Aging and Marijuana: Benefits, Effects, and Risks

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cannabis Use Among Older Adults: Potential Risks and Benefits to an Aging Population

Conditions
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Cannabis Use

Intervention / Treatment
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* Behavioral: Choice of cannabis product


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cannabis Users<br>Older adults (60 and up) who report pain, sleep problems, and/or negative mood (anxiety and/or depression) and who desire to use cannabis for these issues (n=300) | Behavioral: Choice of cannabis product<br>* Participants choose and purchase their own cannabis product<br>|
| Cannabis Non-users<br>Older adults (60 and up) who report pain, sleep problems, and/or negative mood (anxiety and/or depression) and do NOT desire to use cannabis for these issues (n=50) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Global Impression of Change | Self report of whether symptoms have improved, gotten worse, or stayed the same | 1-month, 2 months, 3 months, 4 months | 
| Change in FACT-Cog | Self-report of whether cognitive function has improved, gotten worse, or stayed the same | Baseline, 1-month, 2 months, 3 months, 4 months | 
| Change in Rey Auditory Verbal Learning Task | Test of whether working memory has improved, gotten worse, or stayed the same | Baseline, 1-month | 
| Balance Task | Stability with eyes closed and eyes open | 1-month | 
| Change in Activities Specific Balance Confidence Scale | Self-report of whether confidence in balance has improved, gotten worse, or stayed the same | Baseline, 1-month, 2 months, 3 months, 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression Anxiety Stress Scale | Self-report of whether depression, anxiety and stress have improved, gotten worse, or stayed the same | Baseline, 1-month, 2 months, 3 months, 4 months | 
| Change in PROMIS Sleep Disturbance | Self-report of whether sleep quality has improved, gotten worse, or stayed the same | Baseline, 1-month, 2 months, 3 months, 4 months | 
| Change in PROMIS Fatigue | Measure of whether experience of fatigue has improved, gotten worse, or stayed the same | Baseline, 1-month, 2 months, 3 months, 4 months | 
| Change in PROMIS Pain Interference | Self-report of whether the extent to which pain interferes with daily life activities has improved, gotten worse, or stayed the same | Baseline, 1-month, 2 months, 3 months, 4 months | 
| Change in pain Intensity past 7 days | Self-report of whether intensity of pain has improved, gotten worse, or stayed the same | Baseline, 1-month, 2 months, 3 months, 4 months | 
| Current Pain Intensity | Self-reported intensity of pain right now | 1-month | 
| Addiction Research Center Inventory Marijuana Survey | Acute subjective effects of cannabis | 1-month | 
| Drug Effects Questionnaire | Acute subjective effects of cannabis | 1-month | 
| Profile of Mood States | Acute mood effects of cannabis | 1-month | 
| Change in PROMIS Global Health | Self-report of whether general health and functioning has improved, gotten worse, or stayed the same | Baseline, 1-month, 2 months, 3 months, 4 months | 
| Change in Polypharmacy | Measure of whether number and dosage of current medications has improved, gotten worse, or stayed the same | Baseline, 1-month, 2 months, 3 months, 4 months | 
| Change in Online Timeline Follow-back Assessment | 30-day retrospective report of substance use (cannabis, alcohol, other drugs); measure of whether substance use has improved, gotten worse, or stayed the same | Baseline, 1-month, 2 months, 3 months, 4 months | 
| Change in Marijuana Consumption Questionnaire | Self-report of whether frequency and quantity of cannabis use changes over time or stays the same | Baseline, 1-month, 2 months, 3 months, 4 months |