High Confusion: Evaluating Effects of Popular Cannabis Isolates on Driving Performance
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Quantify analyte concentrations
研究概览
简要总结
This study is being done to assess the feasibility of administrating Δ9-THC and Δ8-THC isolates and simultaneously adopting several data harmonization measures to generate uniquely translatable data. This project aims to (1) evaluate the feasibility and acceptability of administering ∆9-THC and Δ8-THC isolates using standardized cannabis dosing units to quantify ∆9-THC and Δ8-THC pharmacokinetics; and (2) evaluate the feasibility and acceptability of adopting standardized impairment detection methods and driving performance definitions and measures on quantifying ∆9-THC and Δ8-THC driving impairment compared to a placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age, no older than 49 years of age
- •Recent cannabis use (within past two years)
- •Good mental health as determined by self-reported responses to the Psychopathology Screener
- •Absence of any major medical, cardiovascular, endocrine, and neurological condition as determined by self-reported responses to the Medical History Screener
- •In possession of a valid drivers' license with at least two years of driving experience
- •English-speaking (able to provide consent and complete questionnaires)
- •Written Informed Consent
排除标准
- •Any serious prior adverse response to cannabis
- •History of or current substance use disorder as determined by self-reported responses to the Internalizing, Externalizing, and Substance Use Disorder Screener
- •Pregnancy or lactation (pregnancy test, if needed)
- •Use of medications that may impact driving ability (e.g., mood stabilizers, sedatives)
研究组 & 干预措施
delta-9-THC
干预措施: Delta-9-THC (Drug)
delta-8-THC
干预措施: Delta-8-THC (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Quantify analyte concentrations
时间窗: 9 months
Quantify delta-9-THC, delta-8-THC, and their primary metabolites in whole blood, plasma, oral fluid, and dried blood spots at several time points before and after acute study drug administration.
Quantify impairing effects of cannabinoids
时间窗: 9 months
Quantify the impairing effects of delta-9-THC and delta-8-THC by measuring the standard deviation of lateral position within the driving simulation and by completing a drug recognition expert field sobriety test for signs of impairment.
次要结局
未报告次要终点