N/A
N=44
Reactions of Older Adults Driving After Cannabis Exposure
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT04629716 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Simulated Driving Performance Task Measuring Divided Attention — 3.42; 2.57 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Medical Cannabis (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Florida State University
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Simulated Driving Performance Task Measuring Divided Attention |
3.42; 2.57 | — |
| SECONDARY Unwanted Effects of Marijuana Use |
1; 0 | — |
Summary
Objective of the Protocol: The primary aim of the current protocol is to examine whether or not habitual use of medical marijuana affects psychomotor functioning operationalized as driving performance. Secondary endpoints will examine whether type of medical marijuana used, frequency, dosage or route of administration is associated with Unwanted effects. The proposed study is a prospective repeated measures experimental study designed to test medical marijuana use as the exposure variable in adults age 50 and older and driving errors in response time, attention, and executive functions as the primary outcome. Secondary outcomes include: Unwanted effects. Participants will complete 3 assessments over a 3 month time period. The 3 assessment time points are: baseline (T1), prior to starting medical marijuana, 1 month post-medical marijuana initiation (T2), and 3 months post-medical marijuana initiation (T3). Electronic Medical Review (EMR) will be conducted at baseline, 1, and 3 months. In addition, potentially confounding disease, treatment, and sociodemographic characteristics will be examined. Data will be collected in a manner that is consistent with transparent reporting as mandated by CONSORT guidelines. Finite mixture modeling and generalized linear modeling accounting for individual and group level outcomes will be used to test the study hypotheses. The investigators propose to enroll 60 adults (n=30 medical marijuana users and n=30 age, race, sex matched controls) ages 50 and older with chronic/severe non-malignant pain, which is the most common diagnosis for medical marijuana users. Primary Endpoint: Thus, the proposed study will test medical marijuana use as the exposure variable in adults age 50 and older and simulated driving performance (e.g. errors in response time, attention, and executive functioning tasks that predict on-road performance) as the primary outcome. Secondary Endpoint: Further, the investigators will explore the association between medical marijuana use and Unwanted effects.
Eligibility Criteria
Inclusion Criteria
- Participant is aged 50 or older
- Participant reports severe and/or chronic pain
- Participant is newly registered to the Medical Marijuana Use Registry in Florida (intervention group only)
- Participant has no prior history with medical marijuana use (intervention group only)
Exclusion Criteria
- Participant lacks fluency in English
- Participant is unwilling to provide information for follow-up
- Participant plans to leave the area within 3 months
- Participant is unable to provide informed consent due to cognitive impairment
- Participant is unwilling to complete necessary study procedures
Data sourced from ClinicalTrials.gov (NCT04629716). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.