Medical Marijuana and Open Road Driving Task
ConditionMedical Cannabis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorFlorida State University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 population
Adults in the state of Florida aged 50 and older
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
250 Participants
are grouped into 2 trial groupsGroup A: Medical Marijuana Use (MMG)
Group B: No Marijuana Exposure (NMG)
Trial outcomes
Primary outcomes
1
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).
Time frame
One DaySponsors and contacts
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Florida State University
Lead sponsor
University of Florida
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov