We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05188404
Recruitment Status : Recruiting
First Posted : January 12, 2022
Last Update Posted : July 18, 2022
Sponsor:
Information provided by (Responsible Party):
Angela Bryan, 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.

Condition or disease Intervention/treatment
Cannabis Use 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cannabis Use Among Older Adults: Potential Risks and Benefits to an Aging Population
Actual Study Start Date : September 20, 2021
Estimated Primary Completion Date : January 31, 2026
Estimated Study Completion Date : January 31, 2026

Resource links provided by the National Library of Medicine


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)



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05188404


Locations
Layout table for location information
United States, Colorado
University of Colorado Boulder Recruiting
Boulder, Colorado, United States, 80309
Contact: Angela D Bryan, PhD    303-588-3335    angela.bryan@colorado.edu   
Sponsors and Collaborators
University of Colorado, Boulder
Layout table for additonal information
Responsible Party: Angela Bryan, Professor, University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT05188404    
Other Study ID Numbers: 1R01AG066698 ( U.S. NIH Grant/Contract )
First Posted: January 12, 2022    Key Record Dates
Last Update Posted: July 18, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders