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NCT Number: NCT06266611

Cannabis for Palliative Care in Cancer

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.

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Key information

Conditions

Sleep Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Anschutz Health Sciences Building

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Harmony Soffer, BA

CONTACT

[email protected]

925-334-4031

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to provide informed consent
  • Aged ≥25 years at Visit 1 (Baseline)
  • 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
  • Currently experiencing symptoms of sleep problems, pain, and/or mood disturbance (i.e., depression, anxiety)
  • Desire to use cannabis to treat their symptoms
  • Must not have been regularly using any cannabis products (more than 3x/month) in the last 6 months
  • Willing to practice acceptable methods of birth control until completing study medication

Exclusion criteria

  • Report of illegal drug use (e.g., cocaine, methamphetamine) in the past 90 days
  • Current use of anti-epileptic medications (e.g., clobazam, sodium valproate, lamotrigine)
  • 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
  • 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)
  • Liver function tests (Alanine transaminase [ALT] and Aspartate transaminase [AST]) levels ≥2x the upper normal limits
  • Moderate or severe liver disease
  • Past or current diagnosis, or family history of diagnosis, of psychosis; current major psychiatric illness, such as bipolar disorder, major depression, or schizophrenia
  • History of seizures
  • 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
  • Physician response to passive consent indicating contraindications for participation.
  • Unwilling to refrain from cannabis use other than study drug for the entire study duration
  • Men who consume more than 2 alcoholic beverages per day and women who consume more than 1 alcoholic beverage per day

Treatment and study plan

fsCBD Cannabidiol

Drug

Full Spectrum hemp-derived CBD (fsCBD; 200mg CBD/4mg THC) capsules produced by Ecofibre/Ananda Hemp will be used

Placebo

Drug

Placebo arm; capsules produced by Ecofibre/Ananda Hemp will be used

bsCBD Cannabidiol

Drug

Broad spectrum hemp-derived CBD (bsCBD; 200mg CBD) capsules produced by Ecofibre/Ananda Hemp will be used

Primary outcomes

  1. Pain Interference

    Time frame: 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.

  2. Pain Intensity

    Time frame: 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.

  3. Pain Inventory

    Time frame: 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.

  4. Sleep Disturbance

    Time frame: 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.

  5. Sleep-Related Impairment

    Time frame: 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

  6. Depression/Anxiety

    Time frame: 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.

  7. Fatigue

    Time frame: 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.

  8. Health Related Quality of Life

    Time frame: 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.

  9. FACT-Cog Cognitive Function

    Time frame: 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.

  10. Stroop Task Test of Cognitive Function

    Time frame: Baseline, 4 weeks, 8 weeks

    Stroop Task

  11. DSST Test of Cognitive Function

    Time frame: Baseline, 4 weeks, 8 weeks

    Digit Symbol Substitution Task (DSST)

  12. Conners Test of Cognitive Function

    Time frame: Baseline, 4 weeks, 8 weeks

    Conners Continuous Performance Test - Version 3 (CPT-3)

  13. Plasma Cannabinoids

    Time frame: Baseline, 4 weeks, 8 weeks

    Plasma cannabinoid levels in participants will be measured from biological samples.

  14. PROMIS Pain Intensity (Right Now)

    Time frame: 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.

  15. Drug Effects

    Time frame: 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.

  16. ARCI-Marijuana Scale

    Time frame: 4 weeks

    Addiction Research Center Inventory - Marijuana Scale (ARCI-M). 12 True or false questions where more "true" answers indicate higher drug effects.

  17. Drug Effects - Mood

    Time frame: 4 weeks

    Profile of Mood States (POMS). Scores are between 28-140, with higher scores indicating higher drug effects.

  18. Drug Effects - Blood Cannabinoids

    Time frame: 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.

Secondary outcomes

  1. Polypharmacy for Pain

    Time frame: Baseline, 4 weeks, 8 weeks

    Use of pain medications

  2. Polypharmacy for Psychiatric Rx

    Time frame: Baseline, 4 weeks, 8 weeks

    Use of psychiatric medications

  3. Polypharmacy for Sleep

    Time frame: Baseline, 4 weeks, 8 weeks

    Use of sleep medications

Other outcomes

  1. Cancer Treatment Type

    Time frame: Baseline

    Type of treatment participant is using for cancer, including specific type of immunotherapy, if relevant and known

  2. Cancer Disease Progression

    Time frame: Baseline, 4 weeks, 8 weeks

    Assess cancer disease progression and report as outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Kyle Chrystal, BA

CONTACT

[email protected]

603-769-7718

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Registry information

Official study title

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

Acronym: ARCTiC

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 20, 2024
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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