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OpenTrials
Completed

NCT Number: NCT05188404

Aging and Marijuana: Benefits, Effects, and Risks

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.

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Key information

Conditions

Cannabis Use

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Boulder

Boulder, Colorado, 80309, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Choice of cannabis product

Behavioral

Participants choose and purchase their own cannabis product

Primary outcomes

  1. Change in Patient Global Impression of Change

    Time frame: 1-month, 2 months, 3 months, 4 months

    Self report of whether symptoms have improved, gotten worse, or stayed the same

  2. Change in FACT-Cog

    Time frame: Baseline, 1-month, 2 months, 3 months, 4 months

    Self-report of whether cognitive function has improved, gotten worse, or stayed the same

  3. Change in Rey Auditory Verbal Learning Task

    Time frame: Baseline, 1-month

    Test of whether working memory has improved, gotten worse, or stayed the same

  4. Balance Task

    Time frame: 1-month

    Stability with eyes closed and eyes open

  5. Change in Activities Specific Balance Confidence Scale

    Time frame: Baseline, 1-month, 2 months, 3 months, 4 months

    Self-report of whether confidence in balance has improved, gotten worse, or stayed the same

Secondary outcomes

  1. Change in Depression Anxiety Stress Scale

    Time frame: 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

  2. Change in PROMIS Sleep Disturbance

    Time frame: Baseline, 1-month, 2 months, 3 months, 4 months

    Self-report of whether sleep quality has improved, gotten worse, or stayed the same

  3. Change in PROMIS Fatigue

    Time frame: Baseline, 1-month, 2 months, 3 months, 4 months

    Measure of whether experience of fatigue has improved, gotten worse, or stayed the same

  4. Change in PROMIS Pain Interference

    Time frame: 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

  5. Change in pain Intensity past 7 days

    Time frame: Baseline, 1-month, 2 months, 3 months, 4 months

    Self-report of whether intensity of pain has improved, gotten worse, or stayed the same

  6. Current Pain Intensity

    Time frame: 1-month

    Self-reported intensity of pain right now

  7. Addiction Research Center Inventory Marijuana Survey

    Time frame: 1-month

    Acute subjective effects of cannabis

  8. Drug Effects Questionnaire

    Time frame: 1-month

    Acute subjective effects of cannabis

  9. Profile of Mood States

    Time frame: 1-month

    Acute mood effects of cannabis

  10. Change in PROMIS Global Health

    Time frame: 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

  11. Change in Polypharmacy

    Time frame: 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

  12. Change in Online Timeline Follow-back Assessment

    Time frame: 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

  13. Change in Marijuana Consumption Questionnaire

    Time frame: 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

Other outcomes

  1. Change in Blood Cannabinoids and Endocannabinoids

    Time frame: Baseline, 1-month

    Quantitation of major and minor cannabinoids and endocannabinoids in blood; measure of whether cannabinoid levels change over time

  2. Change in Neurofilament Light

    Time frame: Baseline, 1-month

    Quantitation of neuronal damage in blood; measure of whether damage change over time

  3. Change in Expectancies about Cannabis

    Time frame: Baseline, 1-month, 2 months, 3 months, 4 months

    Self-report of whether opinions about the health effects of cannabis has improved, gotten worse, or stayed the same

  4. Change in Flanker Inhibitory Control and Attention task

    Time frame: Baseline, 1-month

    Measure of whether inhibition has improved, gotten worse, or stayed the same

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Registry information

Official study title

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

Acronym: AMBER

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 12, 2022
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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