Aging and Marijuana: Benefits, Effects, and Risks (AMBER)

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

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.

Study Overview

• Status: Completed
• Conditions: Cannabis Use
• Intervention / Treatment: Behavioral: Choice of cannabis product

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.

• Study Type: Observational
• Enrollment (Actual): 326

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80309
      • University of Colorado Boulder

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Participants choose and purchase their own 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)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Blood Cannabinoids and Endocannabinoids	Quantitation of major and minor cannabinoids and endocannabinoids in blood; measure of whether cannabinoid levels change over time	Baseline, 1-month
Change in Neurofilament Light	Quantitation of neuronal damage in blood; measure of whether damage change over time	Baseline, 1-month
Change in Expectancies about Cannabis	Self-report of whether opinions about the health effects of cannabis has improved, gotten worse, or stayed the same	Baseline, 1-month, 2 months, 3 months, 4 months
Change in Flanker Inhibitory Control and Attention task	Measure of whether inhibition has improved, gotten worse, or stayed the same	Baseline, 1-month

Collaborators and Investigators

• Sponsor: University of Colorado, Boulder

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Actual): May 25, 2025
• Study Completion (Actual): May 25, 2025

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: December 27, 2021
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Marijuana Abuse
• Other Study ID Numbers: 1R01AG066698 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No