Treatment of Smoking Lapses and Relapses
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 701
- 试验地点
- 1
- 主要终点
- Point-prevalent Abstinence at 4 Months
研究概览
简要总结
Many smokers who try to stop smoking with nicotine medications (NM) such as gum, lozenge and patch, go back to smoking (i.e., a slip or lapse). Currently, labeling on many NM products tells smokers who lapse while using NM to stop NM. However, some studies suggest it is safe to continue NM upon a lapse and that doing so dramatically increases success at quitting. The investigators will test this by doing a randomized trial in which all treatment and measures are done from home with paper, phone or computer surveys. The investigators will recruit smokers who want to quit, provide them with 10 weeks of nicotine patch treatment and 5 weeks of counseling. One group will be asked to stop use of the patch if they lapse and the other group will be asked to continue use of the patch if they lapse. The investigators will compare the groups on their success at quitting and side-effects.
详细描述
Objectives:
To test our hypothesis that among the subset of the 770 enrolled participants who quit smoking and then lapsed while using the nicotine patch, those randomized to continue the patch post-lapse will be more likely to be 7-day point prevalent abstinent at 4-month follow-up than those randomized to discontinue the patch post-lapse.
To test whether the amount of patch use post-lapse, craving, withdrawal, cigs/day, motivation to quit, confidence in quitting, nicotine reinforcement from cigarettes, and self-efficacy mediate any effect of post-lapse patch use on abstinence.
To test whether the incidence of adverse events (AEs) during post-lapse patch use is minimal.
Purpose:
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
- •at least 18 years old
- •daily smoker of 10 or more cigarettes per day for at least 1 year
- •state they plan to probably or definitely quit smoking in the next month
- •have a home or cell phone
- •willing to use nicotine patch
- •good command of written and spoken English
- •weigh at least 100 pounds
- •US citizen or permanent resident alien
排除标准
- •use of non-cigarette tobacco in the last month
- •use of a smoking cessation medication or smoking cessation counseling in the last month
- •medical contraindication to use of patch
- •other person in household already in our study
- •previously a participant in the study
- •currently pregnant or breast feeding
- •plan to become pregnant in the next 6 months
- •regularly works the overnight shift
- •use of electronic cigarettes in the last month
研究组 & 干预措施
nicotine patch, experimental use
Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.
干预措施: nicotine patch, experimental use (Drug)
nicotine patch, labeled use
Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.
干预措施: nicotine patch, labeled use (Drug)
结局指标
主要结局
Point-prevalent Abstinence at 4 Months
时间窗: 4 months after the quit date
To test our hypothesis that among the subset of the 701 enrolled participants who quit smoking and then lapsed while using the nicotine patch, those randomized to continue the patch post-lapse will be more likely to be 7-day point-prevalent abstinent at 4 month follow-up than those randomized to discontinue the patch post-lapse. 7-day point prevalent abstinence was assessed by response to the question "In the last 7 days, on how many days did you smoke" on the 4 month follow-up survey. Respondents who replied "0" were classified as "Yes" for 7-day point-prevalent abstinence; all other responses (including missing) were classified as "No".
次要结局
- Mediators of Effect of Post-lapse Nicotine Replacement Therapy Use on Abstinence(4 months after the quit date)
- Adverse Drug Effects(Up to 12 weeks)
研究者
John Hughes
Faculty Department of Psychiatry
University of Vermont