Cannabidiol and Older Adult Cannabis Users

Part of paid clinical trials in Boulder, Colorado.

Sponsor
University of Colorado, Boulder
Study ID
NCT06290063
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
60 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
  • bsCBD Cannabidiol — DRUG
    Broad spectrum hemp-derived CBD (bsCBD; 200mg CBD) capsules produced by Ecofibre/Ananda Hemp will be used
  • Placebo — DRUG
    Placebo arm; capsules produced by Ecofibre/Ananda Hemp will be used

Study Details

Cannabis use increased 10 fold among adults over the age of 65 between 2014 and 2016 but very little data exists on the extent of their harmful effects on health and behavior. The overarching goal of this project is to test a novel harm reduction strategy in which older individuals who seek to use cannabis for pain, anxiety or mood problems (depression/anxiety) will be randomly assigned to one of three conditions in an 8 week randomized controlled trial: hemp-derived CBD+THC, hemp-derived CBD-THC, or placebo. This work has the ability to directly inform individual choices regarding the use of cannabis products among older adults, and direct policy decisions regulating cannabis formulations on the legal market.

Key Dates

Start date
May 1, 2024
Status verified
Jun 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
385 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

Subjective Motor Function [ Time Frame: Baseline, 4 weeks, 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado at BoulderBoulderColorado80309
Ellie Sundali, BA
[email protected]

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