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临床试验/NCT01866722
NCT01866722已完成不适用

A Test of Two Clinical Methods to Prompt a Quit Attempt Among Smokers

University of Vermont2 个研究点 分布在 1 个国家目标入组 560 人开始时间: 2013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
560
试验地点
2
主要终点
quit attempts

研究概览

简要总结

In our communications with the public, the investigators will call this the Not Quite Ready to Quit Smoking Study.

One new method to increase quit attempts is to have smokers reduce their cigs/day. The investigators and others have shown that reduction aided by nicotine medications can increase quit attempts and later abstinence among smokers not ready to quit. Because half of smokers are reluctant to use nicotine medications for a non-cessation reason, the investigators now propose to test whether reduction not aided by nicotine medications can be effective. Another new method to increase quit attempts is motivational counseling. The investigators previously found implementation of the brief United States Public Health Service (USPHS) Guidelines 5 Rs motivational intervention via three 15 min phone calls can provide a large increase in quitting (OR = 6.3); however, the investigators need to replicate that result. A vendor will proactively email adult, daily smokers listed in a consumer panel to recruit 560 smokers who do not plan to quit in the next month and randomize them to a) reduction counseling without the aid of nicotine medications , b) brief counseling guided by the USPHS 5 R's, or c) usual care. The first two conditions will be delivered via brief counseling calls at study onset and then 2 and 4 weeks later (total = 35 min). The usual care condition will consist of a brief (< 5 min) phone intervention followed by a quit guide. Our major hypothesis is that the incidence of quit attempts over the 6 months of the study will be greater in both the reduction and the motivational conditions than in the usual care condition. A secondary hypothesis is that the increase in quit attempts will lead to increased abstinence. Another secondary hypothesis is that beneficial effects of both treatments will be mediated by increases in self-efficacy and intentions to quit. A final hypothesis is that decreases in cigs/day and nicotine dependence will mediate the efficacy of the reduction treatment but not the motivational treatment and, conversely, that a shift in decisional balance will mediate the efficacy of the motivational treatment but not of the reduction treatment.

详细描述

Objectives

Among smokers who wish to quit at some time but do not plan to quit in the next month:

Major Hypotheses

Major Hypothesis 1: A treatment to reduce cigs/day that does not include nicotine replacement therapy (NRT) will increase the incidence of a quit attempt (yes/no outcome).

Major Hypothesis 2: A motivational treatment based on the USPHS's 5 Rs will increase the incidence of a quit attempt (yes/no outcome)

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

  • > 18 years old
  • smoke > 10 cigs/day seven days/week,
  • wants to stop at some point but have no plans to quit in the next month
  • is able to read and write English
  • is a US citizen or a permanent resident alien
  • available for counseling calls before 20:00 Eastern Time

排除标准

  • has reduced cigs/day by > 25% in the last month
  • has used non-cigarette tobacco in the last month
  • has used electronic cigarettes, nicotine replacement medications, varenicline or bupropion in the last month

结局指标

主要结局

quit attempts

时间窗: About 2 years

The incidence of an attempt to quit smoking tobacco cigarettes during the 6 months of the study.

次要结局

  • abstinence(About 2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John Hughes

Principal Investigator

University of Vermont

研究点 (2)

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