Trial Outcomes & Findings for Reactions of Older Adults Driving After Cannabis Exposure (NCT NCT04629716)
NCT ID: NCT04629716
Last Updated: 2025-03-24
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
44 participants
Primary outcome timeframe
1 month
Results posted on
2025-03-24
Participant Flow
Participant milestones
| Measure |
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.
Medical Cannabis: 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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
21
|
|
Overall Study
Timepoint 2
|
19
|
19
|
|
Overall Study
COMPLETED
|
16
|
18
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
| Measure |
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.
Medical Cannabis: 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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
3
|
Baseline Characteristics
Reactions of Older Adults Driving After Cannabis Exposure
Baseline characteristics by cohort
| Measure |
Intervention
n=23 Participants
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.
Medical Cannabis: 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.
|
Control
n=21 Participants
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.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Continuous
|
61.48 years
STANDARD_DEVIATION 6.42 • n=5 Participants
|
64.24 years
STANDARD_DEVIATION 6.68 • n=7 Participants
|
62.80 years
STANDARD_DEVIATION 6.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
21 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Center for Epidemiologic Studies Depression ScaleCES-D
|
16.3 units on a scale
STANDARD_DEVIATION 10.23 • n=5 Participants
|
8.38 units on a scale
STANDARD_DEVIATION 6.06 • n=7 Participants
|
12.52 units on a scale
STANDARD_DEVIATION 9.31 • n=5 Participants
|
|
Mini-Mental State Examination-2; Brief Version (MMSE-2;BV)
|
15.17 units on a scale
STANDARD_DEVIATION 1.15 • n=5 Participants
|
15.43 units on a scale
STANDARD_DEVIATION 0.60 • n=7 Participants
|
15.30 units on a scale
STANDARD_DEVIATION 0.93 • n=5 Participants
|
|
Education
Less than H.S.
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Education
H.S. or GED equivalent
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Education
Post H.S. education
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Income
Less than 30K USD annual
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Income
30,001-60,000 USD annual
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Income
60,001 and greater USD annual
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Primary outcome was analyzed at T2 and each group lost a few participants to follow-up.
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.
Outcome measures
| Measure |
Intervention
n=19 Participants
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.
Medical Cannabis: 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.
|
Control
n=19 Participants
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.
|
|---|---|---|
|
Simulated Driving Performance Task Measuring Divided Attention
|
3.42 units on a scale
Standard Deviation 0.67
|
2.57 units on a scale
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Data available at T2 due to lost to follow up
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?"
Outcome measures
| Measure |
Intervention
n=19 Participants
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.
Medical Cannabis: 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.
|
Control
n=19 Participants
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.
|
|---|---|---|
|
Unwanted Effects of Marijuana Use
|
1 Participants
|
0 Participants
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place