Developing a Mobile Method to Measure THC-induced Impairment

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.

Official Title
-----------------
A Mobile Prototype for a Field Sobriety Test for Cannabis

Conditions
-----------------
Measuring THC-induced Cognitive Impairment Using a Mobile Application

Intervention / Treatment
-----------------
* Drug: Dronabinol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-35 years old, males and females (N=44; 36 completers; 18 men, 18 women) BMI 19-26 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 PTSD ADHD Cardiovascular illness, high blood pressure, abnormal EKG Current medications Pregnant or planning to become pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|
| Active Comparator: 7.5 mg THC<br> | Drug: Dronabinol<br>* 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).<br>|
| Active Comparator: 15 mg THC<br> | Drug: Dronabinol<br>* 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).<br>|

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 |