Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition

ID: NCT02404688

Status: Recruiting

Phase: Phase 1

Start Date: February 01, 2015

First Submitted: March 26, 2015

Last Updated: June 21, 2017

Results: N/A

Organization: Yale University

Sponsors & Collaborators: Yale University

Location: United States

Conditions: Cannabis, Alcohol Effect, Driving Under the Influence of Alcohol and Other Drugs

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Study Details
No Results Posted

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.

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.

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

Tracking Information

First Submitted Date	March 26, 2015
Last Update Posted Date	June 21, 2017
Start Date	February 01, 2015
Anticipated Completion Date	December 01, 2020
Primary Completion Date	December 01, 2020
Results First Submitted Date	N/A
Received Results Disposit Date	N/A

Current 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.

Original Primary Outcome Measures

Not Available

Current 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.

Original Secondary Outcome Measures

Not Available

Study Design

Brief Title	Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition
Official Title	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	Interventional
Study Phase	Phase 1
Estimated Enrollment	40
Allocation	Randomized
Interventional Model	Crossover Assignment
Masking	Quadruple
Primary Purpose	Basic Science
Conditions	Alcohol Effect Cannabis Driving Under the Influence of Alcohol and Other Drugs
Target Follow-Up Duration	N/A
Biospecimen:	N/A
Sampling Method	N/A
Study Population	N/A
Intervention	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. Other Names Drug: Placebo Control: small amount of alcohol (quarter teaspoon), with no THC. Administered over 20 minutes. Other Names 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. Other Names Drug: Placebo Control: no alcohol, administered for a total of 80 minutes. Other Names
Study Groups/Cohorts	Active THC and Placebo Ethanol Active THC and Active Ethanol Placebo THC and Active Ethanol Placebo THC and Placebo Ethanol
Study Arms	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. Experimental Active THC and Active Ethanol 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 Active THC and Placebo Ethanol Drug : Placebo Control: no alcohol, administered for a total of 80 minutes. 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. Experimental Placebo THC and Active Ethanol 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. Placebo Comparator Placebo THC and Placebo Ethanol Drug : Placebo Control: small amount of alcohol (quarter teaspoon), with no THC. Administered over 20 minutes. Placebo Comparator Placebo THC and Placebo Ethanol Drug : Placebo Control: no alcohol, administered for a total of 80 minutes.

Arm	Intervention/Treatment
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.
Experimental Active THC and Active Ethanol	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 Active THC and Placebo Ethanol	Drug : Placebo Control: no alcohol, administered for a total of 80 minutes.
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.
Experimental Placebo THC and Active Ethanol	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.
Placebo Comparator Placebo THC and Placebo Ethanol	Drug : Placebo Control: small amount of alcohol (quarter teaspoon), with no THC. Administered over 20 minutes.
Placebo Comparator Placebo THC and Placebo Ethanol	Drug : Placebo Control: no alcohol, administered for a total of 80 minutes.

Recruitment Information

Recruitment Status:	Recruiting
Enrollment	40
Completion Date	December 01, 2020
Eligibility 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.
Gender	All
Age	21 Years to 55 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Neeraj Madivala, BA 203-932-5711 ext 4650 [email protected] Christina Luddy, BS 203-932-5711 ext 4549 [email protected]
Listed Location Countries	United States

Administrative Information

NCT Number:	NCT02404688
Other Study ID Numbers	1501015208
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement	Not Available
Responsible Party	Deepak C. D'Souza, Yale University
Study Sponsor	Yale University
Collaborators	Not Available
Investigators	Not Available