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Marijuana Effects on Simulated Driving Performance

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ClinicalTrials.gov Identifier: NCT03699540
Recruitment Status : Recruiting
First Posted : October 8, 2018
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Shanna Babalonis, PhD, University of Kentucky

Tracking Information
First Submitted Date  ICMJE October 2, 2018
First Posted Date  ICMJE October 8, 2018
Last Update Posted Date July 18, 2019
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03699540 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2018)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Marijuana Effects on Simulated Driving Performance
Official Title  ICMJE Marijuana Effects on Simulated Driving Performance
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • Cannabis
  • Cannabis Use
  • Marijuana
  • Marijuana Usage
  • Alcohol Drinking
Intervention  ICMJE
  • Drug: Marijuana
    Experimental, non-therapeutic administration of active and inactive marijuana dose(s)
    Other Name: Cannabis, Placebo
  • Drug: Alcohol
    Experimental, non-therapeutic administration of active and inactive alcohol dose(s)
    Other Name: Alcohol, Placebo
Study Arms  ICMJE
  • Experimental: Active Marijuana Dose
    Participants will receive experimental/non-therapeutic dose(s) of active marijuana, under double-blind conditions
    Intervention: Drug: Marijuana
  • Placebo Comparator: Inactive Marijuana Dose
    Participants will receive experimental/non-therapeutic dose(s) of inactive marijuana, under double-blind conditions
    Intervention: Drug: Marijuana
  • Active Comparator: Active Alcohol Dose
    Participants will receive experimental/non-therapeutic dose(s) of active alcohol, under double-blind conditions
    Intervention: Drug: Alcohol
  • Placebo Comparator: Inactive Alcohol Dose
    Participants will receive experimental/non-therapeutic dose(s) of inactive alcohol, under double-blind conditions
    Intervention: Drug: Alcohol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 5, 2018)
105
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Shanna Babalonis, Ph.D. (859) 257-1881 babalonis@uky.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03699540
Other Study ID Numbers  ICMJE 43636
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There are no plans to share individual participant data with other outside researchers.
Responsible Party Shanna Babalonis, PhD, University of Kentucky
Study Sponsor  ICMJE Shanna Babalonis, PhD
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Kentucky
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP