Medical Marijuana and Open Road Driving Task

NCT ID: NCT06995937

Last Updated: 2025-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-19

Study Completion Date

2029-01-30

Brief Summary

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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.

Detailed Description

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Conditions

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Medical Cannabis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Medical Marijuana Use (MMG)

Individuals aged 50 and older who report medical marijuana use \>12 months daily or most days of the week

No interventions assigned to this group

No Marijuana Exposure (NMG)

Individuals aged 50 and older who report no marijuana exposure past 10 years (race-sex matched to MMG group).

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Florida State University

OTHER

Sponsor Role lead

Responsible Party

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Nicole Ennis

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Florida

Gainesville, Florida, United States

Site Status RECRUITING

Florida State University, Center for Translational Behavioral Science

Tallahassee, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nicole Ennis, PhD

Role: CONTACT

850-644-2334

Sara Green, MSW

Role: CONTACT

850-644-2334

Facility Contacts

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Sherrilene Classen, PhD

Role: primary

352-273-6883

Nicole Ennis, PhD

Role: primary

850-644-2334

Sara Green, MSW

Role: backup

850-644-2334

Other Identifiers

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1R01DA057965

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00005560

Identifier Type: -

Identifier Source: org_study_id

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