protocolSection identificationModule nctId: NCT06266611, orgStudyIdInfo id: 23-0982, briefTitle: Cannabis for Palliative Care in Cancer, acronym: ARCTiC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2028-07-31, completionDateStruct date: 2028-07-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Boulder, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Sleep, conditions: Anxiety, conditions: Depression, conditions: Pain, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 185, type: ESTIMATED, armsInterventionsModule interventions name: fsCBD Cannabidiol, interventions name: Placebo, interventions name: bsCBD Cannabidiol, outcomesModule primaryOutcomes measure: Pain Interference, primaryOutcomes measure: Pain Intensity, primaryOutcomes measure: Pain Inventory, primaryOutcomes measure: Sleep Disturbance, primaryOutcomes measure: Sleep-Related Impairment, primaryOutcomes measure: Depression/Anxiety, primaryOutcomes measure: Fatigue, primaryOutcomes measure: Health Related Quality of Life, primaryOutcomes measure: Cognitive Function, primaryOutcomes measure: Cognitive Function, primaryOutcomes measure: Cognitive Function, primaryOutcomes measure: Cognitive Function, primaryOutcomes measure: Plasma Cannabinoids, primaryOutcomes measure: PROMIS Pain Intensity (Right Now), primaryOutcomes measure: Drug Effects, primaryOutcomes measure: Drug Effects, primaryOutcomes measure: Drug Effects - Mood, primaryOutcomes measure: Drug Effects - Cognitive, primaryOutcomes measure: Drug Effects - Cognitive, primaryOutcomes measure: Drug Effects - Cognitive, primaryOutcomes measure: Drug Effects - Blood Cannabinoids, secondaryOutcomes measure: Polypharmacy, secondaryOutcomes measure: Polypharmacy, secondaryOutcomes measure: Polypharmacy, eligibilityModule sex: ALL, minimumAge: 25 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anschutz Health Sciences Building, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Harmony Soffer, BA, role: CONTACT, phone: 925-334-4031, email: harmony.soffer@colorado.edu, geoPoint lat: 39.72943, lon: -104.83192, hasResults: False