NICOTINE REPLACEMENT--EFFECTS OF COST & MINIMAL SUPPORT
NICOTINE REPLACEMENT--EFFECTS OF COST & MINIMAL SUPPORT
批准号:
2121699
负责人:
SCOTT J LEISCHOW
金额:
$29.73万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
1994
资助国家:
美国
项目状态:
已结题
起止时间:
1994-09-30 至 1999-07-31
关键词:
clinical trials cognitive behavior therapy combination therapy drug abuse chemotherapy drug administration rate /duration drug screening /evaluation health care cost /financing human subject human therapy evaluation longitudinal human study nicotine oral administration questionnaires self help smoking cessation tobacco abuse transdermal drug delivery
中文摘要
尼古丁替代治疗吸烟依赖已成为一种
流行但有争议的治疗方式有很多方法,
尼古丁可以给药,从而允许更多的选择,
个性化治疗。然而,其中一个争议是,
尼古丁替代是它本身有效还是仅在
行为治疗计划的背景下。此外,还有人担心,
一些使用尼古丁替代品的人会依赖
尼古丁的这种形式。
不幸的是,很少有研究评估的有效性和长期使用的
尼古丁替代治疗的背景下,
行为治疗计划,甚至更少有评估的依赖性
尼古丁替代产品的潜力。拟议的研究是
旨在评估尼古丁贴片和口香糖在
真正的自助计划。没有关于戒烟的建议将
他提供给实验对象。
前两项拟议的研究是随机、双盲、安慰剂-
对照临床试验旨在分别评估(1)
尼古丁口香糖和尼古丁贴片使用时间更长的可能性
(2)不考虑吸烟状况,
尼古丁口香糖和贴片作为自助戒烟的辅助手段
议定书前两项研究的治疗条件如下:
研究1:15 mg尼古丁或安慰剂透皮贴剂,研究2:4 mg,
2 mg或安慰剂咀嚼胶。
后两项研究是随机临床试验,
分别评价(1)尼古丁贴片和口香糖成本对
(2)这些产品将被用于
比推荐的时间更长,以及(3)4 mg的戒断率
尼古丁口香糖和15 mg尼古丁贴片(3 Ocm 2)作为药物的功能
后两项研究的治疗条件如下:研究
#3:15毫克尼古丁贴片全价(5 O美元/盒,14片),半价
(25美元/盒),或免费,和研究#4:4毫克尼古丁口香糖全价
(每盒96件66美元),半价(每盒33美元),或免费。
拟议研究的结果可以使人们更好地了解
尼古丁替代产品的功效,当最小的行为
提供治疗,并且费用不同。结果也可能
有助于作出关于可能转向过度使用的决策,
非处方药状态。
英文摘要
Nicotine replacement for the treatment of smoking dependence has become a
popular yet controversial form of treatment There are many ways in which
nicotine can be administered, thus allowing for more options for
individualized treatment. However, one of the controversies regarding
nicotine replacement is whether it is efficacious by itself or only in the
context of a behavioral treatment program. In addition, there is concern
that some of those who use nicotine replacement will become dependent on
that form of nicotine.
Unfortunately, few studies have assessed the efficacy and long term use of
nicotine replacement treatments in the context of a very minimal
behavioral treatment program, and even fewer have evaluated the dependence
potential of nicotine replacement products. The proposed studies were
designed to assess the safety and efficacy of nicotine patch and gum in a
truly self-help program. No recommendations about smoking cessation will
he provided to subjects.
The first two proposed studies are randomized, double-blind, placebo-
controlled clinical trials designed to separately assess (1) the
likelihood that nicotine gum and patch will be used for longer periods
than recommended (regardless of smoking status) and (2) the efficacy of
nicotine gum and patch as aids to smoking cessation in a self-help
protocol. Treatment conditions in the first two studies are as follows:
Study #1: 15 mg nicotine or placebo transdermal patch, and Study #2: 4 mg,
2 mg, or placebo gum.
The second two studies are randomized clinical trials designed to
separately evaluate (1) the effect of nicotine patch and gum cost on
medication use, (2) the likelihood that these products will be used for
longer periods than recommended, and (3) the abstinence rates of 4 mg
nicotine gum and 15 mg nicotine patch (3Ocm2) as a function of medication
cost Treatment conditions in the second two studies are as follows: Study
# 3:15 mg nicotine patch at full price ($5O/box of 14), half price
($25/box), or at no cost, and Study #4: 4 mg nicotine gum at full price
($66/box of 96 pieces), half price ($33/box), or at no cost.
The results of the proposed studies can lead to a better understanding of
the efficacy of nicotine replacement products when minimal behavioral
treatment is provided and when costs are varied. The results could also
contribute to decision-making regarding the potential switch to over-the-
counter medication status.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
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海外基金