Effects of Cannabis Administration Routes on Human Performance and Pharmacokinetics
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Cannabis' pharmacokinetic profiles
研究概览
简要总结
Background:
- Marijuana (cannabis) is an illegal drug. Researchers want to study people s reactions, attention, and behavior after they take marijuana in different ways. They want to learn better ways to detect drugs in a person s body They also want to know how long marijuana can be found in blood, urine, saliva, and breath.
Objectives:
- To learn how people respond to delta-9-tetrahydrocannabinol (THC, a marijuana component) and how their bodies handle it after it is given in different ways.
Eligibility:
- Adults age 18 50 who use marijuana.
Design:
- Participants are screened under another NIDA protocol.
- This study involves up to 6 visits to NIDA.
- At the first visit, participants will practice the tasks and tests they will do at their dosing sessions. They will learn how to give breath and saliva samples.
- Dosing sessions 1 4 will last 3 5 days each. All participants will be admitted to a research clinic the night before these sessions. Some participants can stay at the clinic and some must go home between sessions.
- At each session, participants will eat a brownie with placebo or marijuana. Then they will smoke a placebo or marijuana cigarette. Some will inhale placebo or marijuana after it is vaporized.
- Throughout the sessions:
- Participants will give urine, saliva, and breath samples. Their blood will be taken with a tube in a vein and finger pricks. Their vital signs will be checked.
- Participants will answer questionnaires and take thinking tests. They will also take tests that assess eye movement, balance, and time estimation.
- Participants may have a 5th dosing session. They will eat a marijuana brownie and have the above tests and samples.
详细描述
Objectives
Cannabinoids are most commonly administered via smoking. Oral consumption in medications, teas, oils, or food also is widely utilized. Additionally, cannabis vaporization followed by inhalation for medical and illicit administration is common. Differences in cannabis pharmacodynamics and pharmacokinetics between these three administration routes and in occasional and frequent cannabis smokers are not thoroughly characterized. This study evaluates cannabis pharmacodynamics and pharmacokinetics in occasional and frequent smokers after smoked, vaporized, and oral cannabis administration.
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Study Population
Up to 80 healthy cannabis smokers, aged 18-50, without a history of adverse reactions to cannabis will be recruited. For dosing sessions 1-4, ten occasional smokers (smoking frequency greater than or equal to 2 times/month but <3 times/week) and ten frequent smokers (smoking frequency generally greater than or equal to 5times/week) are required. For the optional 5th session, 8-20 participants (regardless of smoking history) are required.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
干预措施: Placebo + Smoked Cannabis (Drug)
2
干预措施: Placebo + Inhaled Cannabis (Drug)
3
干预措施: Oral Cannabis + Placebo (Drug)
4
干预措施: Placebo + Placebo (Drug)
5
干预措施: 6.9% cannabis oral (Drug)
结局指标
主要结局
Cannabis' pharmacokinetic profiles
时间窗: Multiple times daily
Cannabis' pharmacodynamic effects
时间窗: Multiple times daily
Pharmacokinetic/Dynamic Modelling
时间窗: Once
Cannabis oral fluid cutoff evaluation
时间窗: Once
次要结局
- Cannabinoid stability in oral fluid(Multiple times)
- Cannabis urine cutoff evaluation(Once)
- Cannabis' effects on appetitive peptides(Multiple times daily)
- Cannabinoid stability in dried blood(Multiple times)
- Pharmacokinetic/Dynamic Modelling(Multiple times)
- Compare on-site oral fluid devices(Once)