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Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition (THC-ETOH)

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ClinicalTrials.gov Identifier: NCT02404688
Recruitment Status : Recruiting
First Posted : March 31, 2015
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University

Tracking Information
First Submitted Date  ICMJE March 26, 2015
First Posted Date  ICMJE March 31, 2015
Last Update Posted Date January 9, 2019
Study Start Date  ICMJE February 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2016)
Road Tracking Error [ Time Frame: baseline, +20, +50, +120, +180 mins after start of alcohol and THC infusion ]
changes in road tracking errors between timepoints to assess the effects of alcohol and THC on road tracking errors.
Original Primary Outcome Measures  ICMJE
 (submitted: March 30, 2015)
Road Tracking Error [ Time Frame: up to 40 minutes ]
Change History Complete list of historical versions of study NCT02404688 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2016)
  • Biphasic Alcohol Effects Scale (BAES) [ Time Frame: baseline, +20, +50, +120, +180, +240 mins after start of alcohol and THC infusion ]
    A scale designed to assess the stimulant and sedative effects associated with alcohol intoxication.
  • Visual Analog Scale (VAS) [ Time Frame: baseline, +20, +50, +120, +180 mins after start of alcohol and THC infusion ]
    Feeling states associated with alcohol and cannabis intoxication will be measured using this self-report scale of feeling states.
  • Cognitive Test Battery [ Time Frame: +40 mins after start of alcohol and THC infusion ]
    Several computer tasks will be administered to assess alcohol and THC effects on driving related cognition, including: visual vigilance, visual motor function, attention and working memory, and processing speed.
  • Willingness to Drive Scale [ Time Frame: baseline, +20, +50, +120, +180 mins after start of alcohol and THC infusion ]
    Subjects will be asked to rate their willingness to drive at their current state in the context of various scenarios including willingness to drive from testing facility to a number of destinations that are different driving distances.
  • Number of Joints Scale [ Time Frame: baseline, +20, +50, +120, +180 mins after start of alcohol and THC infusion ]
    Subjects will be asked to rate the number of standard joints that they believe they have been administered.
  • Number of Drinks Scale [ Time Frame: baseline, +20, +50, +120, +180 mins after start of alcohol and THC infusion ]
    Subjects will be asked to rate the number of standard drinks that they believe they have been administered.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2015)
  • Biphasic Alcohol Effects Scale (BAES) [ Time Frame: up to 40 minutes ]
    A scale designed to assess the stimulant and sedative effects associated with alcohol intoxication.
  • Visual Analog Scale (VAS) [ Time Frame: up to 40 minutes ]
    Feeling states associated with alcohol and cannabis intoxication will be measured using this self-report scale of feeling states.
  • Cognitive Test Battery [ Time Frame: up to 40 minutes ]
    Several computer tasks will be administered to assess alcohol and THC effects on driving related cognition, including: visual vigilance, visual motor function, attention and working memory, and processing speed.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition
Official Title  ICMJE Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition
Brief Summary The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.
Detailed Description To study the effects of ethanol clamped at BAC 0.04% and THC (1.05 mg in a 70 kg individual) on driving.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Cannabis
  • Alcohol Effect
  • Driving Under the Influence of Alcohol and Other Drugs
Intervention  ICMJE
  • Drug: Active delta-9-THC
    Low dose (0.015 mg/kg = 1.05 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4 of a marijuana cigarette, or "joint". Administered over 20 minutes.
  • Drug: Placebo
    Control: small amount of alcohol (quarter teaspoon), with no THC. Administered over 20 minutes.
  • Drug: Active Ethanol
    Target BrAC of 0.04% reached over 20 minutes and then clamped to maintain this dose for an additional 60 minutes. This dose is equivalent to consuming approximately 2 drinks over 1 hour. Administered over a total of 80 minutes.
  • Drug: Placebo
    Control: no alcohol, administered for a total of 80 minutes.
Study Arms  ICMJE
  • Experimental: Active THC and Placebo Ethanol
    Interventions:
    • Drug: Active delta-9-THC
    • Drug: Placebo
  • Experimental: Active THC and Active Ethanol
    Interventions:
    • Drug: Active delta-9-THC
    • Drug: Active Ethanol
  • Experimental: Placebo THC and Active Ethanol
    Interventions:
    • Drug: Placebo
    • Drug: Active Ethanol
  • Placebo Comparator: Placebo THC and Placebo Ethanol
    Interventions:
    • Drug: Placebo
    • Drug: Placebo
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: March 30, 2015)
40
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:

  • Males or females 21 to 55 years of age (extremes included).
  • Exposed to cannabis at least once.
  • Exposed to alcohol at least once.
  • Able to provide informed consent.

Exclusion Criteria:

  • Cannabis naive.
  • Alcohol naive.
  • Positive pregnancy screen
  • Hearing deficits.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Neeraj Madivala, BA 203-932-5711 ext 4650 neeraj.madivala@yale.edu
Contact: Christina Luddy, BS 203-932-5711 ext 4549 christina.luddy@yale.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02404688
Other Study ID Numbers  ICMJE 1501015208
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Deepak C. D'Souza, Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yale University
Verification Date January 2019

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