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

This study is currently recruiting participants.
Verified June 2017 by Deepak C. D'Souza, Yale University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02404688
First Posted: March 31, 2015
Last Update Posted: June 23, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University
  Purpose
The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.

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

Study Type: Interventional
Study Design: 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

Further study details as provided by Deepak C. D'Souza, Yale University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: February 2015
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active THC and Placebo Ethanol 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: no alcohol, administered for a total of 80 minutes.
Experimental: Active THC and Active Ethanol 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: 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.
Experimental: Placebo THC and Active Ethanol 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.
Placebo Comparator: Placebo THC and Placebo Ethanol Drug: Placebo
Control: small amount of alcohol (quarter teaspoon), with no THC. Administered over 20 minutes.
Drug: Placebo
Control: no alcohol, administered for a total of 80 minutes.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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).
  • 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.
  Contacts and Locations
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): NCT02404688


Contacts
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

Locations
United States, Connecticut
Biological Studies Unit, VA Connecticut Healthcare System Recruiting
West Haven, Connecticut, United States, 06516
Contact: Christina Luddy, BS    203-932-5711 ext 4549    christina.luddy@yale.edu   
Principal Investigator: Deepak C. D'Souza, M.D.         
Sponsors and Collaborators
Yale University
  More Information

Responsible Party: Deepak C. D'Souza, Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT02404688     History of Changes
Other Study ID Numbers: 1501015208
First Submitted: March 26, 2015
First Posted: March 31, 2015
Last Update Posted: June 23, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Ethanol
Dronabinol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Hallucinogens
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists