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Marijuana Effects on Simulated Driving Performance

Sponsor
Shanna Babalonis, PhD (Other)
Overall Status
Recruiting
CT.gov ID
NCT03699540
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
105
Enrollment
1
Location
4
Arms
41
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Within-subject, randomized, placebo-controlled, double-dummy, double-blind studyWithin-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 :
Jul 1, 2019
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Alcohol, Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Simulated Driving Performance [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 [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

    Criteria

    Ages Eligible for Study:
    21 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 University of Kentucky Lexington Kentucky United States 40508

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanna Babalonis, PhD, Principal Investigator, University of Kentucky
    ClinicalTrials.gov Identifier:
    NCT03699540
    Other Study ID Numbers:
    • 43636
    • R21DA045101-02
    First Posted:
    Oct 9, 2018
    Last Update Posted:
    Dec 23, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Shanna Babalonis, PhD, Principal Investigator, University of Kentucky
    simulated driving, outpatient
    Additional relevant MeSH terms:
    Marijuana Abuse
    Alcohol Drinking
    Ethanol

    Study Results

    No Results Posted as of Dec 23, 2021