The Pharmacokinetics, Safety, and Ease of Use of a Portable Metered-Dose Cannabis Inhaler: A Phase 1a Study
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 12
- 主要终点
- Δ9 Carboxy-THC levels
研究概览
简要总结
Growing evidence supports the use of inhaled cannabis for neuropathic pain; the lack of standard inhaled dosing holds a major obstacle in cannabis becoming a pharmacological treatment for neuropathic pain. The objective of this study is to explore the pharmacokinetics, safety, tolerability, and ease of use of a portable metered-dose inhaler, (i.e. CannaHALER) for cannabis in a cohort of 12 healthy volunteers. In a single escalating dose methodology, open-label study, patients will inhale a single 10 ± 0.1 mg / 15 ± 0.1 mg / 20 ± 0.1 mg / 25 ± 0.1 mg dose of cannabis using the Kite Systems cannaHALER cannabis Inhaler device. Blood samples will be taken at baseline and up to 30 minutes. Adverse events will be monitored following the inhalation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 30-70 years;
- •if applicable, negative pregnancy test (β human chorionic gonadotropin pregnancy test).
排除标准
- •significant cardiac or pulmonary disease,
- •history of a psychotic or anxiety disorder,
- •pregnancy, pregnancy attempt or breastfeeding,
- •presence of a neuropathic or non-neuropathic pain,
- •low blood pressure, below 90 mm Hg (systolic)
- •Diabetes is diagnosed,
- •first degree family history of psychotic or anxiety disorder,
- •history of drug addiction,
- •history of drug misuse,
- •using the following drugs: Rifampicin, Rifabutin, Carbamazepine, Phenobarbital, Primidone,
- •using the following plants: Hypericum perforatum, troglitazone,
- •Alcohol consumption up to 12 hours before the study,
- •abnormal parameters such as Heart Rate above 100 BPM, Blood pressure, below 90 mm Hg (systolic), Saturation below 91 percent,
- •Cannabis use up to 12 hours before the study,
- •health condition which could affect or alter the experiment results,
- •Volunteer has a legal guardian.
- •Chronic use of drugs,
- •age less than 30 or more than 70,
- •a health condition that could affect the outcome of the trial or constitutes a risk factor for participation in the trial.
- •The experiment will not include special populations such as pregnant women, children and without judgement.
研究组 & 干预措施
Single CannaHALER dose 10 ± 0.1 mg
Single dose 10 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device.
干预措施: Kite Systems cannaHALER cannabis Inhaler. (Drug)
Single CannaHALER dose 15 ± 0.1 mg
Single dose 15 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device.
干预措施: Kite Systems cannaHALER cannabis Inhaler. (Drug)
Single CannaHALER dose 20 ± 0.1 mg
Single dose 20 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device.
干预措施: Kite Systems cannaHALER cannabis Inhaler. (Drug)
Single CannaHALER dose 25 ± 0.1 mg
Single dose 25 ± 0.1 mg of cannabis using the Kite Systems CannaHALER cannabis Inhaler device.
干预措施: Kite Systems cannaHALER cannabis Inhaler. (Drug)
结局指标
主要结局
Δ9 Carboxy-THC levels
时间窗: 30 Minutes
Δ9-tetrahydrocannabinol levels (THC)
时间窗: 30 Minutes
Adverse event monitoring
时间窗: 4 hours
次要结局
- Short Blessed cognitive Test(30 Minutes)
- Blood pressure(120 Minutes)
- Pulse rate(120 Minutes)
- Oxygen saturation(120 Minutes)