NCT03804840

Developing a Mobile Method to Measure THC-induced Impairment

A Mobile Prototype for a Field Sobriety Test for Cannabis

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Measuring THC-induced Cognitive Impairment Using a Mobile Application

Interventions

Type	Name	Description
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.
DRUG	Placebo	Placebo

Timeline

• Start date: 2017-03-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2019-01-15
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study