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Clinical Trials/NCT03804840
NCT03804840CompletedEarly Phase 1

A Mobile Prototype for a Field Sobriety Test for Cannabis

University of Chicago1 site in 1 country48 target enrollmentStarted: March 1, 2017Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Early Phase 1
Status
Completed
Enrollment
48
Locations
1
Primary Endpoint
Simple Reaction Time

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Placebo Comparator

Intervention: Placebo (Drug)

7.5 mg THC

Active Comparator

Intervention: Dronabinol (Drug)

15 mg THC

Active Comparator

Intervention: Dronabinol (Drug)

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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