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Marijuana Effects on Simulated Driving Performance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03699540
Recruitment Status : Completed
First Posted : October 9, 2018
Last Update Posted : January 26, 2023
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Shanna Babalonis, PhD, University of Kentucky

Study Description
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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 the effects of alcohol. Secondary outcomes will include physiological effects, subjective- and observer-rated outcomes, and psychomotor performance under the various dose conditions.

Condition or disease Intervention/treatment Phase
Cannabis Cannabis Use Marijuana Marijuana Usage Alcohol Drinking Drug: Marijuana Drug: Alcohol Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Within-subject, randomized, placebo-controlled, double-dummy, double-blind study
Masking: Double (Participant, Investigator)
Masking Description: Double-blind, double-dummy, placebo-controlled design
Primary Purpose: Basic Science
Official Title: Marijuana Effects on Simulated Driving Performance
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : December 1, 2022
Actual Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
Drug Information available for: Ethanol

Arms and Interventions
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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 and inactive marijuana dose(s)
Other Name: Cannabis, Placebo
Placebo Comparator: Inactive Marijuana Dose
Participants will receive experimental/non-therapeutic dose(s) of inactive marijuana, under double-blind conditions
 Drug: Marijuana
Experimental, non-therapeutic administration of active and inactive marijuana dose(s)
Other Name: Cannabis, Placebo
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 and inactive alcohol dose(s)
Other Name: Alcohol, Placebo
Placebo Comparator: Inactive Alcohol Dose
Participants will receive experimental/non-therapeutic dose(s) of inactive alcohol, under double-blind conditions
 Drug: Alcohol
Experimental, non-therapeutic administration of active and inactive alcohol dose(s)
Other Name: Alcohol, Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Simulated Driving Performance [ Time Frame: These outcomes will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 9 hrs) ]
    We will examine various features of driving acuity (e.g.,break latency, lane departures)


Secondary Outcome Measures :
  1. Subject- and Observer-Rated Outcomes [ Time Frame: These outcomes (VAS scores) will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 9 hrs) ]
    Participants will report the subjective effects of the drug dose(s) on standardized measures; trained observers rate participant outcomes on standardized scales


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699540


Locations
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United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40508
Sponsors and Collaborators
Shanna Babalonis, PhD
National Institute on Drug Abuse (NIDA)
  Study Documents (Full-Text)

Documents provided by Shanna Babalonis, PhD, University of Kentucky:
Informed Consent Form  [PDF] April 25, 2022

More Information
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Responsible Party: Shanna Babalonis, PhD, Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT03699540    
Other Study ID Numbers: 43636
R21DA045101-02 ( U.S. NIH Grant/Contract )
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are no plans to share individual participant data with other outside researchers.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanna Babalonis, PhD, University of Kentucky:
simulated driving, outpatient
Additional relevant MeSH terms:
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Marijuana Abuse
Alcohol Drinking
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Drinking Behavior
 Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs