Aging and Marijuana: Benefits, Effects, and Risks

NCT05188404 | Completed

• 1 other identifier: 1R01AG066698
• Study Type: observational
• Target: 326
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Use

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (13)

• Change in Depression Anxiety Stress Scale

  Baseline, 1-month, 2 months, 3 months, 4 months

• Change in PROMIS Sleep Disturbance

  Baseline, 1-month, 2 months, 3 months, 4 months

• Change in PROMIS Fatigue

  Baseline, 1-month, 2 months, 3 months, 4 months

• Change in PROMIS Pain Interference

  Baseline, 1-month, 2 months, 3 months, 4 months

• Change in pain Intensity past 7 days

  Baseline, 1-month, 2 months, 3 months, 4 months

Other Outcomes (4)

• Change in Blood Cannabinoids and Endocannabinoids

  Baseline, 1-month

• Change in Neurofilament Light

  Baseline, 1-month

• Change in Expectancies about Cannabis

  Baseline, 1-month, 2 months, 3 months, 4 months

Study Arms (2)

Cannabis Users

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

Cannabis Non-users

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)

Interventions

Choice of cannabis product BEHAVIORAL

Participants choose and purchase their own cannabis product

Cannabis Users

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Boulder: lead

Study Sites (1)

University of Colorado Boulder

Boulder, Colorado, 80309, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: January 12, 2022
• Study Start: September 20, 2021
• Primary Completion: May 25, 2025
• Study Completion: May 25, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)