NCT04629716: ROADACE

Reactions of Older Adults Driving After Cannabis Exposure

Completed Results posted Last updated 24 March 2025

What this trial tests

trial testing Medical Cannabis in Chronic Pain in 44 participants. Completed in 31 August 2023.

Timeline

23 April 2021

Primary endpoint
17 August 2023

31 August 2023

Quick facts

Lead sponsor	Florida State University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	44
Start date	23 April 2021
Primary completion	17 August 2023
Estimated completion	31 August 2023
Sites	1 location across United States

Drugs / interventions tested

• Medical Cannabis — full drug profile →

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →

Sponsor

Florida State University

Who can join

50 and older, any sex, with Chronic Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Simulated Driving Performance Task Measuring Divided Attention Primary · 1 month

Studies of driving performance using driving simulators have been shown to be a valid predictor of on-road driving performance. Driving simulators allow for the systematic presentation of events and the manipulation of variables, which offers experimental control that is impossible on the road. Driving simulators also offer optimal stimulus presentation which allows for analysis of both healthy and impaired drivers under similar conditions. There was a total of 4 divided attention task events presented during the course of the simulated drive. Therefore, scores ranged from 0-4, with 0 indicati

Group	Value	95% CI
Intervention	3.42	± 0.67
Control	2.57	± 0.98

Unwanted Effects of Marijuana Use Secondary · 1 month

In this study, adverse effects are defined as undesired effects that occur when the medication is administered. The investigators will use Scripted Prompting, a proactive form of adverse effect capture recognized in the field. This method is designed to elicit adverse effects without biasing the patient; it is a standardized question that allows participant to report important symptoms without being influenced by suggestion. For this study, the investigators will ask: "Since initiating medical marijuana, are you having any problems related to use?"

Group	Value	95% CI
Intervention	1
Control	0

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Medical Marijuana Initiation and Simulated Driving Performance Among Mid-to-Late-Life Adults With Chronic Pain: Prospective Observational Feasibility Cohort Study With Matched Controls.
   Ennis N, Hou Y, Kloss K, Rogers J, et al · · 2026 · PMID 42102282 · DOI 10.2196/79735