Cannabidiol and Older Adult Cannabis Users
Purpose
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.
Conditions
- Sleep
- Anxiety
- Depression
- Pain
Eligibility
- Eligible Ages
- Over 60 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- At least 60 years of age - Able to provide informed consent - Must have used a cannabis product at least once with no negative effects - Must not have been regularly using any cannabis products (<3x/month) in the last 6 months - Female participants must be postmenopausal - Liver function tests (Alanine transaminase (ALT) and - Aspartate transaminase (AST)) must show levels no greater than 2x the upper normal limits for age - Must be currently taking medication/s for pain, sleep, and/or mood
Exclusion Criteria
- Blood alcohol level > 0 at screening (to sign consent form) - Report of other drug use (cocaine, opiates, methamphetamine) in the past 90 days or fail urine screen for any of these drugs - Past or current diagnosis, or family history of diagnosis of psychosis - Current use of anti-epileptic medications (e.g. clobazam, sodium valproate) - Current use of medications known to have major interactions with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, and/or teriflunomide). - Current use of antipsychotic medications - Currently undergoing chemotherapy (to prevent drug interactions)
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- University of Colorado, Boulder
