Early Phase 1
N=72
Developing a Mobile Method to Measure THC-induced Impairment
Measuring THC-induced Cognitive Impairment Using a Mobile Application
Bottom Line
View on ClinicalTrials.gov: NCT03804840 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Simple Reaction Time — .365; .386; .396 Seconds
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Dronabinol (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Simple Reaction Time |
.365; .386; .396 | — |
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.
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
- Post Traumatic Stress Disorder
- Attention Deficit Hyperactivity Disorder
- Cardiovascular illness, high blood pressure, abnormal EKG
- Current medications
- Pregnant or planning to become pregnant
Data sourced from ClinicalTrials.gov (NCT03804840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.