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临床试验/NCT01374724
NCT01374724Unknown不适用

Preventing Relapse Following Involuntary Smoking Abstinence

University of Tennessee4 个研究点 分布在 1 个国家目标入组 23,000 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
23,000
试验地点
4
主要终点
Smoking cessation maintenance

研究概览

简要总结

The prevalence of tobacco use in the military is too high. This study is designed to take advantage of the 8.5 weeks of forced tobacco cessation during Basic Military Training and develop effective interventions to prevent tobacco relapse.

Hypotheses or Research Questions:

  • Are there differences in the rate of relapse between three groups participating in a tobacco abstinence maintenance intervention?
  • Do the tobacco abstinence maintenance interventions delay relapse?

详细描述

Consented subjects will be randomly assigned either to:(a) National Cancer Institute tobacco cessation pamphlet , to (b) Tailored relapse prevention pamphlet , or to (c) Tailored relapse prevention pamphlet + 1 proactive relapse prevention face-to-face meeting.

To determine the long-term (12 month) efficacy of the abstinence maintenance intervention. Our primary outcome is abstinence from tobacco products at the 12 month follow-up. A secondary outcome will be to determine if these interventions delay relapse among those who relapse to smoking or other tobacco use.

Significance: Cigarette smoking use is the number one preventable cause of morbidity and mortality in this nation (CDC, 1999; Mokdad et al., 2004). Preventing relapse is a high priority for those attempting to quit smoking as most people who attempt cessation relapse within a very short period of time (Fiore et al., 2000). Of smokers who receive a formal cessation program, at least 70% relapse (Fiore et al., 2000); among self quitters, the relapse rate is approximately 90% (Cohen et al., 1989). It is still the case, however, that the vast majority of smokers who try to stop smoking do so with no or with minimal assistance (Garvey et al., 1992).

While the vast majority of smokers try to quit on their own, surprisingly little research has been conducted on reducing relapse among self-quitters. Brandon and colleagues (2000, 2003, 2004) have demonstrated that a series of 8 self-help printed materials consistently produced higher point-prevalence abstinence rates in smokers that had quit on their own. Given the enormous public health implications of this approach, more research on promoting long-term self-quitting is clearly needed. In addition a number of never smokers actually start smoking shortly after accession into the Air Force (Klesges et. al., 1999; 2006). The goal of this research is to encourage all airmen to remain tobacco free. Because of this the investigators are encouraging all airmen to participate in the abstinence maintenance interventions.

Military Relevance: Virtually all research to date on promoting self-quitting has been conducted in samples where participants have voluntarily stopped smoking prior to participating in the interventions (Brandon et al., 2000, 2004). However, nothing is known about methods of preventing and delaying initiation following involuntary abstinence (e.g., military training, during hospital stays, in jails, prisons, & psychiatric facilities). Previous research (Klesges et al., 1999, 2006) has determined that protracted involuntary cessation in the military with no other intervention is associated with significant long-term cessation rates (15-20% at a one-year follow-up). To our knowledge, no study has successfully intervened to reduce relapse rates following a protracted involuntary abstinence (such as in Basic Military Training).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Active duty Air Force personnel
  • Has smoked five or more cigarettes per day for at least 1 year before study entry

排除标准

  • 未提供

结局指标

主要结局

Smoking cessation maintenance

时间窗: 12 month follow-up

Subjects will be called at one year post intervention to determine self-report of tobacco use status.

次要结局

  • Delayed relapse among those who relapse to tobacco use(12 month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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