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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02404688
Other study ID # 1501015208
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date December 2015
Est. completion date December 2024

Study information

Verified date October 2023
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

To study the effects of ethanol clamped at BAC 0.04% and THC (1.05 mg in a 70 kg individual) on driving.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 55 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


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.
Placebo
Control: small amount of alcohol (quarter teaspoon), with no THC. Administered over 20 minutes.
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
Control: no alcohol, administered for a total of 80 minutes.

Locations

Country Name City State
United States Biological Studies Unit, VA Connecticut Healthcare System West Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Road Tracking Error changes in road tracking errors between timepoints to assess the effects of alcohol and THC on road tracking errors. baseline, +20, +50, +120, +180 mins after start of alcohol and THC infusion
Secondary Biphasic Alcohol Effects Scale (BAES) A scale designed to assess the stimulant and sedative effects associated with alcohol intoxication. baseline, +20, +50, +120, +180, +240 mins after start of alcohol and THC infusion
Secondary Visual Analog Scale (VAS) Feeling states associated with alcohol and cannabis intoxication will be measured using this self-report scale of feeling states. baseline, +20, +50, +120, +180 mins after start of alcohol and THC infusion
Secondary Cognitive Test Battery 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. +40 mins after start of alcohol and THC infusion
Secondary Willingness to Drive Scale 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. baseline, +20, +50, +120, +180 mins after start of alcohol and THC infusion
Secondary Number of Joints Scale Subjects will be asked to rate the number of standard joints that they believe they have been administered. baseline, +20, +50, +120, +180 mins after start of alcohol and THC infusion
Secondary Number of Drinks Scale Subjects will be asked to rate the number of standard drinks that they believe they have been administered. baseline, +20, +50, +120, +180 mins after start of alcohol and THC infusion
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