Reactions of Older Adults Driving After Cannabis Exposure

NCT04629716 | Completed Results

• 1 other identifier: STUDY00001659
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain

Keywords

medical marijuana; older adults; chronic pain

Outcome Measures

Primary Outcomes (1)

• Simulated Driving Performance Task Measuring Divided Attention

  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 indicating poor divided attention (worse outcome) such that all divided attention tasks presented in the simulator was missed and 4 indicating good divided attention (better outcome) such that all divided attention tasks presented in the simulator were completed. Therefore, a higher score indicates better divided attention such that participants attended to more events while driving in the simulator.

  1 month

Secondary Outcomes (1)

• Unwanted Effects of Marijuana Use

  1 month

Study Arms (2)

Intervention

The intervention group will be comprised of adults 50 and older who report severe or chronic pain, are newly registered for the Medical Marijuana Registry in the State of Florida, have no prior history of medical marijuana use, can communicate in English, and are willing and able to complete study procedures. The control group will be age, sex, and race matched. The primary study outcome is simulated driving performance (i.e. errors in response time, attention, and executive functioning tasks that predict on-road performance). Secondary outcomes include adverse effects.

Other: Medical Cannabis

Control

The control group will be comprised of adults 50 and older who report severe or chronic pain, have no prior history of medical marijuana use, can communicate in English, and are willing and able to complete study procedures. The control group will be age, sex, and race matched. The primary study outcome is simulated driving performance (i.e. errors in response time, attention, and executive functioning tasks that predict on-road performance). Secondary outcomes include adverse effects.

Interventions

Medical Cannabis OTHER

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.

Also known as: Medical Marijuana

Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The investigators will recruit 30 patients from Medical Marijuana Treatment Clinics (MMTC) of Gainesville. The intervention group will be comprised of adults 50 and older who report severe or chronic pain, are newly registered for the Medical Marijuana Registry in the State of Florida, have no prior history of medical marijuana use, can communicate in English, and are willing and able to complete study procedures. The control group will be age, sex, and race matched.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Smart House at Oak Hammock

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Medical Marijuana

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Results Point of Contact

• Title: Nicole Ennis, PhD
• Organization: Florida State University

nicole.ennis@med.fsu.edu

850-644-2334

Study Officials

• Nicole Ennis, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 16, 2020
• Study Start: April 23, 2021
• Primary Completion: August 17, 2023
• Study Completion: August 31, 2023
• Last Updated: March 24, 2025
• Results First Posted: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available six months after Aim 1 and Aim 2 papers have been published
• Access Criteria: available to users under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Locations

US (1)