Aging and Marijuana: Benefits, Effects, and Risks
- Conditions
- Cannabis Use
- Interventions
- Behavioral: Choice of cannabis product
- Registration Number
- NCT05188404
- Lead Sponsor
- University of Colorado, Boulder
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cannabis Users Choice of cannabis product 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)
- Primary Outcome Measures
Name Time Method Change in FACT-Cog Baseline, 1-month, 2 months, 3 months, 4 months Self-report of whether cognitive function has improved, gotten worse, or stayed the same
Change in Rey Auditory Verbal Learning Task Baseline, 1-month Test of whether working memory has improved, gotten worse, or stayed the same
Balance Task 1-month Stability with eyes closed and eyes open
Change in Activities Specific Balance Confidence Scale Baseline, 1-month, 2 months, 3 months, 4 months Self-report of whether confidence in balance has improved, gotten worse, or stayed the same
Change in Patient Global Impression of Change 1-month, 2 months, 3 months, 4 months Self report of whether symptoms have improved, gotten worse, or stayed the same
- Secondary Outcome Measures
Name Time Method Change in Depression Anxiety Stress Scale Baseline, 1-month, 2 months, 3 months, 4 months Self-report of whether depression, anxiety and stress have improved, gotten worse, or stayed the same
Change in pain Intensity past 7 days Baseline, 1-month, 2 months, 3 months, 4 months Self-report of whether intensity of pain has improved, gotten worse, or stayed the same
Current Pain Intensity 1-month Self-reported intensity of pain right now
Addiction Research Center Inventory Marijuana Survey 1-month Acute subjective effects of cannabis
Profile of Mood States 1-month Acute mood effects of cannabis
Change in Online Timeline Follow-back Assessment Baseline, 1-month, 2 months, 3 months, 4 months 30-day retrospective report of substance use (cannabis, alcohol, other drugs); measure of whether substance use has improved, gotten worse, or stayed the same
Change in Marijuana Consumption Questionnaire Baseline, 1-month, 2 months, 3 months, 4 months Self-report of whether frequency and quantity of cannabis use changes over time or stays the same
Change in Polypharmacy Baseline, 1-month, 2 months, 3 months, 4 months Measure of whether number and dosage of current medications has improved, gotten worse, or stayed the same
Change in PROMIS Sleep Disturbance Baseline, 1-month, 2 months, 3 months, 4 months Self-report of whether sleep quality has improved, gotten worse, or stayed the same
Change in PROMIS Fatigue Baseline, 1-month, 2 months, 3 months, 4 months Measure of whether experience of fatigue has improved, gotten worse, or stayed the same
Change in PROMIS Pain Interference Baseline, 1-month, 2 months, 3 months, 4 months Self-report of whether the extent to which pain interferes with daily life activities has improved, gotten worse, or stayed the same
Drug Effects Questionnaire 1-month Acute subjective effects of cannabis
Change in PROMIS Global Health Baseline, 1-month, 2 months, 3 months, 4 months Self-report of whether general health and functioning has improved, gotten worse, or stayed the same
Trial Locations
- Locations (1)
University of Colorado Boulder
🇺🇸Boulder, Colorado, United States