Effects of THC and Alcohol on Driving Performance

NCT03555968 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 2018502
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cannabis; Alcohol Drinking; Accident, Traffic

Keywords

THC; Alcohol; Driving; Dronabinol

Outcome Measures

Primary Outcomes (1)

• Demerit Points on Simulated Road Test

  Demerit points incurred for driving errors during a simulated a G2 exit exam (the final step in Ontario's graduated licensing framework) on a STISIM Drive 3-screen driving simulator; demerit points will be assigned in real-time by a member of the research team based on the Ontario Ministry of Transportation scoring scheme

  @2.5 hours

Secondary Outcomes (9)

• Standard Deviation of Lane Position in Meters (STISIM Drive-Recorded Variable)

  @2.5 hours

• Mean and Standard Deviation of Velocity in Meters/Second (STISIM Drive-Recorded Variable)

  @2.5 hours

• Mean and Standard Deviation of Acceleration in Meters/Second (STISIM Drive-Recorded Variable)

  @2.5 hours

• Blood Pressure (Systolic/Diastolic mmHg)

  @25 minutes and 2 hours

• Heart Rate (BPM) & Heart Rate Variability via ECG

  Hour 0-3.5

Study Arms (9)

THC 0 + BAC 0

PLACEBO COMPARATOR

Participants will receive 0mg of THC in combination with blood alcohol concentrations of .000%.

Drug: THC 0; Other: BAC 0

THC 5 + BAC 0

EXPERIMENTAL

Participants will receive 5mg of THC in combination with blood alcohol concentrations of .000%.

Drug: THC 5; Other: BAC 0

THC 10 + BAC 0

EXPERIMENTAL

Participants will receive 10mg of THC in combination with blood alcohol concentrations of .000%.

Drug: THC 10; Other: BAC 0

THC 5 + BAC .025

EXPERIMENTAL

Participants will receive 5mg of THC in combination with blood alcohol concentrations of .025%.

Drug: THC 5; Other: BAC .025

THC 10 + BAC .025

EXPERIMENTAL

Participants will receive 125 µg/kg of THC in combination with blood alcohol concentrations of .025%.

Drug: THC 5; Other: BAC .025

THC 0 + BAC .049

EXPERIMENTAL

Participants will receive 0 µg/kg of THC in combination with blood alcohol concentrations of .049%.

Drug: THC 0; Drug: THC 10; Other: BAC .025; Other: BAC .049

THC 5 + BAC .049

EXPERIMENTAL

Participants will receive 5mg of THC in combination with blood alcohol concentrations of .049%.

Drug: THC 5; Other: BAC .049

THC 10 + BAC .049

EXPERIMENTAL

Participants will receive 10mg of THC in combination with blood alcohol concentrations of .049%.

Drug: THC 5; Other: BAC .049

THC 0 + BAC .025

EXPERIMENTAL

Participants will receive 0 µg/kg of THC in combination with blood alcohol concentrations of .025%.

Drug: THC 0; Drug: THC 10; Other: BAC .025; Other: BAC .049

Interventions

THC 0 DRUG

THC dose = 0mg

Also known as: Tetrahydrocannabinol, Dronabinol, Cannabis

THC 0 + BAC .025; THC 0 + BAC .049; THC 0 + BAC 0

THC 5 DRUG

THC dose = 5mg

Also known as: Tetrahydrocannabinol, Dronabinol, Cannabis

THC 10 + BAC .025; THC 10 + BAC .049; THC 5 + BAC .025; THC 5 + BAC .049; THC 5 + BAC 0

THC 10 DRUG

THC dose = 10mg

Also known as: Tetrahydrocannabinol, Dronabinol, Cannabis

THC 0 + BAC .025; THC 0 + BAC .049; THC 10 + BAC 0

BAC 0 OTHER

Blood alcohol concentration = .000%

THC 0 + BAC 0; THC 10 + BAC 0; THC 5 + BAC 0

BAC .025 OTHER

Blood alcohol concentration = .025%

THC 0 + BAC .025; THC 0 + BAC .049; THC 10 + BAC .025; THC 5 + BAC .025

BAC .049 OTHER

Blood alcohol concentration = .049%

THC 0 + BAC .025; THC 0 + BAC .049; THC 10 + BAC .049; THC 5 + BAC .049

Eligibility Criteria

• Age: 19 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lakehead University: lead

MeSH Terms

Conditions

Marijuana Abuse; Alcohol Drinking

Interventions

Dronabinol; nabiximols; THC 5

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Michel Bédard, PhD

  Lakehead University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 14, 2018
• Study Start: July 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share