Effects of THC and Alcohol on Driving Performance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-31

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Low blood concentrations of THC and alcohol appear to have a minimal effect on driving performance.However, there is a gap in the literature about the combined effects of THC and alcohol. There is little empirical evidence to determine whether the combination of THC and alcohol could be additive or multiplicative. This issue is particularly important when dealing with concentrations that are just below legal thresholds - it is important to identify if someone who may have consumed cannabis and alcohol, in quantities that do not exceed legal thresholds, may nonetheless be impaired to drive. Answering this question requires more research on the combined effects of THC and alcohol under tightly controlled experimental conditions. Hence, the purpose of this study is to determine the additive (or multiplicative) effect of standardized low doses of cannabis, in combination with low-doses of alcohol, on a number of outcome measures related to driving. The investigators will focus specifically on the effect of low blood concentrations of THC (0, 125, and 250 µg/kg) alone and in combination with low blood concentrations of alcohol (BAC 0%, .025%, and .049%). They shall determine the combined effect of THC and alcohol on physiological, cognitive, subjective measures of impairment, and simulated driving. This study will focus on younger adults because they have higher impaired driving rates than other age groups. As a secondary aim of the study, the investigators will examine whether previous driving and drug use history are correlated with driving decisions during the simulated drive and subjective measures. This study will contribute to the evidence base informing legislation, policy making, and law enforcement. This study is particularly timely given upcoming changes in legislation about cannabis, and because the combination of THC and alcohol, even below legal thresholds, may lead to impaired driving and crashes.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Combined Alcohol and Cannabis Effects on Skills of Young Drivers

NCT03106363

Psychomotor Impairment

COMPLETED EARLY_PHASE1

Effects of Cannabis/Alcohol on Driving Performance and Field Sobriety Tests

NCT05273658

Driving Impaired Alcohol Intoxication Driving Under the Influence +1 more

WITHDRAWN PHASE1/PHASE2

Alcohol Effects on Driving-related Skills of Young Drivers

NCT02710578

Psychomotor Impairment

COMPLETED NA

Marijuana Effects on Simulated Driving Performance

NCT03699540

Cannabis Cannabis Use Marijuana +2 more

COMPLETED PHASE1

Effects of Inhaled Cannabis on Driving Performance

NCT01620177

Alcohol Drinking Cannabis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cannabis Alcohol Drinking Accident, Traffic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

THC 0

THC dose = 0mg

Intervention Type DRUG

THC 5

THC dose = 5mg

Intervention Type DRUG

THC 10

THC dose = 10mg

Intervention Type DRUG

BAC 0

Blood alcohol concentration = .000%

Intervention Type OTHER

BAC .025

Blood alcohol concentration = .025%

Intervention Type OTHER

BAC .049

Blood alcohol concentration = .049%

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tetrahydrocannabinol Dronabinol Cannabis Tetrahydrocannabinol Dronabinol Cannabis Tetrahydrocannabinol Dronabinol Cannabis

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* BMI \>18 and \<30
* valid G2 or G Ontario driver's license
* live on-campus or within 15 minutes drive of campus
* speak fluent English

Exclusion Criteria

* history of cardiovascular or psychiatric disorders
* current use of psychoactive medication
* current drug or alcohol abuse problem
* positive drug screen
* BAC level \> .000%

Minimum Eligible Age

19 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes