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临床试验/NCT00851357
NCT00851357已完成3 期

The Efficacy of Telephone Counseling and the Centralized Distribution of Nicotine Replacement Therapy Through a Smoking Cessation Quitline

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 4,200 人开始时间: 2009年2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
4,200
试验地点
1
主要终点
Number of Participants With Six-month Continuous Abstinence From Cigarettes

研究概览

简要总结

The primary purpose of this study is to determine the effects of distributing free nicotine replacement therapy (NRT) to tobacco quitline callers directly. Specifically, this study aims to:

  1. Test if sending active nicotine patches directly will lead to a higher quit rate, compared to a condition where the quitline assists the smokers to obtain patches by other means (e.g. via their health plans).
  2. Test if sending placebo patches directly will also lead to a higher quit rate.
  3. Test if quitline counseling increases the quit rate when the smokers already receive the nicotine patches.

详细描述

Studies have shown that statewide tobacco quitlines can dramatically increase call volume by offering direct mailings of free nicotine replacement therapy (NRT) products. Sending free NRT such as patches to quitline callers, however, often requires a large budget because quitlines have a large number of smokers calling for help each year. A strong rationale is needed for state funding agencies to pay for the patches, which are generally considered the responsibility of health plans. This study will contrast the condition of sending nicotine patches directly from the quitline with a condition where the quitline assists smokers to obtain patches by other means, primarily through their health plans. The study aims to demonstrate that sending patches immediately after smokers call the quitline has a motivational effect that will lead to a higher quit rate than if smokers have to obtain the patches themselves, even if they are able to obtain them for free. To tease apart how much of the effect of sending patches directly from the quitline is due to the active ingredient in the patches and how much is due to motivational effects, this study adds a placebo condition. We hypothesize that the active patches condition will outperform the placebo condition, and the sending of placebo patches will outperform the condition in which the smokers obtain the nicotine patches themselves. We also hypothesize that counseling has its own effect on quitting above and beyond that of the nicotine patches. This study will supply data that can be used to decide what role nicotine replacement therapy should play in publicly funded tobacco cessation programs. Results will also add to the theoretical understanding of behavior change from which new, effective interventions can spring.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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
  • Daily smoker
  • >=6 cigarettes per day
  • Ready to quit within one month
  • First time quitline caller
  • Valid phone number
  • Valid address (no P.O. boxes)
  • California resident
  • Agree to participate in study and evaluation
  • English or Spanish speaking

排除标准

  • Uses other form of tobacco
  • Use of Zyban or Chantix
  • One of the following conditions: Severe allergy to adhesive tape, Arrhythmia, Angina, Heart attack within last year, Stroke within last year, Uncontrolled high blood pressure, Insulin-dependent diabetes, Pregnancy

研究组 & 干预措施

Active patches and telephone counseling

Experimental

Proactive Telephone Counseling and 8-weeks of nicotine patches

干预措施: Nicotine Patch (Drug)

Active patches and materials

Active Comparator

8-weeks of nicotine patches and materials

干预措施: Self-Help Materials (Other)

Active patches and telephone counseling

Experimental

Proactive Telephone Counseling and 8-weeks of nicotine patches

干预措施: Telephone Counseling (Behavioral)

Placebo patches and telephone counseling

Placebo Comparator

Proactive Telephone Counseling and 8-weeks of placebo patches

干预措施: Telephone Counseling (Behavioral)

Placebo patches and telephone counseling

Placebo Comparator

Proactive Telephone Counseling and 8-weeks of placebo patches

干预措施: Placebo (Drug)

Telephone counseling

Active Comparator

Proactive Telephone Counseling

干预措施: Telephone Counseling (Behavioral)

Active patches and materials

Active Comparator

8-weeks of nicotine patches and materials

干预措施: Nicotine Patch (Drug)

Placebo patches and materials

Active Comparator

8-weeks placebo patches and materials

干预措施: Placebo (Drug)

Placebo patches and materials

Active Comparator

8-weeks placebo patches and materials

干预措施: Self-Help Materials (Other)

Materials

Active Comparator

Self-help materials

干预措施: Self-Help Materials (Other)

结局指标

主要结局

Number of Participants With Six-month Continuous Abstinence From Cigarettes

时间窗: 7 months post enrollment

次要结局

  • Number of Participants Quit for 30-days at 2-months Post Enrollment(2-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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