Examine the Feasibility of a Standardized Field Test for Marijuana Impairment: Laboratory Evaluations

Summary

Marijuana is one of the most widely used substances. This study will characterize the persistence of cannabis' (CNB's) acute effects on cognitive test performance and simulated driving over a several hour time period. The data obtained from simulated driving, cognitive tests, and biological assays of THC will be used in analyses aimed at identifying what tests or combination of tests predict both recent use and driving impairment risk.

Eligible participants will undergo a full day screening visit, if still eligible they will come to Hartford Hospital in Hartford, Connecticut to take part in the full study. Participation requires overnight stays between each of the five study visits. On each of the study days participants are dosed with either a low dose of THC marijuana, a high dose of THC marijuana or placebo marijuana, (the low and high doses are repeated once each, order in which the study drug is given is double blind and chosen at random.)

Conditions

• Marijuana Impairment

Interventions

DRUG

Low Dose THC Marijuana

Dosing via vaporized marijuana using a lower concentration of THC, participants receive this dose on two of the five study visits.

DRUG

High Dose THC Marijuana

Dosing via vaporized marijuana using a higher concentration of THC, participants receive this dose on two of the five study visits.

DRUG

Placebo Marijuana

Dosing via vaporized marijuana with no THC, participants receive this dose on one of the five study visits.

Sponsors & Collaborators

• National Highway Traffic Safety Administration (NHTSA)

  collaborator FED

• Hartford Hospital

  collaborator OTHER

• Montana State University

  collaborator OTHER

• Maastricht University

  collaborator OTHER

• The Mind Research Network

  collaborator OTHER

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Yale University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

SINGLE_GROUP

Eligibility

Min Age

20 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-12-01

Primary Completion

2020-03-30

Completion

2020-03-30

FDA Drug

Yes

Countries

• United States

Study Locations