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Developing a Mobile Method to Measure THC-induced Impairment

NCT03804840 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-09-19

Study results available
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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

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

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Elisa Pabon · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2018-12-01
Completion
2018-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03804840 on ClinicalTrials.gov