Cannabidiol and Older Adult Cannabis Users
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of Colorado, Boulder
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- fsCBD Cannabidiol
- bsCBD Cannabidiol
- Placebo
Treatment groups
385 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov