Cannabis UseAMBERNCT05188404
Aging and Marijuana: Benefits, Effects, and Risks
An observational study of Cannabis Use, run by University of Colorado, Boulder at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use
- What is being tested?
- Choice of cannabis product
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 326 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2021to 25 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Boulder
Boulder, Colorado, 80309
About this study
Official title: 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.
Read the 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.
- Conditions
- Cannabis Use
- Being tested
- Choice of cannabis product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choice of cannabis productBehavioural
Participants choose and purchase their own cannabis product
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Global Impression of Change
Self report of whether symptoms have improved, gotten worse, or stayed the same
Measured: 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
Measured: 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
Measured: Baseline, 1-month
Balance Task
Stability with eyes closed and eyes open
Measured: 1-month
Change in Activities Specific Balance Confidence Scale
Self-report of whether confidence in balance has improved, gotten worse, or stayed the same
Measured: Baseline, 1-month, 2 months, 3 months, 4 months
Secondary outcomes (13)
Change in Depression Anxiety Stress Scale
Self-report of whether depression, anxiety and stress have improved, gotten worse, or stayed the same
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 1-month, 2 months, 3 months, 4 months
Current Pain Intensity
Self-reported intensity of pain right now
Measured: 1-month
Addiction Research Center Inventory Marijuana Survey
Acute subjective effects of cannabis
Measured: 1-month
Drug Effects Questionnaire
Acute subjective effects of cannabis
Measured: 1-month
Profile of Mood States
Acute mood effects of cannabis
Measured: 1-month
Change in PROMIS Global Health
Self-report of whether general health and functioning has improved, gotten worse, or stayed the same
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 1-month, 2 months, 3 months, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start20 Sep 2021
- Primary completion25 May 2025
- Study completion25 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Bryan, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188404
- Sponsor's protocol ID
- 1R01AG066698
- Acronym
- AMBER
- Status last verified
- Jun 2025
- First submitted
- 10 Dec 2021
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sundali E, Lisano JK, Bryan AD, Skrzynski CJ. Heart rate response to cannabis in active older adults. Eur J Appl Physiol. 2026 Jun;126(6):3315-3321. doi: 10.1007/s00421-026-06152-6. Epub 2026 Feb 12.
PubMed 41677842
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabis Use Among Older Adults: Potential Risks and Benefits to an Aging Population
- ClinicalTrials.gov ID
- NCT05188404
- Acronym / sponsor ID
- AMBER / 1R01AG066698
- Conditions
- Cannabis Use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 25 May 2025 (actual)
- Study completion
- 25 May 2025 (actual)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabis Users | – | Behavioral: Choice of cannabis productOlder 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) |
| 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) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Choice of cannabis productParticipants choose and purchase their own cannabis product | Behavioural | Cannabis Users |
Primary outcome
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
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
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
Balance Task
Time frame: 1-month
Stability with eyes closed and eyes open
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
13 secondary outcomes
Change in Depression Anxiety Stress Scale
Time frame: 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
Change in PROMIS Fatigue
Time frame: 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
Change in pain Intensity past 7 days
Time frame: Baseline, 1-month, 2 months, 3 months, 4 months
Current Pain Intensity
Time frame: 1-month
Addiction Research Center Inventory Marijuana Survey
Time frame: 1-month
Drug Effects Questionnaire
Time frame: 1-month
Profile of Mood States
Time frame: 1-month
Change in PROMIS Global Health
Time frame: Baseline, 1-month, 2 months, 3 months, 4 months
Change in Polypharmacy
Time frame: 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
Change in Marijuana Consumption Questionnaire
Time frame: Baseline, 1-month, 2 months, 3 months, 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Derived from this study: PubMed 41677842Sundali E, Lisano JK, Bryan AD, Skrzynski CJ. Heart rate response to cannabis in active older adults. Eur J Appl Physiol. 2026 Jun;126(6):3315-3321. doi: 10.1007/s00421-026-06152-6. Epub 2026 Feb 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cannabis Use, run by University of Colorado, Boulder at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Global Impression of Change (time frame: 1-month, 2 months, 3 months, 4 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05188404, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025; AzTrials last refreshed its copy on 3 Nov 2026.