NCT03804840: AIS

Developing a Mobile Method to Measure THC-induced Impairment

Completed EARLY_PHASE1 Results posted Last updated 19 September 2024

What this trial tests

EARLY_PHASE1 trial testing Dronabinol in Measuring THC-induced Cognitive Impairment Using a Mobile Application in 72 participants. Completed in 1 December 2018.

Timeline

1 March 2017

Primary endpoint
1 December 2018

1 December 2018

Quick facts

Lead sponsor	University of Chicago
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	quadruple
Primary purpose	basic science
Enrollment	72
Start date	1 March 2017
Primary completion	1 December 2018
Estimated completion	1 December 2018
Sites	1 location across United States

Drugs / interventions tested

• Dronabinol (DRONABINOL) — full drug profile →
• Placebo

Conditions studied

• Measuring THC-induced Cognitive Impairment Using a Mobile Application — all drugs for Measuring THC-induced Cognitive Impairment Using a Mobile Application →

Sponsor

University of Chicago

Who can join

Adults 18 to 35, any sex, with Measuring THC-induced Cognitive Impairment Using a Mobile Application. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Simple Reaction Time Primary · 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

Group	Value	95% CI
Placebo	.365	± .07
7.5 mg THC	.386	± .09
15 mg THC	.396	± .10

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The landscape of decentralized clinical trials (DCTs): focusing on the FDA and EMA guidance.
   Park J, Huh KY, Chung WK, Yu KS. · · 2024 · cited 11× · PMID 38586122 · DOI 10.12793/tcp.2024.32.e2