Clinical trial NCT06290063: Cannabidiol and Older Adult Cannabis Users
Official title: Rocky Mountain Cannabis Research Center - Cannabidiol and Older Adult Cannabis Users: A Randomized, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Sleep
Anxiety
Depression
Pain
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 385
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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)

Primary outcomes:
measure: Subjective Motor Function
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Balance
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Anxiety
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Depression
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Blood Cytokine Levels
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Depression/Anxiety
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Drug Effects
timeFrame: 4 weeks, 8 weeks
measure: Inhibitory Control
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Cognitive Function
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Pain Intensity and Interference
timeFrame: Baseline, 4 Weeks, 8 Weeks
measure: Cognitive Ability
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Pain Intensity
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change in Condition
timeFrame: 4 weeks, 8 weeks
measure: Sleep Disturbance
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Sleep-Related Impairment
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Memory
timeFrame: Baseline, 4 weeks, 8 weeks
Secondary outcomes:
measure: Polypharmacy-Pain Medications
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Polypharmacy-Psychiatric Medications
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Polypharmacy-Sleep Medications
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Strength and Endurance
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Sleep Quality
timeFrame: Baseline, 4 weeks, 8 weeks
Other outcomes:
Locations:
city: Boulder
country: United States
facility: University of Colorado at Boulder
state: Colorado
Study officials:
References: