Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Mean Nicotine Exposure Over Time
研究概览
简要总结
In a crossover study, experienced electronic cigarette users will vape 3 different forms of nicotine: natural (derived from tobacco), synthetic, or a 50:50 mixture of both natural and synthetic. The investigators will compare nicotine metabolism, cardiovascular effects, patterns of self-administration, and participants' feelings of craving/withdrawal and enjoyment.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy on the basis of medical history and limited physical examination.
- •Current regular user of E-Cigarettes (≥ 15 days in the past 30 days)
排除标准
- •• Medications
- •Use of medications that are inducers of nicotine metabolizing enzyme CYP2A6 (Example: rifampicin, carbamazepine, phenobarbital, and other anticonvulsant drugs).
- •Use of sympatholytic medications for cardiovascular conditions including hypertension (Example: beta and alpha-blockers).
- •Concurrent use of nicotine-containing medications (Example: nicotine patch, lozenge, gum).
- •Any stimulant medications (example: Adderall) generally given for ADHD treatment.
- •Pregnancy
- •Pregnancy (self-reported and urine pregnancy test)
- •Breastfeeding (determined by self-report)
- •Women of childbearing potential must be using an acceptable method of contraception
- •Inability to read and write in English
- •A known propylene glycol/vegetable glycerin allergy
- •Uncomfortable with getting blood drawn
研究组 & 干预措施
S-nicotine (tobacco) as the starting condition
Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 100% (S)-nicotine.
干预措施: (S)-Nicotine (Drug)
Racemic (50:50 S- and R- nicotine) as the starting condition
Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 50% (S)-nicotine and 50% (R)-nicotine.
干预措施: (R)- nicotine (Drug)
S-nicotine (tobacco) as the starting condition
Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 100% (S)-nicotine.
干预措施: (R)- nicotine (Drug)
S-nicotine (tobacco) as the starting condition
Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 100% (S)-nicotine.
干预措施: Racemic nicotine (Drug)
R-nicotine (synthetic) as the starting condition
Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 100% (R)-nicotine.
干预措施: (S)-Nicotine (Drug)
R-nicotine (synthetic) as the starting condition
Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 100% (R)-nicotine.
干预措施: (R)- nicotine (Drug)
R-nicotine (synthetic) as the starting condition
Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 100% (R)-nicotine.
干预措施: Racemic nicotine (Drug)
Racemic (50:50 S- and R- nicotine) as the starting condition
Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 50% (S)-nicotine and 50% (R)-nicotine.
干预措施: (S)-Nicotine (Drug)
Racemic (50:50 S- and R- nicotine) as the starting condition
Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 50% (S)-nicotine and 50% (R)-nicotine.
干预措施: Racemic nicotine (Drug)
结局指标
主要结局
Mean Nicotine Exposure Over Time
时间窗: Up to 7 hours
Plasma nicotine area under the concentrated time curve (AUC) (ng/ml\*h)
次要结局
- Mean Amount of Nicotine Consumed Over Time(120 minutes)