Marijuana Effects on Simulated Driving Performance

Phase 1

Completed

• Conditions: Marijuana Usage; Alcohol Drinking; Cannabis; Cannabis Use; Marijuana
• Interventions: Drug: Inactive marijuana; Drug: placebo alcohol; Drug: Alcohol; Drug: Marijuana

• Registration Number: NCT03699540
• Lead Sponsor: Shanna Babalonis, PhD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-02
• Study First Submitted QC: 2018-10-05
• Study First Posted: 2018-10-09
• Study Start: 2019-07-01
• Primary Completion: 2022-12-01
• Study Completion: 2023-01-01
• Disposition First Submitted: 2023-11-01
• Disposition First Posted: 2023-12-08
• Results First Submitted: 2024-04-30
• Results First Submitted QC: 2024-06-10
• Status Verified: 2024-07
• Results First Posted: 2024-07-03
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Inactive Marijuana Dose	Inactive marijuana	Participants will receive experimental/non-therapeutic dose(s) of inactive marijuana, under double-blind conditions
Inactive Alcohol Dose	placebo alcohol	Participants will receive experimental/non-therapeutic dose(s) of inactive alcohol, under double-blind conditions
Active Alcohol Dose	Alcohol	Participants will receive experimental/non-therapeutic dose(s) of active alcohol, under double-blind conditions
Active Marijuana Dose	Marijuana	Participants will receive experimental/non-therapeutic dose(s) of active marijuana, under double-blind conditions

Primary Outcome Measures

Name	Time	Method
Mean Peak for Standard Deviation in Lane Position (SDLP)	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.	Standard deviation of lane position (SDLP) of the car is the amount of weaving/swerving of the car in and out of the lane. It is a frequent metric for assessing driving ability.

Secondary Outcome Measures

Name	Time	Method
Subject-Rated Outcome: Mean Peak Score for Difficulty Concentrating	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.	Participants rated their subjective response on a Likert type scale (Not at all=0, A Little Bit=1, Moderately=2, Quite A Bit=3, Extremely=4). Greater values indicate greater drug effect. Raw data transformed to peak scores.
Observer-Rated Outcome: Mean Peak Score for Relaxed	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.	Research observer rated on a Likert type scale (Not at all=0, A Little Bit=1, Moderately=2, Quite A Bit=3, Extremely=4). Greater values indicate greater drug effect. Raw data transformed to peak scores.
Subject-Rated Outcomes: Mean Peak Score for Driving Difficulty	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.	Participants rated their subjective response on a standardized VAS scale (0 to 100). Higher scores indicate worse outcome/greater impairment. Raw data transformed to peak scores.
Subject-Rated Outcome: Mean Peak Score for Drug and Alcohol Effect	This outcome (VAS scores) was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 9 hrs)	Participants rated their subjective response on a standardized VAS scale (0 to 100). Higher scores indicate greater drug effects. Raw data transformed to peak scores.
Observer-Rated Outcome: Mean Peak Score for Good Mood	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.	Research observer rated on a Likert type scale (Not at all=0, A Little Bit=1, Moderately=2, Quite A Bit=3, Extremely=4). Greater values indicate greater drug effect. Raw data transformed to peak scores.

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States