Cannabis for Palliative Care in Cancer

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Boulder
Study ID
NCT06266611
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Sep 16, 2024
Status verified
Jul 2025
Primary completion
May 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
185 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Full-Spectrum Hemp-Derived CBD (fsCBD)
    8 weeks of use of a daily dose of cannabis (200mg CBD/4mg THC)
  • Experimental: Broad-Spectrum Hemp-Derived CBD (bsCBD)
    8 weeks of use of a daily dose of cannabis (200mg CBD)
  • Placebo Comparator: Placebo

Primary Outcome Measure

Pain Interference [ Time Frame: Baseline, 4 weeks, 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Anschutz Health Sciences BuildingAuroraColorado80045
Harmony Soffer, BA
[email protected]
925-334-4031

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