Pharmacokinetic and Pharmacodynamic Effects of Oral Cannabis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Oral Fluid THC
研究概览
简要总结
Few studies have been conducted to assess the pharmacokinetic and pharmacodynamic effects of orally consumed intact cannabis (e.g., cannabis-containing brownies). Careful analysis of oral cannabis dose effects on these parameters is required to determine the level and duration of biological cannabinoid exposure and associated subjective, cardiovascular and cognitive effects. In the present study we evaluated the detection of cannabinoids in oral fluid, plasma, hair, and urine for up to 9 days following consumption of oral cannabis (10mg, 25mg, or 50mg THC). The outcomes of the study will extend scientific knowledge about the behavioral pharmacology and toxicology of oral cannabis administration and can inform policies regarding clinical, workplace and roadside drug testing programs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have provided written informed consent
- •Be between the ages of 18 and 45
- •Be in good general health based on a physical examination, medical history, vital signs, 12-lead ECG and screening urine and blood tests
- •Test negative for recent cannabis use in urine at the screening visit (confirmed by GC/MS laboratory test) and at clinic admission
- •Test negative for other drugs of abuse, including alcohol at the screening visit and at clinic admission
- •Demonstrate ability to expectorate 3-5 mL of "native" oral fluid over a 5-minute period
- •Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission.
- •Have a body mass index (BMI) in the range of 19 to 36 kg/m2
- •Have head hair that is at least 4 cm (approximately one and a half inches) in length on the back of the head.
- •Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg
- •Have no allergies to any of the ingredients used to prepare cannabis brownies (chocolate, eggs, wheat, etc.).
排除标准
- •Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine 3 month prior to the Screening Visit;
- •History of or current evidence of significant medical or psychiatric illness judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures.
- •Use of an OTC, systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
- •Use of a prescription medication (with the exception of birth control prescriptions) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
- •Use of hemp seeds or hemp oil in any form in the past 3 months.
- •Use of dronabinol (Marinol) within the past 6 months.
- •History of xerostomia (dry mouth), or the presence of mucositis, gum infection or bleeding, or other significant oral cavity disease or disorder that in the investigator's opinion may affect the collection of oral fluid samples.
- •History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
- •Abnormal EKG result that in the investigator's opinion is clinically significant.
- •Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.
研究组 & 干预措施
10mg acute oral cannabis
10mg acute oral cannabis
干预措施: Oral cannabis (Drug)
25mg acute oral cannabis
25mg acute oral cannabis
干预措施: Oral cannabis (Drug)
50mg acute oral cannabis
50mg acute oral cannabis
干预措施: Oral cannabis (Drug)
结局指标
主要结局
Oral Fluid THC
时间窗: baseline and 0.2, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 22, 26, 30, 34, 46, 50, 54, 58, 70, 74, 78, 82, 94, 98, 102, 106, 118, 122, 126, and 130 hours post exposure
Urine THC-COOH
时间窗: Baseline and 1, 2, 3, 4, 4-6 hours, 6-8 hours, 8-10 hours, 10-12 hours and then every 4 hours up until the 130 hour post exposure time point
Subjective rating of "Drug Effect"
时间窗: baseline, immediately after exposure and 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post exposure
Visual analog scale ratings of subjective intoxication
Blood THC
时间窗: baseline and 0.2, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 22, 26, 30, 34, 46, 50, 54, 58, 70, 74, 78, 82, 94, 98, 102, 106, 118, 122, 126, and 130 hours post exposure
次要结局
未报告次要终点
研究者
Ryan Vandrey
Associate Professor
Johns Hopkins University