Cannabis for Palliative Care in Cancer (ARCTiC)

Cannabis for Palliative Care in Cancer: A Placebo-controlled Randomized Trial of Full Spectrum Hemp-derived CBD/THC

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Pain; Sleep; Anxiety
• Intervention / Treatment: Drug: fsCBD Cannabidiol; Drug: bsCBD Cannabidiol; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 185
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kyle Chrystal, BA; Phone Number: 603-769-7718; Email: kyle.chrystal@colorado.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Anschutz Health Sciences Building
      • Contact: Harmony Soffer, BA; Phone Number: 925-334-4031; Email: harmony.soffer@colorado.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo arm; capsules produced by Ecofibre/Ananda Hemp will be used
Experimental: Full-Spectrum Hemp-Derived CBD (fsCBD); 8 weeks of use of a daily dose of cannabis (200mg CBD/4mg THC)	Drug: fsCBD Cannabidiol; Full Spectrum hemp-derived CBD (fsCBD; 200mg CBD/4mg THC) capsules produced by Ecofibre/Ananda Hemp will be used
Experimental: Broad-Spectrum Hemp-Derived CBD (bsCBD); 8 weeks of use of a daily dose of cannabis (200mg CBD)	Drug: bsCBD Cannabidiol; Broad spectrum hemp-derived CBD (bsCBD; 200mg CBD) capsules produced by Ecofibre/Ananda Hemp will be used

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Interference	PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference. Total scores are between 8 and 40, with higher scores meaning more pain interference.	Baseline, 4 weeks, 8 weeks
Pain Intensity	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.	Baseline, 4 weeks, 8 weeks
Sleep Disturbance	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.	Baseline, 4 weeks, 8 weeks
Sleep-Related Impairment	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	Baseline, 4 weeks, 8 weeks
Depression/Anxiety	Depression Anxiety Stress Scale - 21 Item (DASS-21). Scores are between 0 and 63, with higher scores indicating more negative emotional states.	Baseline, 4 weeks, 8 weeks
Fatigue	PROMIS (Patient-Reported Outcomes Measurement Information System) Fatigue 4a. Scores range from 4-20, with higher scores indicating more fatigue.	Baseline, 4 weeks, 8 weeks
Health Related Quality of Life	Health Related Quality of Life Short Form 12 (SF-12). Scores range from 0-100 with higher scores indicating better health.	Baseline, 4 weeks, 8 weeks
Plasma Cannabinoids	Plasma cannabinoid levels in participants will be measured from biological samples.	Baseline, 4 weeks, 8 weeks
PROMIS Pain Intensity (Right Now)	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.	4 weeks
Drug Effects	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.	4 weeks
Drug Effects - Mood	Profile of Mood States (POMS). Scores are between 28-140, with higher scores indicating higher drug effects.	4 weeks
Drug Effects - Blood Cannabinoids	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.	4 weeks
Pain Inventory	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.	Baseline, 4 weeks, 8 weeks
FACT-Cog Cognitive Function	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.	Baseline, 4 weeks, 8 weeks
Stroop Task Test of Cognitive Function	Stroop Task	Baseline, 4 weeks, 8 weeks
DSST Test of Cognitive Function	Digit Symbol Substitution Task (DSST)	Baseline, 4 weeks, 8 weeks
Conners Test of Cognitive Function	Conners Continuous Performance Test - Version 3 (CPT-3)	Baseline, 4 weeks, 8 weeks
ARCI-Marijuana Scale	Addiction Research Center Inventory - Marijuana Scale (ARCI-M). 12 True or false questions where more "true" answers indicate higher drug effects.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polypharmacy for Pain	Use of pain medications	Baseline, 4 weeks, 8 weeks
Polypharmacy for Psychiatric Rx	Use of psychiatric medications	Baseline, 4 weeks, 8 weeks
Polypharmacy for Sleep	Use of sleep medications	Baseline, 4 weeks, 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer Treatment Type	Type of treatment participant is using for cancer, including specific type of immunotherapy, if relevant and known	Baseline
Cancer Disease Progression	Assess cancer disease progression and report as outcome	Baseline, 4 weeks, 8 weeks

Collaborators and Investigators

• Sponsor: University of Colorado, Boulder

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2024
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Anticonvulsants; Cannabidiol
• Other Study ID Numbers: 23-0982

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No