Medical CannabisROADACENCT06995937
Medical Marijuana and Open Road Driving Task
An observational study of Medical Cannabis, run by Florida State University at 2 sites in United States.
Trial summary
Medical marijuana use among adults 50 and older has more than doubled in the past decade with exponential increases projected in this demographic by 2050, and prescription opioids are one of the most common treatments for pain management in this population. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medical Cannabis
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 May 2025to 30 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults in the state of Florida aged 50 and older
Who may be able to join
- Age 50 and older who endorse chronic or severe non-malignant pain
- Resident of Florida with an active and valid Florida Drivers License
- Can communicate in English
- Willing and able to complete study procedures
- Have active medical marijuana card for >12 months issued by the state of Florida (MMG group) OR are race-sex match who has not used marijuana in the past 10 years with no history of daily use (NMG group)
Who cannot join
- Have active psychosis
- Have lost or revoked driving privileges
- Score of below the cut 24 (out of 30) on the Montreal Cognitive Assessment (MoCA)
- Are a control participant who urine test positive for marijuana use and/or reports any marijuana use in past 10 years
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32611
Hongwu Wang, PhD, 352-273-9934, hongwu.wang@ufl.edu
Hongwu Wang, PhD
- Recruiting
Florida State University, Center for Translational Behavioral Science
Tallahassee, Florida, 32310
Nicole Ennis, PhD, 850-274-4032, nennis@fsu.edu
Sara Green, MSW, 850-644-2334, sshaw@fsu.edu
About this study
Official title: An Open Road Driving Performance Task to Examine Long-term Medical Marijuana Use and Prescription Opioid Positivity in Adults 50 and Older
Medical marijuana use among adults 50 and older has more than doubled in the past decade with exponential increases projected in this demographic by 2050, and prescription opioids are one of the most common treatments for pain management in this population. To date, no studies systematically assess driving performance in a rigorous and ecologically valid manner accounting for long-term medical marijuana use and/or the combined effect of prescription opioid use in adults 50 and older who endorse chronic or severe non-malignant pain. Further, studies examining how older adults self-regulate prescription medication use and driving behavior is limited, with none rigorously examining medical marijuana.
- Conditions
- Medical Cannabis
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 |
|---|---|---|
| Medical Marijuana Use (MMG) | Individuals aged 50 and older who report medical marijuana use >12 months daily or most days of the week | |
| No Marijuana Exposure (NMG) | Individuals aged 50 and older who report no marijuana exposure past 10 years (race-sex matched to MMG group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of Maneuvers Score (SMS)
A standardized score sheet with a total of 49 driving maneuvers and eight types of possible driving errors is used by the Certified Driver Rehabilitation Specialist while the participant is driving. The driving errors are lane maintenance errors, speed regulation errors, adjustment-to-stimuli errors, yielding errors, signaling errors, vehicle positioning errors, visual scanning, and gap acceptance errors. For each maneuver, a maximum score of 3 is given if no errors are committed. At the end of the driving course, the sum of the points attained is computed as the sum of maneuvers score (SMS) ranging from 0 to 147, with 147 indicating a perfect driving score (zero errors).
Measured: One Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start19 May 2025
- Primary completion30 Jan 2029 (estimated)
- Study completion30 Jan 2029 (estimated)
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 Medical CannabisStudies 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
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Nicole Ennis, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995937
- Sponsor's protocol ID
- STUDY00005560
- Other IDs
- 1R01DA057965
- Acronym
- ROADACE
- Status last verified
- Aug 2026
- First submitted
- 21 May 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ennis N, Classen S. An Open-Road Driving Performance Task to Examine Long-Term Medical Marijuana Use and Prescription Opioid Positivity Among Adults Aged 50 Years and Older: Protocol for an Observational Trial. JMIR Res Protoc. 2025 Nov 28;14:e77944. doi: 10.2196/77944.
PubMed 41313623
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Road Driving Performance Task to Examine Long-term Medical Marijuana Use and Prescription Opioid Positivity in Adults 50 and Older
- ClinicalTrials.gov ID
- NCT06995937
- Acronym / sponsor ID
- ROADACE / STUDY00005560
- Conditions
- Medical Cannabis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- University of Florida, National Institute on Drug Abuse (NIDA)
- Study start
- 19 May 2025 (actual)
- Primary completion
- 30 Jan 2029 (estimated)
- Study completion
- 30 Jan 2029 (estimated)
- First posted
- 30 May 2025 (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.
Medical marijuana use among adults 50 and older has more than doubled in the past decade with exponential increases projected in this demographic by 2050, and prescription opioids are one of the most common treatments for pain management in this population. To date, no studies systematically assess driving performance in a rigorous and ecologically valid manner accounting for long-term medical marijuana use and/or the combined effect of prescription opioid use in adults 50 and older who endorse chronic or severe non-malignant pain. Further, studies examining how older adults self-regulate prescription medication use and driving behavior is limited, with none rigorously examining medical marijuana.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Marijuana Use (MMG) | – | –Individuals aged 50 and older who report medical marijuana use >12 months daily or most days of the week |
| No Marijuana Exposure (NMG) | – | –Individuals aged 50 and older who report no marijuana exposure past 10 years (race-sex matched to MMG group). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults in the state of Florida aged 50 and older
Key inclusion criteria (5 listed)
- Age 50 and older who endorse chronic or severe non-malignant pain
- Resident of Florida with an active and valid Florida Drivers License
- Can communicate in English
- Willing and able to complete study procedures
- Have active medical marijuana card for >12 months issued by the state of Florida (MMG group) OR are race-sex match who has not used marijuana in the past 10 years with no history of daily use (NMG group)
Key exclusion criteria (4 listed)
- Have active psychosis
- Have lost or revoked driving privileges
- Score of below the cut 24 (out of 30) on the Montreal Cognitive Assessment (MoCA)
- Are a control participant who urine test positive for marijuana use and/or reports any marijuana use in past 10 years
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
Sum of Maneuvers Score (SMS)
Time frame: One Day
A standardized score sheet with a total of 49 driving maneuvers and eight types of possible driving errors is used by the Certified Driver Rehabilitation Specialist while the participant is driving. The driving errors are lane maintenance errors, speed regulation errors, adjustment-to-stimuli errors, yielding errors, signaling errors, vehicle positioning errors, visual scanning, and gap acceptance errors. For each maneuver, a maximum score of 3 is given if no errors are committed. At the end of the driving course, the sum of the points attained is computed as the sum of maneuvers score (SMS) ranging from 0 to 147, with 147 indicating a perfect driving score (zero errors).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Derived from this study: PubMed 41313623Ennis N, Classen S. An Open-Road Driving Performance Task to Examine Long-Term Medical Marijuana Use and Prescription Opioid Positivity Among Adults Aged 50 Years and Older: Protocol for an Observational Trial. JMIR Res Protoc. 2025 Nov 28;14:e77944. doi: 10.2196/77944.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medical Cannabis, run by Florida State University at 2 sites 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: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Ennis, PhD (850-274-4032, nennis@fsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sum of Maneuvers Score (SMS) (time frame: One Day). 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 NCT06995937, 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 20 Aug 2026.