Clinical trial NCT05188404: Aging and Marijuana: Benefits, Effects, and Risks
Official title: Cannabis Use Among Older Adults: Potential Risks and Benefits to an Aging Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cannabis Use
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 326
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older adults experiencing problems with pain, sleep, depression or anxiety who either wish to use cannabis or who do not wish to cannabis

Brief summary: Investigators will gather data on both the beneficial and harmful effects of edible cannabis of varying composition (THC-only vs. CBD-only vs. THC+CBD), and will examine the process by which older adult cannabis users decide what type of cannabis product is preferred.

Detailed description: Older adults are currently the fastest growing group of cannabis users in the U.S, and are more likely to use cannabis for medicinal purposes (e.g., pain, trouble sleeping, depression/anxiety) than for recreational purposes, despite having little data to guide their decisions about what type of product to use. This project utilizes a patient-centered observational design to recruit and assess older adults who are interested in using cannabis compared to a control group who is not interested in cannabis use. Investigators will gather data on both the beneficial and harmful effects of edible cannabis of varying composition (THC-only vs. CBD-only vs. THC+CBD), and will examine the process by which older adult cannabis users decide what type of cannabis product is preferred.

Eligibility criteria: Inclusion Criteria:

* At least 60 years of age
* Able to provide informed consent
* Cannabis Users: Must not currently use cannabis more than 7 times per month and not for pain, sleep, depression or anxiety in the past 6 months
* Cannabis Non-users: Should NOT have used cannabis in the past year and have not used regularly (e.g., more than weekly) for more than one year in the past 20 years
* Cannabis Users: Must be interested in using cannabis for at least one of the following complains: pain, sleep problems, depression, anxiety
* Non-users: Must NOT be interested in using cannabis but have at least one of the following complaints: pain, sleep problems, depression, anxiety
* Cannabis users: must be comfortable using edible cannabis and having a mobile laboratory (Dodge van) parked at their home
* Female participants must be postmenopausal
* Comfortable reading and writing in English
* Planning to stay in the Boulder/Denver area for the next month
* Must be comfortable with blood draws

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 of psychosis
* Current use of antipsychotic medications
* Heavy drinking; Alcohol Use Disorder Identification Test (AUDIT) test score \>8
* Inability/discomfort/unwillingness with getting in and out of the mobile laboratory van
* History of vertigo or falls within the past six months

Primary outcomes:
measure: Change in Patient Global Impression of Change
timeFrame: 1-month, 2 months, 3 months, 4 months
measure: Change in FACT-Cog
timeFrame: Baseline, 1-month, 2 months, 3 months, 4 months
measure: Change in Rey Auditory Verbal Learning Task
timeFrame: Baseline, 1-month
measure: Balance Task
timeFrame: 1-month
measure: Change in Activities Specific Balance Confidence Scale
timeFrame: Baseline, 1-month, 2 months, 3 months, 4 months
Secondary outcomes:
measure: Change in Depression Anxiety Stress Scale
timeFrame: Baseline, 1-month, 2 months, 3 months, 4 months
measure: Change in PROMIS Sleep Disturbance
timeFrame: Baseline, 1-month, 2 months, 3 months, 4 months
measure: Change in PROMIS Fatigue
timeFrame: Baseline, 1-month, 2 months, 3 months, 4 months
measure: Change in PROMIS Pain Interference
timeFrame: Baseline, 1-month, 2 months, 3 months, 4 months
measure: Change in pain Intensity past 7 days
timeFrame: Baseline, 1-month, 2 months, 3 months, 4 months
measure: Current Pain Intensity
timeFrame: 1-month
measure: Addiction Research Center Inventory Marijuana Survey
timeFrame: 1-month
measure: Drug Effects Questionnaire
timeFrame: 1-month
measure: Profile of Mood States
timeFrame: 1-month
measure: Change in PROMIS Global Health
timeFrame: Baseline, 1-month, 2 months, 3 months, 4 months
measure: Change in Polypharmacy
timeFrame: Baseline, 1-month, 2 months, 3 months, 4 months
measure: Change in Online Timeline Follow-back Assessment
timeFrame: Baseline, 1-month, 2 months, 3 months, 4 months
measure: Change in Marijuana Consumption Questionnaire
timeFrame: Baseline, 1-month, 2 months, 3 months, 4 months
Other outcomes:
measure: Change in Blood Cannabinoids and Endocannabinoids
timeFrame: Baseline, 1-month
measure: Change in Neurofilament Light
timeFrame: Baseline, 1-month
measure: Change in Expectancies about Cannabis
timeFrame: Baseline, 1-month, 2 months, 3 months, 4 months
measure: Change in Flanker Inhibitory Control and Attention task
timeFrame: Baseline, 1-month
Locations:
city: Boulder
country: United States
facility: University of Colorado Boulder
state: Colorado
Study officials:
References: