iQuit Smoking: A Randomized Trial of Internet Access to Nicotine Patches
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,485
- 试验地点
- 1
- 主要终点
- Self-reported 6-month Prolonged Abstinence From Smoking
研究概览
简要总结
People who smoke cigarettes have an increased risk of developing emphysema, heart disease, and certain types of cancer. This study will evaluate the effectiveness of providing free nicotine patches from an online smoking cessation program, with and without telephone counseling, at improving quit rates in cigarette smokers.
详细描述
The objective of this project is to determine the efficacy and cost-effectiveness of providing access to free nicotine patches, with or without a required linkage to proactive telephone counseling, as adjuncts to internet-assisted tobacco treatment. Online cessation services will be provided by the Center for Health Communication Research at the University of Michigan.
This investigation has three specific aims and one exploratory aim:
- Specific Aim 1: To determine the efficacy of providing access to free nicotine patches as an addition to online smoking cessation services.
- Specific Aim 2: To determine the efficacy of providing access to free nicotine patches linked with proactive telephone counseling as an addition to online smoking cessation services.
- Specific Aim 3: To determine the cost-effectiveness of providing access to free nicotine patches, with or without linkage to proactive phone counseling, as additions to online cessation services.
- Exploratory Aim 1: To examine potential mediators and moderators of intervention effects. An examination of potential mediators will identify key psychological and behavioral processes (e.g. medication adherence, self-efficacy, etc.) that underlie how the interventions affect the process of quitting and offer guidance regarding key targets for future research. An examination of potential moderators (e.g. level of dependence, income, gender) will identify candidate subgroups for which the proposed interventions may be more effective and cost- effective.
Smokers searching online for help quitting (N=2,475) will be recruited and randomized to receive one of three treatments:
- online smoking cessation services (i.e. web),
- online cessation services plus access to free nicotine patches (i.e.web+patch),
- online cessation services with access to free patches contingent upon participation in proactive telephone counseling (i.e. web+patch+phone).
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
- 是
入选标准
- •Currently smokes 10 or more cigarettes per day
- •Does not use any tobacco products other than cigarettes
- •Willing to set a quit date within 2 to 4 weeks following study entry
- •Willing to use a nicotine patch
- •Able to speak English
- •Access to Internet, email, and telephone at work or home
- •Resident of the United States
- •Only one person per household is eligible to enroll
排除标准
- •Medically unable to use the nicotine patch (e.g., pregnant, history of a heart attack)
- •Currently uses nicotine replacement therapy (NRT) products
- •Currently uses or plans to use Bupropion SR, Wellbutrin, or Zyban
研究组 & 干预措施
NRT Patch, Phone Counseling, Internet
As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.
干预措施: Nicotine patches (Drug)
NRT Patch, Phone Counseling, Internet
As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.
干预措施: Telephone counseling (Behavioral)
NRT Patch, Phone Counseling, Internet
As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.
干预措施: iQuit Smoking website (Behavioral)
Nicotine Patches and Internet
As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.
干预措施: Nicotine patches (Drug)
Nicotine Patches and Internet
As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.
干预措施: iQuit Smoking website (Behavioral)
Internet
Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).
干预措施: iQuit Smoking website (Behavioral)
结局指标
主要结局
Self-reported 6-month Prolonged Abstinence From Smoking
时间窗: Measured at 9 Months post-randomization
Participants complete the final study survey 9 months following enrollment in the program. They are asked to report when they had last smoked a cigarette, even a puff. Participants who report that they have not smoked in the past 6 months are counted as abstinent for the purposes of our study analysis.
次要结局
- Self-reported 30-day Prolonged Abstinence at 3-month Follow up(3-months post randomization)
- Self-reported 30-day Prolonged Abstinence at 9-month Follow up(9 months post randomization)
研究者
Lawrence C. An
Associate Professor of Internal Medicine, Medical School
University of Michigan