Phase 1
N=10
Marijuana Effects on Simulated Driving Performance
Cannabis · Cannabis Use · Marijuana · Marijuana Usage · Alcohol Drinking
Bottom Line
View on ClinicalTrials.gov: NCT03699540 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Mean Peak for Standard Deviation in Lane Position (SDLP) — 1.33; 1.37; 1.42; 1.35 centimeters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Marijuana (Drug); Alcohol (Drug); placebo alcohol (Drug); Inactive marijuana (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Shanna Babalonis, PhD
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Peak for Standard Deviation in Lane Position (SDLP) |
1.33; 1.37; 1.42; 1.35; 1.77 | — |
| SECONDARY Subject-Rated Outcomes: Mean Peak Score for Driving Difficulty |
6.75; 33.89; 40.89; 30.22; 71.89 | — |
| SECONDARY Subject-Rated Outcome: Mean Peak Score for Drug and Alcohol Effect |
6.13; 32.11; 68.89; 38.44; 71.22 | — |
| SECONDARY Subject-Rated Outcome: Mean Peak Score for Difficulty Concentrating |
0.38; 1.11; 2.22; 0.78; 3.89 | — |
| SECONDARY Observer-Rated Outcome: Mean Peak Score for Relaxed |
1.50; 1.67; 2.00; 2.11; 2.11 | — |
| SECONDARY Observer-Rated Outcome: Mean Peak Score for Good Mood |
1.25; 1.44; 1.78; 1.89; 2.11 | — |
Summary
This study will examine the effects of various strains of marijuana on simulated driving performance; the effects of alcohol administration will also be examined to further understand how marijuana-induced driving changes compare to the effects of alcohol. Secondary outcomes will include physiological effects, subjective- and observer-rated outcomes, and psychomotor performance under the various dose conditions.
Eligibility Criteria
Inclusion Criteria
- Healthy, adult participants
- Ages 21-50
- History of marijuana use
- History of alcohol use
Exclusion Criteria
- Clinically significant medical conditions
- Ongoing/significant drug use outside of marijuana and alcohol use
Data sourced from ClinicalTrials.gov (NCT03699540). 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.