Overview

This trial is active, not recruiting.

Conditions cannabis, alcohol effect, driving under the influence of alcohol and other drugs
Treatments active inhaled delta-9-thc, placebo, active oral ethanol
Phase phase 1
Sponsor Yale University
Start date March 2016
End date December 2020
Trial size 40 participants
Trial identifier NCT02709954, 1501015208.A

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Experimental)
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.
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 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.
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
Control: No active THC. Administered over 20 minutes via a vaporizer. approximately 10 minutes.
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
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.
placebo
Control: No active THC. Administered over 20 minutes via a vaporizer. approximately 10 minutes.

Primary Outcomes

Measure
Road Tracking Error
time frame: baseline, +20, +50, +120, +180 mins after start of alcohol administration

Secondary Outcomes

Measure
Biphasic Alcohol Effects Scale (BAES)
time frame: baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration
Visual Analog Scale (VAS)
time frame: baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration
Willingness to Drive Scale
time frame: baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration
Cognitive Test Battery
time frame: +40 mins after start of alcohol administration
Number of Joints Scale
time frame: baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration
Number of Drinks Scale
time frame: baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration

Eligibility Criteria

Male or female participants from 21 years up to 55 years old.

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.

Additional Information

Official title Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Sub-Study I
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Yale University.