Effects of Inhaled Cannabis on Driving Performance

NCT01620177 | Completed Results DMC

• 1 other identifier: 201109850
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to expand understanding of the effects of cannabis on driving performance with and without the presence of low levels of alcohol. This project will involve the development a of a protocol and driving environment that is sensitive to the effects of cannabis on driving performance by building on prior driving situations used previously for testing the effects of alcohol on driving.

Conditions

Alcohol Drinking; Cannabis

Keywords

Cannabis; Marijuana; Marihuana; Alcohol; Driving

Outcome Measures

Primary Outcomes (1)

• Driving Performance

  Measured by standard deviation of lane position. Metrics of driving performance were modeled using the SAS GLM Select function to identify changes in driver performance. Numbers represents coefficients on the regression equation such that this increase would be expected for every unit increase. A unit for THC is 1 ng/ml and a unit for BAC is 0.01% BAC. In understanding the regression coefficients, for THC the units for the coefficient would be expressed as cm per (ng/ml of THC), and for BrAC the units for the coefficient would be expressed as cm per (0.01% BrAC). The overall regression equation would be represented as SDLP = Intercept + Cthc x THC + Cbrac x BrAC. The coefficients indicate the strength of the effect on driving performance with higher coefficients indicating larger effects relative to the concentrations. Coefficients of zero indicate no effect or interactive effect.

  Through entire drive, 0.5-1.3 hr post cannabis administration.

Secondary Outcomes (2)

• THC Concentration in Plasma Sample

  -0.7 hr, 0.25hr, 1.1 hr, 2 hr, 3 hr, 4.5 hr, 6 hr, 8 hr post cannabis administration

• THC Concentration Levels in Whole Blood

  -0.7 hr, 0.25hr, 1.1 hr, 2 hr, 3 hr, 4.5 hr, 6 hr, 8 hr post cannabis

Study Arms (6)

0% THC with 0.065 g/dL BAC

EXPERIMENTAL

Drug: Alcohol(oral) and placebo; Drug: Cannabis(THC)(Inhaled) and Placebo

2.5-3.5% THC with 0.065 g/dL BAC

EXPERIMENTAL

Drug: Alcohol(oral) and placebo; Drug: Cannabis(THC)(Inhaled) and Placebo

6.0-7.5% THC and 0.065 g/dL BAC

EXPERIMENTAL

Drug: Alcohol(oral) and placebo; Drug: Cannabis(THC)(Inhaled) and Placebo

2.5-3.5% THC with 0 g/dL BAC

EXPERIMENTAL

Drug: Alcohol(oral) and placebo; Drug: Cannabis(THC)(Inhaled) and Placebo

6.0-7.5% THC with 0 g/dL BAC

EXPERIMENTAL

Drug: Alcohol(oral) and placebo; Drug: Cannabis(THC)(Inhaled) and Placebo

0% THC with 0 g/dL BAC

EXPERIMENTAL

Drug: Alcohol(oral) and placebo; Drug: Cannabis(THC)(Inhaled) and Placebo

Interventions

Alcohol(oral) and placebo DRUG

Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive

Also known as: Ethanol, Ethyl Alcohol

0% THC with 0 g/dL BAC; 0% THC with 0.065 g/dL BAC; 2.5-3.5% THC with 0 g/dL BAC; 2.5-3.5% THC with 0.065 g/dL BAC; 6.0-7.5% THC and 0.065 g/dL BAC; 6.0-7.5% THC with 0 g/dL BAC

Cannabis(THC)(Inhaled) and Placebo DRUG

Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC

Also known as: Marihuana, Marijuana

0% THC with 0 g/dL BAC; 0% THC with 0.065 g/dL BAC; 2.5-3.5% THC with 0 g/dL BAC; 2.5-3.5% THC with 0.065 g/dL BAC; 6.0-7.5% THC and 0.065 g/dL BAC; 6.0-7.5% THC with 0 g/dL BAC

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult (age 21-55) men and women, based on medical and psychological evaluation
• Currently valid unrestricted (except for vision correction) US driver's license
• Licensed driver for at least the past two years
• Drove at least 1300 miles in the past year, by self-report
• Live within an 80 mile radius of NADS
• Available for an overnight stay followed by a full-day study session for six sessions
• Must be considered a light or moderate drinker according to Quantity-Frequency-Variability Scale (QFV)
• Cannabis use with a minimum frequency averaging at least one day per quarter and no more than three days a week during the three months prior to study entry
• Peripheral veins suitable for repeated venipuncture and/or placement of an intravenous catheter
• Systolic blood pressure within a clinically normal range (120 ± 30 mmHg) and -diastolic blood pressure of 80 ± 20 mmHg..
• Good command of written and spoken English
• Female subjects with reproductive potential must agree to use (and/or have their partner use) one (1) acceptable method of birth control beginning at the screening visit throughout the study (including intervals between treatment periods/panels) and until 2 weeks after the last dose of study drug in the last treatment period. Acceptable methods of birth control include the following: intrauterine device (IUD-with or without local hormone release), diaphragm, spermicides, cervical cap, contraceptive sponge, oral contraceptives or condoms. Abstinence is an alternative lifestyle and subjects practicing abstinence may be included in the study.

You may not qualify if:

• Presence of any clinically significant illness, as detected by history, physical examination, and/or laboratory tests, that might influence driving performance (e.g., seizures, sleep apnea, narcolepsy, vertigo, chronic fatigue syndrome) or put the subject at increased risk of adverse events (e.g., cardiac arrhythmia, hypertension)
• History of a clinically significant adverse event associated with cannabis or alcohol intoxication
• Donation of more than 450 mL of blood within 14 days of study drug administration
• If female, pregnant or nursing
• Currently interested in or participating in drug abuse treatment, or participated in drug abuse treatment within 60 days preceding study enrollment
• Currently taking drugs that are contraindicated for use with study drugs
• Requires any special equipment to aid in driving (ex. pedal extensions, hand brake or throttle, spinner wheel knobs or other non-standard equipment)
• Significant history of motion sickness or demonstrates significant simulator sickness during practice drives at screening (SSQ). Subjects must have scores below the following values on the SSQ: Nausea \< 21, Oculomotor \<32, Disorientation \< 15, and Total Score \< 32.
• Current alcohol or cannabis use disorder, as identified by the Alcohol Use Disorders Identification Test for alcohol or Cannabis Use Disorders Identification Test for cannabis.
• History of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject from study participation
• Prior participation in a driver impairment or distraction-related research study conducted at NADS that uses the same base drive.

Sponsors & Collaborators

• Gary R Gaffney: lead
• National Highway Traffic Safety Administration (NHTSA): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

National Advanced Driving Simulator

Iowa City, Iowa, 52242, United States

Location

Related Publications (4)

• Hartman RL, Brown TL, Milavetz G, Spurgin A, Pierce RS, Gorelick DA, Gaffney G, Huestis MA. Cannabis effects on driving lateral control with and without alcohol. Drug Alcohol Depend. 2015 Sep 1;154:25-37. doi: 10.1016/j.drugalcdep.2015.06.015. Epub 2015 Jun 23.

  PMID: 26144593 RESULT

• Hartman RL, Brown TL, Milavetz G, Spurgin A, Gorelick DA, Gaffney G, Huestis MA. Controlled Cannabis Vaporizer Administration: Blood and Plasma Cannabinoids with and without Alcohol. Clin Chem. 2015 Jun;61(6):850-69. doi: 10.1373/clinchem.2015.238287. Epub 2015 May 27.

  PMID: 26019183 RESULT

• Hartman RL, Brown TL, Milavetz G, Spurgin A, Gorelick DA, Gaffney G, Huestis MA. Controlled vaporized cannabis, with and without alcohol: subjective effects and oral fluid-blood cannabinoid relationships. Drug Test Anal. 2016 Jul;8(7):690-701. doi: 10.1002/dta.1839. Epub 2015 Aug 10.

  PMID: 26257143 RESULT

• Hartman RL, Brown TL, Milavetz G, Spurgin A, Pierce RS, Gorelick DA, Gaffney G, Huestis MA. Cannabis effects on driving longitudinal control with and without alcohol. J Appl Toxicol. 2016 Nov;36(11):1418-29. doi: 10.1002/jat.3295. Epub 2016 Feb 18.

  PMID: 26889769 RESULT

MeSH Terms

Conditions

Alcohol Drinking; Marijuana Abuse

Interventions

Ethanol; nabiximols

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Limitations and Caveats

This study examined only occasional users and the generalization to new or frequent cannabis users is unclear.

Results Point of Contact

• Title: Dr. Timothy L. Brown, Co-PI
• Organization: National Advanced Driving Simulator

timothy-l-brown@uiowa.edu

319-335-4785

Study Officials

• Gary G Gaffney, M.D.

  National Advanced Driving Simulator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, College of Medicine

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: June 15, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 2, 2018
• Results First Posted: June 1, 2017

Record last verified: 2018-04

Locations

US (1)