Marijuana Effects on Simulated Driving Performance

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Drinking; Cannabis; Cannabis Use; Marijuana; Marijuana Usage
• Intervention / Treatment: Drug: Marijuana; Drug: Inactive marijuana; Drug: Alcohol; Drug: placebo alcohol

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40508
      • University Of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Marijuana Dose; Participants will receive experimental/non-therapeutic dose(s) of active marijuana, under double-blind conditions	Drug: Marijuana; Experimental, non-therapeutic administration of active marijuana dose(s); Other Names: Active cannabis
Placebo Comparator: Inactive Marijuana Dose; Participants will receive experimental/non-therapeutic dose(s) of inactive marijuana, under double-blind conditions	Drug: Inactive marijuana; Experimental, non-therapeutic administration of inactive marijuana dose(s); Other Names: inactive cannabis
Active Comparator: Active Alcohol Dose; Participants will receive experimental/non-therapeutic dose(s) of active alcohol, under double-blind conditions	Drug: Alcohol; Experimental, non-therapeutic administration of active alcohol dose(s); Other Names: Active alcohol
Placebo Comparator: Inactive Alcohol Dose; Participants will receive experimental/non-therapeutic dose(s) of inactive alcohol, under double-blind conditions	Drug: placebo alcohol; Experimental, non-therapeutic administration of inactive alcohol dose(s)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Peak for Standard Deviation in Lane Position (SDLP)	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject-Rated Outcomes: Mean Peak Score for Driving Difficulty	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.	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.
Subject-Rated Outcome: Mean Peak Score for Drug and Alcohol Effect	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.	This outcome (VAS scores) was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 9 hrs)
Subject-Rated Outcome: Mean Peak Score for Difficulty Concentrating	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.	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.
Observer-Rated Outcome: Mean Peak Score for Relaxed	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.	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.
Observer-Rated Outcome: Mean Peak Score for Good Mood	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.	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.

Collaborators and Investigators

• Sponsor: Shanna Babalonis, PhD
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: October 5, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: simulated driving, outpatient
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Substance-Related Disorders; Alcohol Drinking; Marijuana Abuse; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol
• Other Study ID Numbers: 43636; R21DA045101-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plans to share individual participant data with other outside researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No