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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
fsCBD Cannabidiol
DrugFull Spectrum hemp-derived CBD (fsCBD; 200mg CBD/4mg THC) capsules produced by Ecofibre/Ananda Hemp will be used
bsCBD Cannabidiol
DrugBroad spectrum hemp-derived CBD (bsCBD; 200mg CBD) capsules produced by Ecofibre/Ananda Hemp will be used
Placebo
DrugPlacebo arm; capsules produced by Ecofibre/Ananda Hemp will be used
Treatment groups
385 Participants
are divided into 3 treatment groupsGroup A: Full-Spectrum Hemp-Derived CBD (fsCBD)Experimental treatment 1 intervention
Group B: Broad-Spectrum Hemp-Derived CBD (bsCBD)Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Subjective Motor Function
Activities-specific Balance Confidence Scale. Participants asked about confidence in completion of 16 daily tasks without losing balance or becoming unsteady. Responses are on a scale from no confidence to completely confident, with higher aggregate scores meaning higher subjective motor function.
Time frame
Baseline, 4 weeks, 8 weeks2
Balance
Dynamic sway (balance) measured via an app on a standard smartphone which will be attached to the participant's waist using a Velcro strap.
Time frame
Baseline, 4 weeks, 8 weeks3
Anxiety
Beck Anxiety Inventory. 21 question survey. Each question is answered from 0 (not at all) to 3 (severely), where higher scores suggest higher anxiety. Total scores are between 0-63, where anything above 36 suggest potentially concerning levels of anxiety.
Time frame
Baseline, 4 weeks, 8 weeks4
Depression
Beck Depression Inventory. 21 question survey. Each question is answered from 0 (not at all) to 3 (severely), where higher scores suggest higher depression. Total scores are between 0-63, where anything above 40 suggest potentially concerning levels of depression.
Time frame
Baseline, 4 weeks, 8 weeksSecondary outcomes
1
Polypharmacy-Pain Medications
Use of pain medications
Time frame
Baseline, 4 weeks, 8 weeks2
Polypharmacy-Psychiatric Medications
Use of psychiatric medications
Time frame
Baseline, 4 weeks, 8 weeks3
Polypharmacy-Sleep Medications
Use of sleep medications
Time frame
Baseline, 4 weeks, 8 weeks4
Strength and Endurance
Leg strength and endurance measured with 30-second chair stand task. Participants are asked to stand up from a chair as many times as possible for 30 seconds.
Time frame
Baseline, 4 weeks, 8 weeksSponsors and contacts
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Source ClinicalTrials.gov