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NCT04629716 · ClinicalTrials.gov registry record
Reactions of Older Adults Driving After Cannabis Exposure
A clinical trial, sponsored by Florida State University.
- Completed
- Registry status
- 44
- Enrollment target
NCT04629716 is a clinical trial that has completed, run by Florida State University. The registered enrollment target is 44 participants.
The verdict
NCT04629716 has completed, sponsored by Florida State University.
- COMPLETED
- Registry status
- 44 participants
- Enrollment target
Study 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 medica
Interventions
- OTHER Medical Cannabis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2021-04-23 |
| Est. Completion | 2023-08-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04629716
The ClinicalTrials.gov registry entry for NCT04629716 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Florida State University, which has 219 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Medical Cannabis is the first listed.
NCT04629716 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04629716 about?
NCT04629716 is a clinical study titled "Reactions of Older Adults Driving After Cannabis Exposure". 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 rout...
What is the current status of trial NCT04629716?
This trial is currently completed. The enrollment target is 44 participants. The study started on 2021-04-23. Estimated completion is 2023-08-31.
What interventions are being tested in trial NCT04629716?
The interventions under investigation include: Medical Cannabis (OTHER).
Who is sponsoring clinical trial NCT04629716?
This trial is sponsored by Florida State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
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