Randomised, Controlled, Interventional Single-center Study for the Design and Evaluation of an In-vehicle Real-time System for Detecting Cannabis-impaired Driving (CID)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy (AUROC) of a multimodal machine-learning model for detection of cannabis-impaired driving
研究概览
简要总结
The goal of this clinical trial is to evaluate whether in-vehicle sensor data can be used to detect cannabis-impaired driving in healthy adult recreational cannabis users.
The study aims to assess whether changes in vehicle, driver, and physiological sensor data can distinguish sober driving from cannabis-impaired driving, and how driving performance changes from baseline to approximately 1 to 6 hours after controlled cannabis consumption.
Researchers will compare driving behavior and in-vehicle sensor data from participants who receive controlled cannabis administration with data from a randomized reference group without cannabis exposure, to determine whether cannabis-related impairment driving can be identified on the basis of machine learning.
Participants will complete screening and baseline assessments and drive an instrumented vehicle on a closed test track under sober conditions. Participants assigned to the experimental arm will receive controlled cannabis administration, while participants in the reference arm will receive no intervention. All participants will perform repeated standardized driving sessions over several hours and complete traffic-medical, traffic-psychological, and in-vehicle pre-driving tests. Biological samples and in-vehicle sensor data will be collected throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent as documented by signature
- •Recreational cannabis-consumption (more than once per month)
- •In possession of a definite Swiss or European Union (EU) driving license
- •At least 21 years old
- •Active, regular driving a car in the last 6 months
- •Must be in good health condition
- •No special equipment needed when driving (special seats, levers, etc.)
- •Fluent in (Swiss) German and no speech impairment
排除标准
- •Health concerns where cannabis consumption is contra-indicated (such as: high blood pressure, psychiatric problems (e.g. psychosis, depression, attention-deficit conditions, etc.)
- •Cannabis-abstinence or excessive consumption, , assessed using the Cannabis Use Disorders Identification Test-Revised (CUDIT-R)
- •For women: pregnancy or breastfeeding or if intention to become pregnant during study period (time between telephone screening and study day (visit 2)
- •Alcohol misuse or excessive alcohol consumption habits/risky drinking behaviour, assessed using the Alcohol Use Disorders Identification Test (AUDIT) and/or phosphatidylethanol (PEth) in capillary blood > 200 ng/mL at first visit
- •If breath alcohol test is positive at Visit 1 or Visit 2 (study day)
- •Consumption of drugs of abuse (others than cannabis) within 4 weeks before the study
- •Consumption of medications / pharmaceutical drugs which interfere with driving ability
- •Inability to follow the procedures of the study, e.g., due to language
研究组 & 干预措施
Reference (No Cannabis)
Participants assigned to this reference arm receive no cannabis administration. They complete the same screening procedures, standardized driving sessions, assessments, and data collection as the experimental group under sober conditions, following the same schedule and time points. All driving sessions are conducted with a certified driving instructor seated in the front passenger seat with access to dual pedals, ensuring identical safety conditions. This arm serves as a non-impaired reference for comparison of driving behavior and in-vehicle sensor data.
Controlled Cannabis Administration
Participants assigned to this arm receive a single, controlled inhalative administration of cannabis by smoking a THC-containing joint with a target dose of approximately 0.67 mg THC per kg body weight. Participants complete standardized driving sessions in an instrumented vehicle on a closed test track under sober baseline conditions and repeatedly after cannabis administration (approximately 1-6 hours post-dose). All driving sessions are conducted with a certified driving instructor seated in the front passenger seat with access to dual pedals, allowing immediate intervention if required. Multimodal in-vehicle sensor data, physiological signals, driving performance measures, and biological samples are collected throughout the study.
干预措施: Cannabis (THC) (Drug)
结局指标
主要结局
Diagnostic accuracy (AUROC) of a multimodal machine-learning model for detection of cannabis-impaired driving
时间窗: Baseline (sober driving) and up to 6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.
Area under the receiver operating characteristic curve (AUROC) of a single machine-learning classifier that integrates multimodal in-vehicle data (including vehicle controller area network \[CAN\] data, driver monitoring camera \[DMC\] features, and physiological signals). All modalities are combined into one predictive model, and performance is reported as one aggregated AUROC value distinguishing non-impaired (sober) driving from cannabis-impaired driving.
次要结局
- Diagnostic accuracy (AUROC) using CAN data(Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.)
- Diagnostic accuracy (AUROC) using DMC data(Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.)
- Diagnostic accuracy (AUROC) of a physiology-based machine-learning model for detection of cannabis-impaired driving(Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.)
- Change in driving behavior derived from vehicle CAN data(Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.)
- Change in driver gaze behavior derived from DMC data(Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.)
- Change in head movement behavior derived from DMC data(Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.)
- Driving instructor assessment of driving performance(Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.)
- Diagnostic accuracy (AUROC) of an in-vehicle pre-driving readiness test for detection of cannabis-impaired driving(Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.)
- Performance in the standardized Psytest assessment(Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.)
- Self-reported subjective effects(Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.)
- Cannabinoid biomarker concentrations in biological samples(Baseline in all participants, and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm.)
- Incidence of adverse events(From the first study procedure (i.e. baseline assessment) to the end of the main study day (i.e. driving assessment) expected to be on average up to 6 hours.)
- Change in heart rate during driving(Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.)
- Change in oxygen saturation during driving(Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.)
- Change in electrodermal activity during driving(Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.)
- Change in skin temperature during driving(Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.)
- Change in respiration during driving(Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.)