous Performance Test - Version 3 (CPT-3) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Polypharmacy for Pain | Baseline, 4 weeks, 8 weeks | Use of pain medications |
| Polypharmacy for Psychiatric Rx | Baseline, 4 weeks, 8 weeks | Use of psychiatric medications |
| Polypharmacy for Sleep | Baseline, 4 weeks, 8 weeks | Use of sleep medications |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cancer Disease Progression | Baseline, 4 weeks, 8 weeks | Assess cancer disease progression and report as outcome |
| Cancer Treatment Type | Baseline | Type of treatment participant is using for cancer, including specific type of immunotherapy, if relevant and known |
Countries
United States
Contacts
Primary ContactKyle Chrystal, BA
Outcome results
None listed