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临床试验/NCT02562521
NCT02562521已完成4 期

A Smoking Cessation Intervention for Yale Dining Employees

Yale University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
25
试验地点
1
主要终点
Number of Participants With a Smoking Quit Attempt in the Prior Six Weeks

研究概览

简要总结

The purpose of this study is to evaluate a smoking cessation program for employees at the Yale University dining hall. Two pilot dining halls and six paired dining halls (3 test and 3 control sites) will be offered a contingency management/pharmacotherapy smoking cessation intervention at the work site.

详细描述

The primary aim of this study is to test the effect of a smoking cessation intervention provided to Yale University dining hall employees on smoking quit rates and quit attempts at the end of six weeks of treatment. It is hypothesized that participants from the test site will have higher rates of smoking cessation and quit attempts compared to participants from the control site. In addition, this study will examine the number of participants who enroll in the smoking cessation program who successfully quit smoking at 6 months.

There will be 3 test sites and 3 control sites in this study (broken down into 3 pairs of test/control). Each test site will be matched to on a control site. Self-reported smoking status will be obtained for all participants in the test and control sites at 3 time points (baseline, 6 weeks and 6 months). The study start time for each pair will be delayed by 4-8 weeks for feasibility issues.

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 smoker
  • Interested in receiving treatment for quitting smoking.
  • Employed for more than 20 hours per week by one of the 7 residential college dining halls selected for inclusion in this study.
  • English speaker.

排除标准

  • None specified, other than failure to meet all inclusion criteria listed above.

研究组 & 干预措施

Smoking Cessation Treatment

Experimental

The intervention will consist of Contingency management (CM) in conjunction with effective first line pharmacotherapy (dual nicotine replacement therapy [NRT] or varenicline) and brief counseling to rapidly induce cessation and to maintain abstinence long term. Pharmacotherapy will be flexible. Participants will also be given the option of receiving additional behavioral support by being referred to the CT Quitline and using text or mobile phone apps for quitting.

干预措施: Contingency management (Behavioral)

Smoking Cessation Treatment

Experimental

The intervention will consist of Contingency management (CM) in conjunction with effective first line pharmacotherapy (dual nicotine replacement therapy [NRT] or varenicline) and brief counseling to rapidly induce cessation and to maintain abstinence long term. Pharmacotherapy will be flexible. Participants will also be given the option of receiving additional behavioral support by being referred to the CT Quitline and using text or mobile phone apps for quitting.

干预措施: Nicotine replacement therapy (Drug)

Smoking Cessation Treatment

Experimental

The intervention will consist of Contingency management (CM) in conjunction with effective first line pharmacotherapy (dual nicotine replacement therapy [NRT] or varenicline) and brief counseling to rapidly induce cessation and to maintain abstinence long term. Pharmacotherapy will be flexible. Participants will also be given the option of receiving additional behavioral support by being referred to the CT Quitline and using text or mobile phone apps for quitting.

干预措施: Varenicline (Drug)

Smoking Cessation Treatment

Experimental

The intervention will consist of Contingency management (CM) in conjunction with effective first line pharmacotherapy (dual nicotine replacement therapy [NRT] or varenicline) and brief counseling to rapidly induce cessation and to maintain abstinence long term. Pharmacotherapy will be flexible. Participants will also be given the option of receiving additional behavioral support by being referred to the CT Quitline and using text or mobile phone apps for quitting.

干预措施: Additional behavioral support (Behavioral)

结局指标

主要结局

Number of Participants With a Smoking Quit Attempt in the Prior Six Weeks

时间窗: 6 weeks

A survey of dining hall employees will be used to determine the proportion of the dining hall employees who made a quit attempt in the prior six weeks in the treatment and delayed treatment control groups. Values present the proportion of dining hall employees who smoke who reported making a quit attempt.

Number of Participants Who Quit Smoking for at Least 24 Hours in the Prior Six Weeks

时间窗: 6 weeks

A survey of dining hall employees will be used to determine the proportion of the dining hall employees who quit smoking for at least 24 hours in the prior six weeks in the treatment and delayed treatment control groups. Values present the number of individuals who report quitting successfully for at least 24 hours among individuals who reported smoking.

次要结局

  • Number of Participants Who Quit Smoking at 3 Months(Month 3)
  • Number of Participants Who Quit Smoking at 2 Months(Month 2)
  • Number of People Who Quit Smoking at 4 Months(Month 4)
  • Number of People Who Quit Smoking at 5 Months(Month 5)
  • Number of People Who Quit Smoking at 6 Months(Month 6)
  • Wisconsin Predicting Patient's Relapse Questionnaire(Month 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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