临床试验/NCT00625794

NCT00625794已完成4 期

A Randomized Trial of the Nicotine Nasal Spray in Adolescent Smokers

University of California, San Francisco1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2005年9月最近更新: 2008年2月28日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: University of California, San Francisco
入组人数: 40
试验地点: 1
主要终点: Self-reported smoking abstinence verified by both expired-air carbon monoxide and salivary cotinine.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of this pilot study is to determine the feasibility and utility of using the nicotine nasal spray (NNS) in adolescent smokers who want to quit smoking.

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: None

入排标准

年龄范围: 15 Years 至 18 Years（Child, Adult）
性别: All
接受健康志愿者: 是

入选标准

•Be between 15 and 18 years-old
•Smoke 5 or more cigarettes per day (cpd) for at least 6 months and want to quit smoking.

排除标准

•Adolescents who were using or had used nicotine replacement in the prior week were excluded.
•Those who used bupropion (Zyban®) within the past 30 days were also excluded.

研究组 & 干预措施

1

Experimental

8 weeks or counseling plus 6 weeks of nicotine nasal spray

干预措施: Nicotine nasal spray (Drug)

2

Active Comparator

8 weeks or counseling only.

干预措施: Smoking cessation counseling (Behavioral)

结局指标

主要结局

Self-reported smoking abstinence verified by both expired-air carbon monoxide and salivary cotinine.

时间窗: 12 weeks

次要结局

Acceptability of the Nicotine Nasal Spray by Adolescents.(8 weeks)

研究者

发起方

University of California, San Francisco

申办方类型

Other

研究点 (1)

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