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

Sponsor
Yale University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02404688
Collaborator
(none)
40
Enrollment
1
Location
4
Arms
84
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Active delta-9-THC
  • Drug: Placebo
  • Drug: Active Ethanol
  • Drug: Placebo
 Phase 1

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 Design

Study Type:
Interventional
Anticipated 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
Study Start Date :
Dec 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Road Tracking Error [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

  1. Biphasic Alcohol Effects Scale (BAES) [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.

  2. Visual Analog Scale (VAS) [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.

  3. Cognitive Test Battery [+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.

  4. Willingness to Drive Scale [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.

  5. Number of Joints Scale [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.

  6. Number of Drinks Scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Biological Studies Unit, VA Connecticut Healthcare System West Haven Connecticut United States 06516

Sponsors and Collaborators

  • Yale University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Deepak C. D'Souza, Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier:
NCT02404688
Other Study ID Numbers:
  • 1501015208
First Posted:
Mar 31, 2015
Last Update Posted:
Feb 25, 2022
Last Verified:
Feb 1, 2022
Additional relevant MeSH terms:
Marijuana Abuse
Ethanol
Dronabinol

Study Results

No Results Posted as of Feb 25, 2022