Developing a Mobile Method to Measure THC-induced Impairment (AIS)

A Mobile Prototype for a Field Sobriety Test for Cannabis

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 Overview

• Status: Completed
• Conditions: Measuring THC-induced Cognitive Impairment Using a Mobile Application
• Intervention / Treatment: Drug: Placebo; Drug: Dronabinol

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60615
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18-35 years old, males and females (N=44; 36 completers; 18 men, 18 women)
2. BMI 19-26
3. High school education, fluent in English

4. Experienced non-daily marijuana users

   Exclusion Criteria:

5. Current drug/alcohol abuse or dependence
6. Past year drug/alcohol dependence
7. Diagnosis with drug treatment for psychosis/bipolar/schizophrenia
8. Past year major depression
9. Panic/anxiety attacks in past 2 months
10. PTSD
11. ADHD
12. Cardiovascular illness, high blood pressure, abnormal EKG
13. Current medications
14. Pregnant or planning to become pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Active Comparator: 7.5 mg THC	Drug: Dronabinol; THC (Marinol® [dronabinol]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication (Broyd et al, 2016; Hartman and Huestis, 2013).
Active Comparator: 15 mg THC	Drug: Dronabinol; THC (Marinol® [dronabinol]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication (Broyd et al, 2016; Hartman and Huestis, 2013).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Simple Reaction Time	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.	Assessed two hour post intervention at peak effects

Collaborators and Investigators

• Sponsor: University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Psychotropic Drugs; Hallucinogens; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Dronabinol
• Other Study ID Numbers: AIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No