Differences in Cannabis Impairment and Its Measurement Due to Route of Administration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Tetrahydrocannabinol (THC) Concentration in Blood
研究概览
简要总结
This research is being done to measure the effects of both oral and vaporized cannabis (marijuana), at different doses, on the ability to perform certain tasks such as balancing, eye tracking, and computerized measures of memory and attention, as well as performance on a novel app (DRUID) that is being developed for field sobriety testing. The investigators will collect biological fluids (urine, blood, saliva/spit) after cannabis is eaten or vaporized to see if there are markers in those fluids that can predict performance on the behavioral tasks and the DRUID App. The results of this study will help us better understand the effects of using cannabis, and to help identify behaviors and/or substances in the body that relate to cannabis impairment.
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, Outcomes Assessor)
盲法说明
Placebo controlled, double blind drug administration
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
- •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 Gas Chromatography (GC)/ Mass Spectrometry (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
- •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.).
- •Report prior experience inhaling cannabis (either via smoking or vaporization).
排除标准
- •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 Over-the-Counter (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.
- •Epilepsy or a history of seizures.
- •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
High-Dose Vaporized Cannabis
Single acute administration of placebo cannabis containing 20mg THC via commercial vaporizer
干预措施: cannabis (Drug)
Placebo Oral Cannabis
Single acute administration of placebo cannabis baked into a brownie
干预措施: cannabis (Drug)
Low-Dose Oral Cannabis
Single acute administration of cannabis containing 10mg THC baked into a brownie
干预措施: cannabis (Drug)
High-Dose Oral Cannabis
Single acute administration of cannabis containing 25mg THC baked into a brownie
干预措施: cannabis (Drug)
Placebo Vaporized Cannabis
Single acute administration of placebo cannabis via commercial vaporizer
干预措施: cannabis (Drug)
Low-Dose Vaporized Cannabis
Single acute administration of placebo cannabis containing 5mg THC via commercial vaporizer
干预措施: cannabis (Drug)
结局指标
主要结局
Tetrahydrocannabinol (THC) Concentration in Blood
时间窗: 8 hours
Quantitation of active drug (THC) in whole blood (ng/ml).
次要结局
- 11-hydroxy-tetrahydrocannabinol (11-OH-THC)(8 hours)
- Tetrahydrocannabinolic Acid (THCCOOH)(8 hours)
- Peak Change in Blood Pressure(8 hours post drug exposure)
- Change in Heart Rate(Baseline, 1, 2, 3, 4, 5, 6, 7, and 8 hours post drug exposure)
- Mean (SD) Peak Change-from-baseline Drug Effect Rating(Up to 5 hours)
- Change From Baseline Behavioral Task Performance as Assessed by the DRUID App Score(8 hours)