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.
Crossover
5 mg Dronabinol (Marinol®) + Placebo Beverage
DrugSubjects in this arm will receive one dose of 5 mg THC (Dronabinol) with a placebo beverage in one of the assigned treatment days.
10 mg Dronabinol (Marinol®) + Placebo Beverage
DrugSubjects in this arm will receive one dose of 10 mg THC (Dronabinol) with a placebo beverage in one of the assigned treatment days.
5 mg Dronabinol (Marinol®) + Alcohol Beverage
DrugSubjects in this arm will receive one dose of 5 mg THC (Dronabinol) with an alcoholic beverage (to achieve a target BAC of 0.08%) in one of the assigned treatment days.
10 mg Dronabinol (Marinol®) + Alcohol Beverage
DrugSubjects in this arm will receive one dose of 10 mg THC (Dronabinol) with an alcoholic beverage (to achieve a target BAC of 0.08%) in one of the assigned treatment days.
Placebo Capsule + Alcohol Beverage
DrugSubjects in this arm will receive placebo capsule with an alcoholic beverage (to achieve a target BAC of 0.08%) in one of the assigned treatment days.
Placebo Capsule + Placebo Beverage
DrugSubjects in this arm will receive a placebo capsule with a placebo beverage in one of the assigned treatment days.
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Treatment groupsSee each treatment group below.
Simulated driving performance as measured by Standard Deviation of Lateral Position (SDLP) after Δ9-THC administration alone or in combination with alcohol compared to alcohol alone.
Simulated driving performance will be measured by the endpoint standard deviation of lateral position (SDLP) using a STISIM (model M4000-R) driving simulator after Δ9-THC administration (5 mg, 10 mg, 5 mg with alcohol, 10 mg with alcohol) compared to active control (alcohol alone).
Simulated driving performance as measured by Standard Deviation of Lateral Position (SDLP) after Δ9-THC administration alone or in combination with alcohol compared to placebo.
Simulated driving performance will be measured by the endpoint standard deviation of lateral position (SDLP) using a STISIM (model M4000-R) driving simulator after Δ9-THC administration (5 mg, 10 mg, 5 mg with alcohol, 10 mg with alcohol) compared to placebo.
Simulated driving performance as measured by Standard Deviation of Speed Position (SDSP) after Δ9-THC administration alone or in combination with alcohol compared to placebo.
Simulated driving performance will be measured by the endpoint standard deviation of speed position (SDSP) using a STISIM (model M4000-R) driving simulator after Δ9-THC administration (5 mg, 10 mg, 5 mg with alcohol, 10 mg with alcohol) compared to placebo.
Simulated driving performance as measured by Standard Deviation of Speed Position (SDSP) after Δ9-THC administration alone or in combination with alcohol compared to alcohol alone.
Simulated driving performance will be measured by the endpoint standard deviation of speed position (SDSP) using a STISIM (model M4000-R) driving simulator after Δ9-THC administration (5 mg, 10 mg, 5 mg with alcohol, 10 mg with alcohol) compared to alcohol alone.
Maximum subjective self-rated driving impairment after Δ9-THC administration alone or in combination with alcohol compared to placebo.
Maximum subjective self-rated driving impairment after Δ9-THC administration (5 mg, 10 mg, 5 mg with alcohol, 10 mg with alcohol) compared to placebo will be measured by the VAS question (VAS "drug driving impairment"): "How much did the study drug affect your driving?"
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Food and Drug Administration (FDA)
Lead sponsor
Spaulding Clinical Research LLC
Collaborator
