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Clinical Trials/NCT03804840
NCT03804840
Completed
Early Phase 1

A Mobile Prototype for a Field Sobriety Test for Cannabis

University of Chicago1 site in 1 country48 target enrollmentMarch 1, 2017

Overview

Phase
Early Phase 1
Intervention
Placebo
Conditions
Measuring THC-induced Cognitive Impairment Using a Mobile Application
Sponsor
University of Chicago
Enrollment
48
Locations
1
Primary Endpoint
Simple Reaction Time
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Marijuana use, for both recreational and therapeutic purposes, is becoming increasingly common as states remove restrictions on use. The increased use raises new concern about the safety of this drug, including its ability to impair basic cognitive and psychomotor tasks, and whether the users are aware of their impairment. We propose to design a simple performance test that users can use in the field, using a cell phone, to assess their level of impairment relative to their own drug-free state. In this preliminary study, we will compare participants' simple task performance after a known dose of delta-9-tetrahydrocannabinol (THC), or placebo, administered under double-blind conditions. In our app the participants will be asked to gauge their own perceived level of impairment (as determined by self-ratings and judgments of impairment) as well as their actual impairment (as gauged by the app), providing important feedback and training about their ability to detect impairment.

Registry
clinicaltrials.gov
Start Date
March 1, 2017
End Date
December 1, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 18-35 years old, males and females (N=44; 36 completers; 18 men, 18 women)
  • High school education, fluent in English
  • Experienced non-daily marijuana users

Exclusion Criteria

  • Current drug/alcohol abuse or dependence
  • Past year drug/alcohol dependence
  • Diagnosis with drug treatment for psychosis/bipolar/schizophrenia
  • Past year major depression
  • Panic/anxiety attacks in past 2 months
  • Cardiovascular illness, high blood pressure, abnormal EKG
  • Current medications
  • Pregnant or planning to become pregnant

Arms & Interventions

Placebo

Intervention: Placebo

7.5 mg THC

Intervention: Dronabinol

15 mg THC

Intervention: Dronabinol

Outcomes

Primary Outcomes

Simple Reaction Time

Time Frame: Assessed two hour post intervention at peak effects

In this reaction time task, the user is asked to shake the device in response to a visual clue on the device's screen. The user makes three attempts, in which he or she must shake or move the device with an acceleration that is greater than the value of the thresholdAcceleration property within the given time. The task finishes when the user successfully completes the attempts as instructed in the task. Data collected by this task is in the form of ORKReactionTimeResult objects. Each of these objects contain a timestamp representing the delivery of the stimulus and an ORKFileResult object that references the motion data collected during an attempt.

Study Sites (1)

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