Evaluation of Smoked THC and CBD in Oral Fluid, Pharmacokinetics, and Subjective and Neurocognitive Effects in Men and Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Subjective drug effect ratings of impairment and abuse liability
研究概览
简要总结
The purpose of this study is to determine the pharmacokinetics and pharmacodynamics of inhaled cannabis with varying amounts of delta-9-tetrahydrocannabinol (THC), and cannabidiol (CBD) and to evaluate detection of recently smoked THC in oral fluid.
详细描述
This double-blind placebo controlled, within-subject study study will assess testing devices that can measure biochemical markers in oral fluid and neurocognitive-performance markers of recent cannabis use. Other pharmacodynamic effects of inhaled cannabis with CBD and THC will be determined and the pharmacokinetics of THC, CBD, and respective metabolites will be assessed in whole blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or non-pregnant and non-lactating females aged 21-55 years
- •Report weekly-monthly use of cannabis (≤1 day per week) over the past month prior to screening,
- •Not currently seeking treatment for their cannabis use
- •Have a Body Mass Index from 18.5 - 34kg/m
- •Able to perform all study procedures
- •Must be using a contraceptive (hormonal or barrier methods)
排除标准
- •Meeting DSM-V criteria for moderate to severe Cannabis Use disorder (CUD) or any substance use disorder other than nicotine, caffeine
- •Any other Axis I disorder
- •Report using other illicit drugs in the prior 4 weeks, other than cannabis.
- •Current use of any medications that may affect study outcomes
- •If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process are not within the normal range and / or reveal any significant illness (e.g., hypertension) as judged by the study physician and to put the participant at greater risk of experiencing adverse events due to completion of study procedures.
- •Pregnancy is exclusionary due to the possible effects of the study medication on fetal development.
- •History of an allergic reaction or adverse reaction to cannabis is exclusionary.
- •History of respiratory illness or current respiratory illness
- •Currently enrolled in another research protocol
- •Not using a contraceptive method (hormonal or barrier methods)
- •The evaluating physician reviews all medical assessments along with medical history. Any disorders that might make cannabis administration hazardous are exclusionary.
研究组 & 干预措施
Placebo
Smoked placebo cannabis
干预措施: Placebo Cannabis (Drug)
20 mg CBD
Smoked cannabis with CBD
干预措施: 20 mg CBD Cannabis (Drug)
20 mg CBD + 20 mg THC
Smoked cannabis with CBD and THC
干预措施: 20 mg CBD + 20 mg THC Cannabis (Drug)
20 mg THC
Smoked cannabis with THC
干预措施: 20 mg THC Cannabis (Drug)
结局指标
主要结局
Subjective drug effect ratings of impairment and abuse liability
时间窗: 6 hours
Peak subjective ratings of drug effects associated with abuse liability and impairment as measured using visual analogue scales (VAS; 1-100mm).
Behavioral task performance as assessed by the DRUID App Score
时间窗: 6 hour
Trough composite scores on the DRUID App
Pharmacokinetics of THC, CBD and metabolites
时间窗: 6 hours
Peak blood levels of THC, CBD, 11-OH-THC, and THCCOOH after exposure (Tmax)
THC concentrations in oral fluid
时间窗: 6 hour
Peak levels of THC in oral fluid after exposure
次要结局
未报告次要终点
研究者
Ziva D. Cooper, PhD
Associate Professor
University of California, Los Angeles