At a glance
ClinicalIndex Comparison Record- ✓Age 50 years or older
- ✓Severe and/or chronic pain
- ✓Newly registered to Florida Medical Marijuana Use Registry (intervention group)
- ✓No prior history of medical marijuana use (intervention group)
- ✕Lacks fluency in English
- ✕Unable to provide informed consent due to cognitive impairment
- ✕Unwilling to provide information for follow-up
- ✕Plans to leave area within 3 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Medical Marijuana Use and Driving Performance: A Test of Psychomotor Function in Adults 50 and Older
In Brief
An observational study evaluating Medical Cannabis for Chronic Pain. Completed, enrolled 44 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Medical marijuana is defined by Florida state statue 381.986 as all parts of any plant of the genus Cannabis, whether growing or not; the seeds thereof; the resin extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant or its seeds or resin, including low-THC cannabis, which are dispensed from a medical marijuana treatment center for medical use by a qualified patient.