NCT06595576已完成不适用
Dose-dependent Effects of Cannabis Edibles on Simulated Driving Performance
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Standard Deviation of Lateral Position (SDLP)
研究概览
简要总结
The goal of this human laboratory experiment is to determine the acute and residual effects of a range of doses of orally administered cannabis edibles on driving simulator performance in people who use cannabis recreationally. Four conditions will be tested: placebo, low dose, medium dose and high dose. Driving performance will be tested objectively using a driving simulator during a number of pre-programmed driving scenarios. The investigators will test the hypothesis that driving performance on a high-fidelity driving simulator will decrease with increasing doses of cannabis. Secondary objectives will:
- Determine the acute and residual (24 hour) cognitive, behavioural, and physiological effects of a range of doses of orally administered cannabis edibles on subjective effects, cognitive tests, verbal memory, and mood.
- Examine how the concentration of THC in blood and oral fluids correlates with driving simulator performance, as well as cognitive, behavioural, and physiological measures. Cannabinoid levels in blood, urine and oral fluids will be measured at baseline and over a 5 hour period following drug exposure. The investigators will examine the relationship between cannabinoid levels and performance measures in this time frame.
- Explore potential biomarkers of acute exposure to cannabis edibles by analyzing the following: circulating cell-free mtDNA (ccf-mtDNA), endocannabinoids, and metabolic biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provides written and informed consent
- •Stated the willingness to comply with all study procedures
- •Recreational use of oral, vaped, smoked or edible cannabis (at least one day/week) and cannabis edibles (at least one day/month) confirmed by self-report and urine screening (i.e., positive THC result in point-of-care screening or Clinical Laboratory assay)
- •Males and females aged 19 to 45 years
- •Has held a class G license (or equivalent from another jurisdiction) for at least 12 months
- •Willing to abstain from using cannabis for 72 hours prior to each practice or test session
- •Willing to abstain from alcohol for 48 hours prior to each practice or test session, and to abstain from all other drugs not medically required for the duration of the study (beginning 48 hours prior to the practice session)
- •Lives within a radius that costs less than about $60 per taxi ride
- •Able to consume the quantity of candies and drive the driving simulator as determined by a practice session
- •A negative urine pregnancy test for those with childbearing potential
- •Use of appropriate contraception for those with childbearing potential
排除标准
- •Diagnosis of severe medical or psychiatric condition (e.g., diagnosis of a severe mood or anxiety disorder, based on self-report
- •Meets criteria for current or lifetime alcohol or other substance use disorder (DSM-5), except tobacco use disorder and caffeine use disorder
- •Regular user of medication that may affect cognitive functioning and/or driver performance (e.g. ADHD medication, benzodiazepines, stimulants, opioids)
- •Regular user of illicit substances
- •Personal or family history of schizophrenia or other psychotic disorder
- •Pregnant, looking to become pregnant, or breastfeeding
- •Concomitant therapy with sedative-hypnotics or other psychoactive drugs
- •Severe laboratory abnormalities that could create safety issues based on the judgement of the Principal Investigator
- •Cardiovascular or cerebrovascular disease
- •Severe renal or liver disease
- •Participation in another clinical or non-therapeutic study in the past month
研究组 & 干预措施
Placebo Cannabis Edibles (0 mg THC)
Experimental
Participants consume a placebo dose of cannabis edibles (0 mg THC).
干预措施: Cannabis - Placebo Dose (0 mg) (Drug)
Low Dose Cannabis Edibles (2 mg THC)
Experimental
Participants consume a low dose of cannabis edibles (2 mg THC).
干预措施: Cannabis - Low Dose (2 mg) (Drug)
Medium Dose Cannabis Edibles (10 mg)
Experimental
Participants consume a medium dose of cannabis edibles (10 mg THC).
干预措施: Cannabis - Medium Dose (10 mg) (Drug)
High Dose Cannabis Edibles (20 mg)
Experimental
Participants consume a high dose of cannabis edibles (20 mg THC).
干预措施: Cannabis - High Dose (20 mg) (Drug)
结局指标
主要结局
Standard Deviation of Lateral Position (SDLP)
时间窗: Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.
The driving simulator will objectively record SDLP during a number of pre-programmed driving scenarios.
次要结局
- Mean Speed (MS)(Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.)
- Reaction Time (RT)(Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.)
- Standard Deviation of Speed (SDS)(Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.)
- Blood concentrations of Δ9-tetrahydrocannabinol (THC), 11-hydroxy-Δ9-tetrahydrocannabinol (OH-THC), and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol (THC-COOH)(Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.)
- Oral fluid concentrations of Δ9-tetrahydrocannabinol (THC), 11-hydroxy-Δ9-tetrahydrocannabinol (OH-THC), and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol (THC-COOH) and point-of-care detection of cannabinoids(Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.)
- Heart Rate(Before cannabis exposure; 0, 30, 60, 90 minutes and 2, 3, 4 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated approximately 24 hours after dosing.)
- Blood Pressure(Before cannabis exposure; 0, 30, 60, 90 minutes and 2, 3, 4 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated approximately 24 hours after dosing.)
- Temperature(Before cannabis exposure; 0, 30, 60, 90 minutes and 2, 3, 4 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated approximately 24 hours after dosing.)
- Visual Analog Scale (VAS)(Before cannabis exposure; 0, 30, 60, 90 minutes and 2, 3, 4 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated approximately 24 hours after dosing.)
- Addiction Research Centre Inventory (ARCI)(Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.)
- Profile of Mood States (POMS)(Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.)
- Verbal Free Recall Task(Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.)
- Blood Concentrations of mtDNA(Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.)
- Blood Concentrations Endocannabinoids(Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing.)
研究者
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