- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01620177
Effects of Inhaled Cannabis on Driving Performance
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- National Advanced Driving Simulator
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 0% THC with 0.065 g/dL BAC
|
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
Other Names:
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
Other Names:
|
Experimental: 2.5-3.5% THC with 0.065 g/dL BAC
|
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
Other Names:
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
Other Names:
|
Experimental: 6.0-7.5% THC and 0.065 g/dL BAC
|
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
Other Names:
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
Other Names:
|
Experimental: 2.5-3.5% THC with 0 g/dL BAC
|
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
Other Names:
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
Other Names:
|
Experimental: 6.0-7.5% THC with 0 g/dL BAC
|
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
Other Names:
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
Other Names:
|
Experimental: 0% THC with 0 g/dL BAC
|
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
Other Names:
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Driving Performance
Time Frame: Through entire drive, 0.5-1.3 hr post cannabis administration.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
THC Concentration in Plasma Sample
Time Frame: -0.7 hr, 0.25hr, 1.1 hr, 2 hr, 3 hr, 4.5 hr, 6 hr, 8 hr post cannabis administration
|
Measurement of THC concentration levels in plasma over the course of each visit compared to that of the other visits.
|
-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
Time Frame: -0.7 hr, 0.25hr, 1.1 hr, 2 hr, 3 hr, 4.5 hr, 6 hr, 8 hr post cannabis
|
Measurement of THC concentration levels in whole blood over the course of each visit compared to that of the other visits.
|
-0.7 hr, 0.25hr, 1.1 hr, 2 hr, 3 hr, 4.5 hr, 6 hr, 8 hr post cannabis
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gary G Gaffney, M.D., National Advanced Driving Simulator
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201109850
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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