Cannabis Consumption and Driving Impairment Assessment on a Closed Course

19C066000

In a true experiment, roughly 300 volunteer participants will smoke active cannabis, a corresponding placebo, or no substance at all (control). Next, participants will complete a drive test and then be observed by actual California Highway Patrol (CHP) officers who will attempt to classify participants as impaired or unimpaired. CHP Officers will evaluate participants in the context of driving (i.e., while following participants in an actual patrol car), as part of a roadside behavioral assessment (i.e., the Advanced Roadside Impaired Driving Enforcement, or ARIDE, battery, which includes Standardized Field Sobriety Tests, or SFSTs), and as part of a Drug Recognition Expert (DRE) evaluation conducted indoors.

2023-10-03

2024-12-31

2024-12-31

Recruiting

Early phase I

300

Inclusion Criteria: * Possessing a valid California driver's license * Cannabis use in the past six months * Willing and able to abstain from alcohol, cannabis, and other recreational drugs for 24 hours prior to scheduled participation * Willing and able to avoid driving and operating heavy machinery for at least four hours after participation * Residence within approximately 15 miles of the study site * Possessing the capacity to provide informed consent Exclusion Criteria: * Completion of a roadside sobriety test during the previous 12 months * Physical or psychological conditions that can be exacerbated by cannabis use, or for which cannabis use is contraindicated * Potential presence of Cannabis Use Disorder as assessed by a modified version of the Cannabis Use Disorder Identification Test * Potential presence of Substance Use Disorder as assessed by a modified version of the Drug Abuse Screening Test * Pregnancy or breastfeeding reported * Unwillingness to be transported by taxi * Having been convicted of Driving Under the Influence (DUI) within five years prior to scheduled participation * Parole or probation status * One or more felony convictions on record involving aggressive or dangerous criminal activity * Any of the following at the time of the experimental session: breath alcohol content of .01% or greater; positive pregnancy test; cannabis consumption considered unsafe following medical checkup by the study nurse; or driving test behavior considered hazardous by the driving examiner

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a true experiment in a naturalistic setting designed to maximize ecological validity, that is, designed so that the findings can be expected to generalize to their real-world application of detecting impaired driving. The study features a randomized between-subjects design, in which the main independent variable (Substance) has three levels: active cannabis vs. placebo vs. control (i.e., no substance).', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Participants are blind to condition assignment, meaning they are not told in advance which version of the procedure they will experience. While those assigned to the true control condition will obviously realize this during the session, remaining participants are not informed whether the cigarette they smoke contains active cannabis or placebo.\n\nSimilarly, the experimenters will necessarily become aware of which individuals are in the control conditions, however, they do not know which of the remaining participants are assigned to active cannabis versus placebo conditions (i.e., the active vs. placebo cannabis cigarettes are not labeled as such).\n\nMost importantly, outcome assessors such as the officers and driving evaluators who supply the ratings that comprise the focal dependent variables will be completely blind to experimental condition, so that there is no straightforward means by which experimenter bias could affect data collected for those variables.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}

2023-09-29