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临床试验/NCT00706979
NCT00706979已完成不适用

A Novel Treatment to Boost Quit Attempts and Cessation Among Unmotivated Smokers

Medical University of South Carolina0 个研究点目标入组 849 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
849
主要终点
A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking

研究概览

简要总结

A sample of smokers who have no current plans to quit will be recruited for this study and randomized to one of two intervention conditions:

  1. Practice Quit Attempt (PQA) aided by brief advice and self-help materials, or
  2. PQA aided by advice and self-help materials plus nicotine replacement therapy (NRT).

This study will test whether adding free nicotine replacement therapy to brief advice to undertake a practice quit attempt will motivate more smokers to make a serious attempt to stop smoking than brief advice without NRT. All treatments and assessments will be delivered via telephone and mailing. The primary outcome of interest is the incidence of a serious attempt to permanently stop smoking made over a six-month study period.

Our specific hypotheses are as follows:

Hypothesis 1: Helping smokers to make a practice quit attempt aided by NRT will result in a higher incidence of making a serious effort to quit smoking permanently, compared to an aided practice quit attempt without NRT. We also expect provision of NRT will increase point prevalence abstinence at 6 month follow-up.

Hypothesis 2: This relationship between NRT-aided practice quit attempts and quit behaviors will be mediated by a) increased smoking related self efficacy, b) increased belief in the efficacy of NRT, c) fewer concerns about adverse events of NRT, d) increased social support for not smoking, and e) less withdrawal distress and craving during the practice quit attempt.

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

入选标准

  • Current cigarette smoker of at least 10 cigarettes per day
  • Interested in quitting at some time
  • Not currently interested in quitting smoking
  • Access to telephone (home or work) for 6 month study period

排除标准

  • Monthly cigar, pipe, or smokeless tobacco use
  • Current pregnancy or breastfeeding
  • Recent cardiovascular distress
  • Phenylketonuria (PKU)
  • Previous use of nicotine replacement therapy (gum, patch, lozenge, inhaler, or nasal spray)

结局指标

主要结局

A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking

时间窗: From study enrollment through six month follow-up

The primary outcome was an attempt to quit smoking for good. To distinguish from a PQA, we specifically asked participants if they tried to quit smoking with the intent of quitting for good. Quit attempts were defined as any self-defined attempt to quit for good.

A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking

时间窗: From study enrollment through six month follow-up

Serious quit attempt of \>=24hrs, which fits the CDC's definition of a quit attempt.

次要结局

  • Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days(At 6-month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

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