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Cannabinoid
Cannabis for Palliative Care in Cancer (ARCTiC Trial)
Phase 2
Recruiting
Research Sponsored by University of Colorado, Boulder
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged ≥25 years at Visit 1 (Baseline)
Be older than 18 years old
Must not have
Current use of medications known to have major interactions with Epidiolex (e.g., buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide)
Current use of anti-psychotic medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks, 8 weeks
Summary
This trial aims to study the effects of hemp-derived CBD with and without THC on symptoms like pain, sleep, mood, and cognitive function in cancer patients. The study will compare these effects with a placebo
Who is the study for?
This trial is for cancer patients experiencing pain, sleep disturbances, and mood issues. Participants should be interested in using hemp-derived CBD to manage these symptoms. Specific eligibility criteria are not provided, but typically include factors like age range, cancer type/stage, and overall health status.
What is being tested?
The study compares the effects of two types of Cannabidiol (CBD) - one with THC (fsCBD) and one without THC (bsCBD), against a placebo. It aims to assess their impact on sleep quality, pain levels, mood changes, cognitive function, and life quality in 185 cancer patients.
What are the potential side effects?
Potential side effects may include cognitive impairment due to THC content in fsCBD. Other common cannabis-related side effects could involve dizziness, dry mouth, altered appetite or mood changes; however specific side effects will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 25 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not taking any medications that interact badly with Epidiolex.
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I am currently taking medication for psychosis.
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My liver tests are higher than normal.
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I have or had psychosis, bipolar disorder, major depression, or schizophrenia, or it runs in my family.
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I am not pregnant, breastfeeding, or trying to get pregnant, and I cannot have children due to menopause or surgery.
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I am currently taking medication for epilepsy.
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I have moderate or severe liver disease.
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I drink more than 2 (if male) or 1 (if female) alcoholic drinks daily.
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I am not currently taking strong medication that affects liver enzymes.
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I have a history of seizures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
ARCI-Marijuana Scale
Conners Test of Cognitive Function
DSST Test of Cognitive Function
+15 moreSecondary study objectives
Polypharmacy for Pain
Polypharmacy for Psychiatric Rx
Polypharmacy for Sleep
Other study objectives
Cancer Disease Progression
Cancer Treatment Type
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Full-Spectrum Hemp-Derived CBD (fsCBD)Experimental Treatment1 Intervention
8 weeks of use of a daily dose of cannabis (200mg CBD/4mg THC)
Group II: Broad-Spectrum Hemp-Derived CBD (bsCBD)Experimental Treatment1 Intervention
8 weeks of use of a daily dose of cannabis (200mg CBD)
Group III: PlaceboPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
University of Colorado, BoulderLead Sponsor
124 Previous Clinical Trials
29,236 Total Patients Enrolled
3 Trials studying Anxiety
776 Patients Enrolled for Anxiety