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临床试验/NCT04325958
NCT04325958
招募中
不适用

The Influence of Age on Driving-related Cannabis Effects: Exploring Cannabis Use Frequency and Related Factors

Centre for Addiction and Mental Health1 个研究点 分布在 1 个国家目标入组 128 人2024年3月27日
适应症Cannabis
干预措施CannabisPlacebos
相关药物CannabisPlacebos

概览

阶段
不适用
干预措施
Cannabis
疾病 / 适应症
Cannabis
发起方
Centre for Addiction and Mental Health
入组人数
128
试验地点
1
主要终点
Standard deviation of lateral position
状态
招募中
最后更新
上个月

概览

简要总结

Epidemiological studies suggest that the use of cannabis is associated with an increase in the risk of motor vehicle collisions. It is also known that younger users may be at increased risk for motor vehicle collisions. Further, the frequency with which cannabis is used may be an important variable in determining the effects of cannabis on driving. The purpose of the present study will be to investigate the effects of cannabis on simulated driving in young as compared to middle-aged drivers. Half of the participants will be occasional users of cannabis and half will be frequent users of cannabis.

详细描述

Epidemiological studies have established that the use of cannabis can increase the risk of a motor vehicle collision. A number of variables can influence the effects of cannabis on driving. For example, frequent users of cannabis have been shown to have different cognitive and physiological responses to cannabis as compared to occasional users. In addition, we know that younger drivers are more likely to be involved in motor vehicle collisions after alcohol use as compared to older users. The contribution of age and experience with cannabis on cannabis-mediated effects on driving have yet to be delineated in laboratory studies. The purpose of the present investigation will be to determine whether cannabis has different effects on driving in young, as compared to middle aged, drivers. Half of each age group will be occasional users of cannabis and the other half will be frequent users. Eligible participants will attend the laboratory for two test sessions; in one session they will smoke a cannabis cigarette and in the other they smoke a placebo cigarette. Participants will drive a driving simulator before and after smoking the cigarette. Blood for measurement of THC and metabolites will also be collected before smoking the cigarette and at a number of times after smoking. Subjective and cognitive tasks will be completed before and after smoking. It is hoped that the findings of this study will help to inform public perception and policy into the potential effects of cannabis on driving.

注册库
clinicaltrials.gov
开始日期
2024年3月27日
结束日期
2027年3月1日
最后更新
上个月
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

入排标准

入选标准

  • 19-25 or 35-45 years of age;
  • Use of smoked cannabis at least once in the past 6 months.
  • Use of smoked or vaped cannabis primarily for recreational purposes on up to 1 day per week or on at least 6 days per week in the past 3 months;
  • Holds a class G or G2 Ontario driver's licence (or equivalent from another jurisdiction) for at least 12 months;
  • Willing to abstain from using alcohol for 24 hours and cannabis for 72 hours prior to Practice and Test Sessions;
  • Willing to abstain from all other drugs not prescribed for medical purposes for 48 hours prior to Practice and Test Sessions;
  • Resides within Toronto (study site) or can reside with friends/family in Toronto after a Test Session; this area may be extended to the Greater Toronto area if recruitment challenges arise;
  • Participant willing to use appropriate contraception until their participation in the study is completed;
  • Provides written and informed consent.

排除标准

  • Use of cannabis primarily for therapeutic purposes, or equally for therapeutic and recreational purposes;
  • Diagnosis of medical condition that contraindicates use of cannabis determined by self-report as judged by the Principal Investigator and a study physician; this includes a history of hypersensitivity to cannabinoids smoke, respiratory disease and/or severe cardiovascular, cerebrovascular, renal or liver disease, and bleeding disorders. Smoking cannabis is not recommended for individuals with respiratory diseases, and they will be excluded;
  • Diagnosis of psychiatric condition that contraindicates use of cannabis determined by self-report or SCID-5;
  • Participants of childbearing potential: Pregnancy (point-of-care test) or breastfeeding;
  • Meets criteria for current or lifetime alcohol or other substance use disorder (DSM-5), except tobacco use disorder and caffeine use disorder;
  • Is a regular user of medications that affect brain function (based on self-report); this includes concomitant therapy with sedative-hypnotics or other psychoactive drugs
  • Use of anti-hypertensives;
  • First-degree relative diagnosed with schizophrenia or another psychotic disorder.
  • Participation in a past driving study at CAMH (to limit practice effects).
  • Participation in a clinical study concurrent with their participation in this study.

研究组 & 干预措施

Age group 19 to 25

Participants will complete two sessions: one where they drive the simulator before and after smoking a placebo cannabis cigarette (\<1% THC), the other where they drive the simulator before and after smoking an active cannabis cigarette (15% ± 5% THC).

干预措施: Cannabis

Age group 19 to 25

Participants will complete two sessions: one where they drive the simulator before and after smoking a placebo cannabis cigarette (\<1% THC), the other where they drive the simulator before and after smoking an active cannabis cigarette (15% ± 5% THC).

干预措施: Placebos

Age group 35 to 45

Participants will complete two sessions: one where they drive the simulator before and after smoking a placebo cannabis cigarette (\<1% THC), the other where they drive the simulator before and after smoking an active cannabis cigarette (15% ± 5% THC).

干预措施: Cannabis

Age group 35 to 45

Participants will complete two sessions: one where they drive the simulator before and after smoking a placebo cannabis cigarette (\<1% THC), the other where they drive the simulator before and after smoking an active cannabis cigarette (15% ± 5% THC).

干预措施: Placebos

结局指标

主要结局

Standard deviation of lateral position

时间窗: Before cannabis exposure and 30 minutes and 2 hours after cannabis exposure

A measure of 'weaving' when driving the simulator (meters)

次要结局

  • Maximum speed(Before cannabis exposure and 25 minutes and 2 hours after cannabis exposure)
  • Braking latency(Before cannabis exposure and 25 minutes and 2 hours after cannabis exposure)
  • Number of collisions(Before cannabis exposure and 25 minutes and 2 hours after cannabis exposure)
  • Trail Making Test(Before cannabis exposure and 70 minutes after cannabis)
  • Vienna Risk-Taking Test(One hour after cannabis exposure)
  • Systolic blood pressure(Before cannabis exposure and 5, 15, 25 minutes and 1, 2, 3, 4 and 5 hours after cannabis)
  • Following distance(Before cannabis exposure and 25 minutes and 2 hours after cannabis exposure)
  • Diastolic blood pressure(Before cannabis exposure and 5, 15, 25 minutes and 1, 2, 3, 4 and 5 hours after cannabis)
  • Mean speed(Before cannabis exposure and 25 minutes and 2 hours after cannabis exposure)
  • Standard deviation of speed(Before cannabis exposure and 25 minutes and 2 hours after cannabis exposure)
  • Heart rate(Before cannabis exposure and 5, 15, 25 minutes and 1, 2, 3, 4 and 5 hours after cannabis)
  • Visual Analog Scales such as 'I feel this effect', 'I like this drug effect', 'I feel the good effects'(Before cannabis exposure and 5, 15, 25 minutes and 1, 2, 3, 4 and 5 hours after cannabis)
  • Blood concentration of delta-9-tetrahydrocannabinol (THC)(Before cannabis exposure and 25 minutes and 2 hours after cannabis)
  • Blood concentration of carboxy-tetrahydrocannabinol (THC-COOH)(Before cannabis exposure and 25 minutes and 2 hours after cannabis)
  • Blood concentration of 11-hydroxy-tetrahydrocannabinol (11-OH-THC)(Before cannabis exposure and 25 minutes and 2 hours after cannabis)
  • Verbal Free Recall Task(Before cannabis exposure and 70 minutes after cannabis)
  • Grooved Pegboard Test(Before cannabis exposure and 70 minutes after cannabis)
  • Simple and Choice Reaction Time Tasks(Before cannabis exposure and 70 minutes after cannabis)

研究点 (1)

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