Smoking Cessation With the Nicotine Patch: A Pilot Study of Patch Messaging
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 243
- 试验地点
- 1
- 主要终点
- Number of Participants Who Have Not Used Tobacco in the Past 30 Days
研究概览
简要总结
The primary purpose of this study is to test the feasibility of sending pre-cessation nicotine patches and to examine the effects associated with the pre-cessation treatment phase. Specifically, this study aims to:
- See if subjects will use pre-cessation nicotine patches.
- See if subjects in the pre-cessation nicotine patches go on to get more nicotine patches.
- See if pre-cessation treatment with nicotine patches leads to a decrease in number of cigarettes smoked per day.
- See if sending 2-weeks' worth of patches is helpful to the quitting process.
详细描述
Quitlines have become central to state tobacco control efforts in the U.S. In addition to offering telephone counseling, many quitlines have begun providing quitting aids (e.g., nicotine patch) to eligible smokers. The nicotine patch has been shown repeatedly to double the rate of quitting success compared to a placebo control. Recently a number of studies have examined the use of patches prior to quitting. A meta-analysis indicates that such pre-cessation treatment with nicotine patches doubles the odds of quitting, compared to starting patch treatment on the quit day, as is traditionally done.
The proposed study would look at both pre-cessation treatment with nicotine patches as well as looking to see if sending clients nicotine patches is helpful in their quitting process. The rationale for pre-cessation treatment with patches is that using patches in this manner would make it easier to quit smoking because it may: reduce the reinforcing effects of cigarette smoking, thus helping to overcome conditioned behavior; reduce the need for inhaled nicotine as smokers naturally decrease their cigarette consumption to titrate the level of nicotine in their system; and/or increase compliance with patch use in the quitting phase.
The rationale for sending nicotine patches is that when callers must go and get the patches on their own it creates a barrier to their quitting so that sending nicotine patches directly to a callers' home would make it easier for them to stay on task and quit. This pilot will allow us to test the feasibility of sending pre-treatment nicotine patches and to examine the effects associated with the pre-cessation treatment phase.
This pilot project has the following specific aims, to examine whether:
- Subjects will use pre-cessation nicotine patches.
- Subjects in the pre-cessation nicotine patches go on to get more nicotine patches.
- Pre-cessation treatment with nicotine patches leads to a decrease in number of cigarettes smoked per day.
- Sending 2-weeks' worth of patches is helpful to the quitting process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- 否
入选标准
- •>= 18 years old
- •Daily smoker
- •>=10 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 speaking
排除标准
- •Uses other form of tobacco
- •Plan to use quitting aids other than nicotine patch
- •Has any of the following conditions:
- •Severe allergy to adhesive tape
- •Arrhythmia
- •Heart attack within last 6 months
- •Stroke within last 6 months
- •Uncontrolled high blood pressure
- •Insulin-dependent diabetes
- •Pregnancy
研究组 & 干预措施
Pre-Patch and Telephone Counseling
Nicotine patches (2 weeks' worth) are mailed directly to the subject. Clients will be encouraged to start using these patches PRIOR to their quit date.
Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.
干预措施: Telephone Counseling (Behavioral)
Pre-Patch and Telephone Counseling
Nicotine patches (2 weeks' worth) are mailed directly to the subject. Clients will be encouraged to start using these patches PRIOR to their quit date.
Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.
干预措施: Nicotine Patches (Drug)
Post-Patch and Telephone Counseling
Nicotine patches (2 weeks' worth) are mailed directly to the subject. Clients are encouraged to start using their patches ON their quit date.
Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.
干预措施: Telephone Counseling (Behavioral)
Post-Patch and Telephone Counseling
Nicotine patches (2 weeks' worth) are mailed directly to the subject. Clients are encouraged to start using their patches ON their quit date.
Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.
干预措施: Nicotine Patches (Drug)
Telephone Counseling and no patches sent
Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.
干预措施: Telephone Counseling (Behavioral)
结局指标
主要结局
Number of Participants Who Have Not Used Tobacco in the Past 30 Days
时间窗: 2-months post enrollment
At a given point in time (in this case, 2 months after program registration), quitline participants are asked whether they have used cigarettes or other forms of tobacco in the past 30 days. Those who reply that they have not used tobacco in the past 30 days are considered to have quit.
次要结局
- Number of Participants With Serious Quit Attempts(2-months post enrollment)
研究者
Shu-Hong Zhu
Professor
University of California, San Diego