The Effects of Sedatives on Tobacco Use Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Side Effects
研究概览
简要总结
This proposal will obtain preliminary data on the effect of a single sub-anesthetic dose of a sedative on cigarette craving and smoking behavior as well as measuring tolerability and acceptability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
single-blind
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •smoke at least 5 cigarettes per day
- •smoked at least 2 years
- •negative urine drug screen for psychoactive drugs and negative breath alcohol concentration
- •live in Little Rock AR or surrounding area
排除标准
- •unstable or stable medical condition that would interact with study medication or participation
- •serious head trauma or neurological disorder
- •hypertension, abnormal ECG or metabolic blood results
- •meet criteria for psychosis, schizophrenia, major depressive disorder, or bipolar disorder
- •use of psychoactive drugs or medications
- •BMI > 40
- •among women, pregnancy or breastfeeding
研究组 & 干预措施
ketamine intravenous infusion
single ketamine infusion (0.5 mg/kg over 20 minutes)
干预措施: ketamine intravenous infusion (Drug)
midazolam intravenous infusion
single midazolam infusion (0.02 mg/kg over 20 minutes)
干预措施: midazolam intravenous infusion (Drug)
placebo intravenous infusion
single placebo infusion (saline over 20 minutes)
干预措施: placebo intravenous infusion (Drug)
结局指标
主要结局
Side Effects
时间窗: about 1 week post infusion
drug side effects scale: severity scale from 1 (not at all) to 7 (extremely) for symptoms of nausea, dizziness, sleepiness, strange thoughts, hallucinations, confusion, anxiousness, and headache. The average score across all side effects is reported.
次要结局
未报告次要终点