Clinical trial NCT03699540: Marijuana Effects on Simulated Driving Performance
Official title: Marijuana Effects on Simulated Driving Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cannabis
Cannabis Use
Marijuana
Marijuana Usage
Alcohol Drinking
Keywords: simulated driving, outpatient
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-10-09
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Within-subject, randomized, placebo-controlled, double-dummy, double-blind study
Primary purpose: BASIC_SCIENCE

Brief 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

Primary outcomes:
measure: Mean Peak for Standard Deviation in Lane Position (SDLP)
timeFrame: This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals.
Secondary outcomes:
measure: Subject-Rated Outcomes: Mean Peak Score for Driving Difficulty
timeFrame: This outcome (VAS score) was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals.
measure: Subject-Rated Outcome: Mean Peak Score for Drug and Alcohol Effect
timeFrame: This outcome (VAS scores) was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 9 hrs)
measure: Subject-Rated Outcome: Mean Peak Score for Difficulty Concentrating
timeFrame: This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals.
measure: Observer-Rated Outcome: Mean Peak Score for Relaxed
timeFrame: This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals.
measure: Observer-Rated Outcome: Mean Peak Score for Good Mood
timeFrame: This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals.
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
References: