Cannabis UseNCT05084105
Cannabis and Aging
An observational study of Cannabis Use, run by Thorsten Rudroff at 1 site in United States.
Trial summary
With increased availability and use of cannabis by older adults aged ≥ 50 years, a rigorous evaluation of the benefits and risks of cannabis use in these individuals is necessary. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 1 Nov 2021
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 30 older (age 50-80 years) men and women who are using cannabis and 30 controls who are non-users, will be recruited.
Who may be able to join
- 50-80 years
- Healthy enough to complete the protocol based on information obtained from a clinical exam and past medical history, such as cardiovascular diseases.
- Comprehension of the protocol as indicated by an ability to respond to questions about the study after reading the consent form.
- Able to use and be contacted by telephone.
- Able to speak, read, and understand English, and complete a questionnaire in English
Who cannot join
- Presence of pacemakers, aneurysm clips, artificial heart valves, metallic prostheses
- Pregnancy
- History of significant traumatic brain injury
- Unable to lie flat for the study imaging
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Health and Human Physiology
Iowa City, Iowa, 52242
About this study
Official title: Cannabis Use and Risk of Falling in Older Adults: an Observation Study
With increased availability and use of cannabis by older adults aged ≥ 50 years, a rigorous evaluation of the benefits and risks of cannabis use in these individuals is necessary. Our proposed project will investigate whether older adults who initiate cannabis use after the age of 50 are at an increased risk of fall and what are the underlying mechanisms. We will measure motor and cognitive function in older cannabis users and nonusers and we will use positron emission tomography to determine brain activity and how it is associated with fall risk.
Read the detailed description
The prevalence of cannabis use has increased significantly in recent years among US adults aged 50 years and older. With increased availability and use of cannabis by older adults, a rigorous evaluation of the benefits and risks of cannabis use in these individuals is necessary. Aging is characterized by physiological and social changes that make older adults vulnerable to chronic disease and geriatric conditions, including cognitive impairment and falls. Unintentional falls are a common event for older adults and a major cause of morbidity and mortality linked with a decline in functional status and disability. Moreover, falls and cognitive impairment are a "well-known couple"; as older adults with moderate to severe cognitive impairment have a higher risk of falls, with an annual incidence of around 60-80%, which is twice the rate of cognitively normal older adults. Impaired cognitive function is an effect of cannabis use, and there is increasing evidence that those effects may persist later in life. Therefore, the physiological effects of chronic cannabis use may further increase falls in older adults via alterations in gait and cognition. Studies have shown reduced neural activity in the frontal brain networks and associations with increased fear of falling in older adults. It is also known that in regular cannabis users, the effects of cannabis may have an impact on cognitive-motor skills and brain mechanisms that modulate coordinated movement. The goal of this application is to investigate the neural correlates of fall risk and cognitive and motor function in individuals who initiate drug use after the age of 50. We will use FDG-PET to determine brain activity. Fall risk and cognitive/motor function will be assessed with the measures from the NIH Toolbox and a fall risk model. Our central hypothesis is that older chronic cannabis users are at a higher fall risk than older non-users, which is associated with reduced cerebral FDG uptake. These results are expected to provide critical and timely data to the public and health professionals regarding the effects of self-directed cannabis use on increased fall risk and if clinicians need to assess cannabis use when determining fall risk and deciding prevention strategies.
- Conditions
- Cannabis Use
- Keywords
- Cannabis, Aging, Falls, Brain Glucose Uptake
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cannabis Group | A total of 30 older (age 50-80 years) men and women who are using cannabis. | |
| Control Group | A total of 30 older (age 50-80 years) men and women who are not using cannabis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall Risk
The following equation for the prediction of falls will be used:
Likelihood of falling (%) = (exp (-7.519 + 0.026(reaction time) - 0.071(ABC1) - 2.139(Berg 14))) / (1 + exp (-7.519 + 0.026(reaction time) - 0.071(ABC1) - 2.139(Berg 14)) ×100)
Measured: Through study completion, on average 1 year
Brain activity PET Imaging
To investigate cerebral glucose uptake in older chronic cannabis users and non-users
Measured: Through study completion, on average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start1 Feb 2020
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thorsten Rudroff
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thorsten Rudroff, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084105
- Sponsor's protocol ID
- 201909808
- Status last verified
- May 2022
- First submitted
- 5 Oct 2021
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabis Use and Risk of Falling in Older Adults: an Observation Study
- ClinicalTrials.gov ID
- NCT05084105
- Acronym / sponsor ID
- 201909808
- Conditions
- Cannabis Use
- Keywords
- Cannabis, Aging, Falls, Brain Glucose Uptake
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Thorsten RudroffUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 19 Oct 2021 (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.
With increased availability and use of cannabis by older adults aged ≥ 50 years, a rigorous evaluation of the benefits and risks of cannabis use in these individuals is necessary. Our proposed project will investigate whether older adults who initiate cannabis use after the age of 50 are at an increased risk of fall and what are the underlying mechanisms. We will measure motor and cognitive function in older cannabis users and nonusers and we will use positron emission tomography to determine brain activity and how it is associated with fall risk.
Detailed description
The prevalence of cannabis use has increased significantly in recent years among US adults aged 50 years and older. With increased availability and use of cannabis by older adults, a rigorous evaluation of the benefits and risks of cannabis use in these individuals is necessary. Aging is characterized by physiological and social changes that make older adults vulnerable to chronic disease and geriatric conditions, including cognitive impairment and falls. Unintentional falls are a common event for older adults and a major cause of morbidity and mortality linked with a decline in functional status and disability. Moreover, falls and cognitive impairment are a "well-known couple"; as older adults with moderate to severe cognitive impairment have a higher risk of falls, with an annual incidence of around 60-80%, which is twice the rate of cognitively normal older adults. Impaired cognitive function is an effect of cannabis use, and there is increasing evidence that those effects may persist later in life. Therefore, the physiological effects of chronic cannabis use may further increase falls in older adults via alterations in gait and cognition. Studies have shown reduced neural activity in the frontal brain networks and associations with increased fear of falling in older adults. It is also known that in regular cannabis users, the effects of cannabis may have an impact on cognitive-motor skills and brain mechanisms that modulate coordinated movement. The goal of this application is to investigate the neural correlates of fall risk and cognitive and motor function in individuals who initiate drug use after the age of 50. We will use FDG-PET to determine brain activity. Fall risk and cognitive/motor function will be assessed with the measures from the NIH Toolbox and a fall risk model. Our central hypothesis is that older chronic cannabis users are at a higher fall risk than older non-users, which is associated with reduced cerebral FDG uptake. These results are expected to provide critical and timely data to the public and health professionals regarding the effects of self-directed cannabis use on increased fall risk and if clinicians need to assess cannabis use when determining fall risk and deciding prevention strategies.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabis Group | – | –A total of 30 older (age 50-80 years) men and women who are using cannabis. |
| Control Group | – | –A total of 30 older (age 50-80 years) men and women who are not using cannabis. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 30 older (age 50-80 years) men and women who are using cannabis and 30 controls who are non-users, will be recruited.
Key inclusion criteria (5 listed)
- 50-80 years
- Healthy enough to complete the protocol based on information obtained from a clinical exam and past medical history, such as cardiovascular diseases.
- Comprehension of the protocol as indicated by an ability to respond to questions about the study after reading the consent form.
- Able to use and be contacted by telephone.
- Able to speak, read, and understand English, and complete a questionnaire in English
Key exclusion criteria (4 listed)
- Presence of pacemakers, aneurysm clips, artificial heart valves, metallic prostheses
- Pregnancy
- History of significant traumatic brain injury
- Unable to lie flat for the study imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fall Risk
Time frame: Through study completion, on average 1 year
The following equation for the prediction of falls will be used: Likelihood of falling (%) = (exp (-7.519 + 0.026(reaction time) - 0.071(ABC1) - 2.139(Berg 14))) / (1 + exp (-7.519 + 0.026(reaction time) - 0.071(ABC1) - 2.139(Berg 14)) ×100)
Brain activity PET Imaging
Time frame: Through study completion, on average 1 year
To investigate cerebral glucose uptake in older chronic cannabis users and non-users
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 24 May 2022.
- 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 Thorsten Rudroff 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 5 inclusion and 4 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 24 May 2022. 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?
Fall Risk (time frame: Through study completion, on average 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2022; AzTrials last refreshed its copy on 29 Oct 2026.