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

June 17, 2025 updated by: Angela Bryan, University of Colorado, Boulder

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
326

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1-month, 2 months, 3 months, 4 months
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
Baseline, 1-month, 2 months, 3 months, 4 months
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
Baseline, 1-month
Balance Task
Time Frame: 1-month
Stability with eyes closed and eyes open
1-month
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
Baseline, 1-month, 2 months, 3 months, 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline, 1-month, 2 months, 3 months, 4 months
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
Baseline, 1-month, 2 months, 3 months, 4 months
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
Baseline, 1-month, 2 months, 3 months, 4 months
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
Baseline, 1-month, 2 months, 3 months, 4 months
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
Baseline, 1-month, 2 months, 3 months, 4 months
Current Pain Intensity
Time Frame: 1-month
Self-reported intensity of pain right now
1-month
Addiction Research Center Inventory Marijuana Survey
Time Frame: 1-month
Acute subjective effects of cannabis
1-month
Drug Effects Questionnaire
Time Frame: 1-month
Acute subjective effects of cannabis
1-month
Profile of Mood States
Time Frame: 1-month
Acute mood effects of cannabis
1-month
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
Baseline, 1-month, 2 months, 3 months, 4 months
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
Baseline, 1-month, 2 months, 3 months, 4 months
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
Baseline, 1-month, 2 months, 3 months, 4 months
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
Baseline, 1-month, 2 months, 3 months, 4 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline, 1-month
Change in Neurofilament Light
Time Frame: Baseline, 1-month
Quantitation of neuronal damage in blood; measure of whether damage change over time
Baseline, 1-month
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
Baseline, 1-month, 2 months, 3 months, 4 months
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
Baseline, 1-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Boulder

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 25, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings