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NCT Number: NCT06995937

Medical Marijuana and Open Road Driving Task

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.

Recruiting

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Key information

Conditions

Medical Cannabis

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida, Gainesville, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Nicole Ennis, PhD

CONTACT

[email protected]

850-644-2334

Sara Green, MSW

CONTACT

[email protected]

850-644-2334

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • University of Florida

Registry information

Official study title

An Open Road Driving Performance Task to Examine Long-term Medical Marijuana Use and Prescription Opioid Positivity in Adults 50 and Older

Acronym: ROADACE

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
May 30, 2025
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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