Effects of Inhaled Cannabis on Driving Performance

NCT01620177 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2018-05-02

Study results available
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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

Interventions

DRUG

Alcohol(oral) and placebo

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

DRUG

Cannabis(THC)(Inhaled) and Placebo

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

Sponsors & Collaborators

  • National Highway Traffic Safety Administration (NHTSA)

    collaborator FED
  • National Institute on Drug Abuse (NIDA)

    collaborator NIH
  • Gary R Gaffney

    lead OTHER

Principal Investigators

  • Gary G Gaffney, M.D. · National Advanced Driving Simulator

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01620177 on ClinicalTrials.gov