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临床试验/NCT01736085
NCT01736085已完成3 期

Distribution of Voucher vs. Direct Mailing of Nicotine Patches to Quitline Smokers

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 3,706 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
3,706
试验地点
1
主要终点
Number of Participants With Six Months Prolonged Abstinence

研究概览

简要总结

The California Smokers' Helpline will conduct a 3 X 2 (nicotine patch by counseling condition) randomized trial to test the provision of nicotine patches to help smokers calling a telephone quitline. The study assesses one factor related to nicotine patches with 3 levels: sending patches directly from the Helpline, providing vouchers that can be redeemed for patches, and usual care. A second factor is counseling plus materials versus materials only. This proposed study has the following specific aims:

  1. To demonstrate that a voucher for free nicotine patches will increase the quit rate for smokers who do not have access to free nicotine replacement therapy (NRT)
  2. To demonstrate that sending patches directly from a quitline would outperform sending vouchers for free NRT, since the vouchers impose an additional barrier to those who want to quit
  3. To determine the effect of telephone counseling in the context of nicotine patch distribution and if any interaction effects exist between counseling and patch conditions

详细描述

Tobacco smoking leads to nicotine dependence and serious health consequences. Telephone counseling has been shown to improve smokers' chances of quitting and is the most accessible of the three evidence-based forms of counseling (individual face-to-face, group, and telephone). It is well established that offering free NRT can attract many more smokers to call a quitline. However, how much the offer of free NRT helps quitline callers quit successfully is less well documented. There is currently no consistent guideline for quitline practice. We want to determine whether two weeks' worth of starter kit nicotine patches is efficacious for smokers who don't have access to free nicotine patches or quitting aids. The study also will provide data regarding the impact of a barrier to obtaining quitting aids by contrasting a direct mailing condition with a voucher condition. Further, the study will help us determine the effect of telephone counseling in the context of nicotine patch distribution and if any interaction effects exist between counseling and patch conditions

The study uses a randomized controlled design. Smokers who call the Helpline during the recruitment phase, who meet eligibility requirements for the trial and give consent will be randomly assigned to one of six groups along two factors (nicotine patch and telephone counseling), as described below.

The 6 randomized groups are as follows: Group 1: Materials, Group 2: Voucher + Materials, Group 3: Patches + Materials, Group 4: Counseling, Group 5: Voucher + Counseling, Group 6: Patches + Counseling

Two months and seven months after their initial contact with the Helpline, all participants will receive two Assessment Interviews by phone. The interview will cover, as appropriate, smoking status, use of nicotine patches and other quitting aids, history of quitting, and satisfaction with services provided. The Assessment Interview lasts from 5-10 minutes.

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 or older
  • Current smoker
  • First time quitline caller
  • Not eligible for nicotine patches through other programs such as MediCal or Los Angeles County which provides free nicotine patches
  • English and/or Spanish speaking
  • Valid phone number
  • Valid address
  • CA resident
  • Gave consent to participate in study and evaluation

排除标准

  • Contraindication(s) to nicotine patches
  • Uses a form of tobacco other than cigarettes
  • Plans to use Chantix

研究组 & 干预措施

Materials plus Voucher

Active Comparator

Subjects will receive self-help materials and a voucher for 2 week's worth of nicotine patches

干预措施: Voucher (Behavioral)

Materials plus Patches

Active Comparator

Subjects will receive self-help materials and a 2 week's worth of nicotine patches

干预措施: Nicotine patches (Drug)

Counseling

Active Comparator

Subjects will receive up to 5 sessions of telephone counseling

干预措施: Telephone counseling (Behavioral)

Counseling plus Voucher

Active Comparator

Subjects will receive up to 5 sessions of telephone counseling plus a voucher for 2 week's worth of nicotine patches.

干预措施: Telephone counseling (Behavioral)

Counseling plus Voucher

Active Comparator

Subjects will receive up to 5 sessions of telephone counseling plus a voucher for 2 week's worth of nicotine patches.

干预措施: Voucher (Behavioral)

Counseling plus Patches

Active Comparator

Subjects will receive up to 5 sessions of telephone counseling plus 2 week's worth of nicotine patches.

干预措施: Telephone counseling (Behavioral)

Counseling plus Patches

Active Comparator

Subjects will receive up to 5 sessions of telephone counseling plus 2 week's worth of nicotine patches.

干预措施: Nicotine patches (Drug)

结局指标

主要结局

Number of Participants With Six Months Prolonged Abstinence

时间窗: Seven months post enrollment

At seven months post enrollment we will conduct a brief telephone survey to assess smoking status. The information obtained will allow us to determine six month prolonged abstinence rates.

次要结局

  • Percentage of Smokers Making a 24-hour Quit Attempt(Two months post enrollment)

研究者

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

Shu-Hong Zhu

Professor

University of California, San Diego

研究点 (1)

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