With the increasing prevalence and use of cannabis products by the public, there exists a need to better understand the safety impact of cannabis use, particularly when it comes to subjective perceptions of drug effect and driving impairment. This study aims to evaluate the dose-dependent effects of oral Δ9-THC alone and in combination with alcohol (0.08% BAC \[Blood Alcohol Concentration\]) on driving performance and subjective feeling in healthy adults. The results of this study will address current knowledge gaps on the effects of oral Δ9-THC on driving impairment across a clinically relevant dose range.
Subject signs an IRB approved written informed consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act authorization) before any study related procedures are performed.
Subject is a healthy, non-smoking man or woman, 21 to 55 years of age, inclusive, who weighs at least 50 kg (110 lbs) and has a body mass index of 18.5 to 33.0 kg/m2, inclusive, at Screening and check-in (Day -1).
Subject possesses a valid U.S. driver's license and has driven a minimum of 600 miles per year for the previous 3 years.
During screening subjects will be assessed using a driving simulation test. Subject must not demonstrate any motion sickness as determined by the investigator and defined in the driving simulation operations manual and subject must not have erratic driving as defined in the Screening Visit Driving Practice Assessment Operational Manual.
A history of cannabis use disorder or use of any psychoactive drug in the last month.
Any reported history of alcohol intolerance.
Alcohol intolerance as detected by ethanol patch testing.
Subject has a dry mouth or history of salivary gland disfunction or surgery.
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Treatment groupsSee each treatment group below.
Food and Drug Administration (FDA)
Lead sponsor
Spaulding Clinical Research LLC
Collaborator