NCT01781234已完成2 期
Efficacy Study of Intranasal Insulin to Treat Tobacco Abstinence Syndrome
Ajna Hamidovic1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Salivary Cortisol
研究概览
简要总结
This study will evaluate safety and efficacy of intranasal insulin in abstinent smokers. Groups' (placebo vs. insulin) cognitive function and stress response will be compared.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •smokers (>10 cig/day) for the past 1 year
- •normosmic olfactory function
排除标准
- •previous/current use of insulin
- •current Diagnostic and Statistical Manual-IV-Revised (DSM-IV-R) Axis I disorder
- •current pregnancy (or lactation)
- •lifetime history of endocrine disease
- •excessive alcohol use (>25 standard units of alcohol/week)
- •current use of illicit drugs
- •current use of a smoking cessation aid (NRT, Chantix or Wellbutrin), or a psychotropic agent
- •local infections, inflammation, structural abnormalities, or other nasal pathology
- •current use of any medications administered intranasally, including intranasal steroids
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
Intranasal Insulin
Experimental
Intranasal Insulin
干预措施: Intranasal Insulin (Drug)
结局指标
主要结局
Salivary Cortisol
时间窗: 90 minutes
Episodic Memory
时间窗: 90 minutes
California Verbal Learning Task Number of Words Learned Higher Values Mean Better Outcome
次要结局
未报告次要终点
研究者
Ajna Hamidovic
Assistant Professor
University of New Mexico
研究点 (1)
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