NCT06255054招募中不适用
Novel Approaches to Assessing Cannabis Impaired Driving
Colorado School of Public Health1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2020年6月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Driving Impairment
研究概览
简要总结
Researchers at the University of Colorado Anschutz Medical Campus, Colorado School of Public Health, and Injury & Violence Prevention Center want to learn more about how people are affected by cannabis in different ways. We will use a driving simulator to compare the driving performance of adults who use cannabis daily, occasionally or have not recently used cannabis.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The following are inclusion criteria for participants to be enrolled in any of the four phases of the study:
- •Participants who are ≥21 years old and ≤55 years old
- •Participants who are able to provide written, informed consent
- •Participants with active healthcare coverage (including health insurance, Medicaid, etc.)
- •Participants who are willing to complete up to two in-person study visits (one for Phases 1 & 2, and two for Phases 3 & 4), including up to two urine drug screens, two alcohol breathalyzer tests, and one urine pregnancy test (if applicable)
- •Participants who agree to refrain from using non-prescription psychotropic drugs (e.g., ecstasy), hallucinogens, and synthetic cannabinoids during the study
- •Participants who agree to refrain from drinking >3 alcoholic drinks the day prior to the data collection study visit (the single visit for Phases 1 & 2, and the second visit for Phases 3 & 4)
- •Participants who agree to refrain from using any cannabis products for at least 8 hours prior to the data collection study visit (the single visit for Phases 1 & 2, and the second visit for Phases 3 & 4)
- •Participants who are willing to provide and use their own cannabis product that has been procured from a licensed dispensary, is labeled with THC potency, and contains <2% CBD (cannabis use groups only; the single visit for Phases 1 & 2, and the second visit for Phases 3 & 4)
- •Participants who agree to have a sober driver pick them up after the data collection study visit (cannabis use groups only; the single visit for Phases 1 & 2, and the second visit for Phases 3 & 4)
- •Participants who take at least 2 inhalations ("hits") during their typical inhalational (smoking/vaporizing) sessions, or ingest at least 5 mg of THC when they consume edible cannabis products (cannabis use groups only)
- •Participants who are willing to provide a sample of their cannabis to be independently tested for potency and terpene content (Phases 1, 3 & 4 only)
排除标准
- •The following are exclusion criteria for participants to be enrolled in any of the four phases of the study:
- •Participants who have nocturnal schedules (e.g., work night shifts)
- •Participants with a history of abuse or addiction to substances other than cannabis (e.g., prescription and non-prescription pharmaceuticals, alcohol, or illicit drugs)
- •Participants who have expressed an interest in substance abuse treatment within the 60 days prior to study enrollment
- •Participants who report consuming an average of >3 alcoholic drinks per day in the 30 days prior to study enrollment
- •Participants with any past or current diagnosis of schizophrenia, narcolepsy, heart disease, epilepsy, or a traumatic brain injury
- •Participants who are currently experiencing untreated bipolar disorder, major depression, sleep apnea, or other uncontrolled medical conditions as determined by the investigators (e.g., hypertension)
- •Participants with a known balance or gait disorder
- •Participants with color blindness (Phase 2 only)
- •Participants who currently wear hard contact lenses for vision correction (Phase 2 only)
- •Participants who have donated 450 mL or more of blood in the two weeks prior to study enrollment
- •Participants who are pregnant or breastfeeding (female participants only)
- •Participants who report never using cannabis before in their lifetime (Phases 1 & 2 only)
- •Participants with a history of clinically significant adverse event(s) associated with cannabis intoxication (e.g., lightheadedness, nausea, dizziness, etc., cannabis use groups only)
- •Participants with uncorrected visual acuity disorder, defined as binocular vision worse than 20/40 (Phases 2, 3 & 4 only; determined at screening)
- •Participants with a body mass index >40 kg/m2 (determined at screening)
- •Participants with a positive breath alcohol test (breathalyzer) at screening
- •Participants who are otherwise unsuitable for inclusion in the study, based on the opinion of the investigator
结局指标
主要结局
Driving Impairment
时间窗: 5 years
SDLP (standard deviation of lateral position) is measured by our Advanced NADS minisim
次要结局
未报告次要终点
研究者
Ashley Brooks-Russell
Associate Professor, Director (Injury and Violence Prevention Center)
Colorado School of Public Health
研究点 (1)
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