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Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Sub-Study I (THC-ETOH-I)

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ClinicalTrials.gov Identifier: NCT02709954
Recruitment Status : Recruiting
First Posted : March 16, 2016
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University

Brief Summary:
The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.

Condition or disease Intervention/treatment Phase
Cannabis Alcohol Effect Driving Under the Influence of Alcohol and Other Drugs Drug: Active inhaled delta-9-THC Drug: Placebo Drug: Active Oral Ethanol Phase 1

Detailed Description:
To study the effects of oral ethanol (a target BAC of ~0.04 g/dl; equivalent to consuming approximately 2 drinks over 1 hour) and vaporized THC (4 mg of THC dissolved in an ethanolic solution; equivalent to smoking approximately 1/4 of a marijuana cigarette, or "joint") on driving.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Sub-Study I
Study Start Date : March 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Active THC and Placebo Ethanol Drug: Active inhaled delta-9-THC
Low dose THC (~4 mg), dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4 of a marijuana cigarette, or "joint". Administered over 20 minutes via a vaporizer.

Drug: Placebo
Control: Approximately 4 drinks of orange juice or ginger ale covered by a trace amount of ethanol on the surface, each administered over approximately 10 minutes.

Experimental: Active THC and Active Ethanol Drug: Active inhaled delta-9-THC
Low dose THC (~4 mg), dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4 of a marijuana cigarette, or "joint". Administered over 20 minutes via a vaporizer.

Drug: Active Oral Ethanol
0.4 g/kg ethanol in orange juice or ginger ale to reach a target BrAC of approximately 0.04%. This dose is equivalent to consuming approximately 2 standard drinks over 1 hour. Approximately 4 drinks, each administered over approximately 10 minutes.

Experimental: Placebo THC and Active Ethanol Drug: Placebo
Control: No active THC. Administered over 20 minutes via a vaporizer. approximately 10 minutes.

Drug: Active Oral Ethanol
0.4 g/kg ethanol in orange juice or ginger ale to reach a target BrAC of approximately 0.04%. This dose is equivalent to consuming approximately 2 standard drinks over 1 hour. Approximately 4 drinks, each administered over approximately 10 minutes.

Placebo Comparator: Placebo THC and Placebo Ethanol Drug: Placebo
Control: Approximately 4 drinks of orange juice or ginger ale covered by a trace amount of ethanol on the surface, each administered over approximately 10 minutes.

Drug: Placebo
Control: No active THC. Administered over 20 minutes via a vaporizer. approximately 10 minutes.




Primary Outcome Measures :
  1. Road Tracking Error [ Time Frame: baseline, +20, +50, +120, +180 mins after start of alcohol administration ]

Secondary Outcome Measures :
  1. Biphasic Alcohol Effects Scale (BAES) [ Time Frame: baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration ]
    A scale designed to assess the stimulant and sedative effects associated with alcohol intoxication.

  2. Visual Analog Scale (VAS) [ Time Frame: baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration ]
    Feeling states associated with alcohol and cannabis intoxication will be measured using this self-report scale of feeling states.

  3. Willingness to Drive Scale [ Time Frame: baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration ]
    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.

  4. Cognitive Test Battery [ Time Frame: +40 mins after start of alcohol administration ]

    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.


  5. Number of Joints Scale [ Time Frame: baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration ]
    Subjects will be asked to rate the number of standard joints that they believe they have been administered.

  6. Number of Drinks Scale [ Time Frame: baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration ]
    Subjects will be asked to rate the number of standard drinks that they believe they have been administered.



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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males or females 21 to 55 years of age (extremes included).
  • Occasional current cannabis users.
  • Experience with drinking 2 or more standard drinks of alcohol at least once in lifetime.
  • Able to provide informed consent.

Exclusion Criteria:

  • Cannabis naïve.
  • Alcohol naïve.
  • Positive pregnancy screen
  • Hearing deficits.

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): NCT02709954


Contacts
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Contact: Leigh Taylor Flynn, BS 203-932-5711 ext 2557 leigh.flynn@yale.edu
Contact: Christina Luddy, BS 203-932-5711 ext 4549 christina.luddy@yale.edu

Locations
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United States, Connecticut
Biological Studies Unit, VA Connecticut Healthcare System Recruiting
West Haven, Connecticut, United States, 06516
Contact: Neeraj Madivala, BA    203-932-5711 ext 4650    Neeraj.Madivala@yale.edu   
Principal Investigator: Deepak C. D'Souza, M.D.         
Sponsors and Collaborators
Yale University

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Responsible Party: Deepak C. D'Souza, Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT02709954     History of Changes
Other Study ID Numbers: 1501015208.A
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs