Detection of Cannabis Impairment With ISBRG's SpotLight-THC
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in Acute Subjective Response to Cannabis Score
研究概览
简要总结
Subjects will participate in a 2-visit study protocol in which they will be administered cannabis of pre-determined concentrations and asked to complete a simulated drive in a driving simulator. Subjects will be scanned on two SpotLight-THC (Alpha and Beta iterations) devices and peripheral venous whole blood will be collected from subjects for analysis on up to four occasions on each visit.
The purpose of the investigation will be to determine whether the SpotLight-THC device is a reliable measure of THC impairment at the roadside, with an objective to identify a unique blood analyte architecture for THC impairment using near infrared light and machine learning.
详细描述
At the University of Iowa, subjects who currently use cannabis recreationally will be recruited. They will then undergo a screening visit in which consent is obtained, questionnaires are given, a physical exam is conducted and subjects will use the driving simulator to assess propensity to sickness and to familiarize them with the simulation. They will then be scheduled for their next visit. At the second visit, subjects will be administered 5-10% THC. A series of baseline tests, including a test requiring a blood sample will be administered upon arrival. After drug administration, subjects will be asked to complete a set of verbal recall questions followed by three simulated driving trials, completing 7 non-invasive SpotLight-19 scans (20 seconds x 2) and 3 blood samples throughout the visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged at least 18 years old
- •Must self-report use of cannabis at least once a month
- •Has held a valid driver's license at least 12 months
- •Must be willing to abstain from using cannabis and alcohol for 24 hours prior to each session
- •Must be willing to abstain from all other drugs not medically required for duration of the study (beginning 24 hours prior to the screening visit)
- •Must be able to drive without special or non-standard equipment
- •Must be able to meet study time commitment
- •Provides written and informed consent
排除标准
- •Diagnosis of severe medical or psychiatric condition (as judged by study physician)
- •Evidence of substance use disorder as reflected by total scores on DUDIT and AUDIT
- •Regular user of medication that may affect cognitive functioning and/or driver performance (e.g., antidepressants, benzodiazepines, stimulants, opioids) as judged by study physician
- •Family history of schizophrenia or other psychotic disorder (or taking medications for such)
- •Pregnant or test positive for pregnancy, looking to become pregnant, or breastfeeding
- •Respiratory or pulmonary disorder that would negatively affect ability to inhale and hold the cannabis dose
- •Recent (past 6 months) head injury or stroke, or current symptoms from prior head injury or stroke
- •History of heart disease, angina, heart attack, heart surgery, or myocardial infarction (or taking medications for such)
- •Untreated/Untreatable vision or auditory issues (because testing currently requires both senses)
- •History of suicidal behaviors in past two years
- •Excessive tobacco use (more than 10 cigarettes a day or 3 or more cigars or pipes per day)
- •Excessive caffeine use (6 or more servings per day)
- •Excessive alcohol (14 or more drinks per week)
- •Regular use of pain medications other than OTC
- •Use of prescription drugs not prescribed to them or illicit drugs other than cannabis
- •History of substance abuse or substance addiction
- •Expressed interest in or participation in drug abuse treatment in past 60 days
- •Currently diagnosed cannabis use disorder
- •History of negative reaction to cannabis
- •Extreme scarring on fingertips that prevents use of the device
- •Participation in night shift work
研究组 & 干预措施
Baseline followed by 5-10% THC Validation
干预措施: Cannabis(THC) inhaled (Drug)
Baseline followed by 5-10% THC Verification
干预措施: Cannabis(THC) inhaled (Drug)
结局指标
主要结局
Change in Acute Subjective Response to Cannabis Score
时间窗: At baseline, 20, 30, 60, 90, 120 and 180 minutes
The total score of the true responses (true/false scale, minimum score is 0 with a maximum score of 12). A higher score indicates greater drug effect. Used to determine subjective level of drug effect.
次要结局
- Blood Delta-9-THC(At baseline, 20, 90, and 180 minutes)
- Standard Deviation of Lateral Position (SDLP) - Distracted(Over a 20 minute drive conducted at 30, 90 and 180 minutes post dose)
- Standard Deviation of Lateral Position (SDLP) - Undistracted(Over a 20 minute drive conducted at 30, 90 and 180 minutes post dose)