健康免费样品 (FreSH)
2026年6月29日 更新者：Sandra Japuntich
尼古丁替代疗法采样在牙科实践中的有效性
免费健康样品 (FreSH) 研究测试在牙科就诊时提供免费的戒烟药物样品（称为尼古丁替代疗法）是否比提供同等价值的礼物（电动牙刷）能使更多人戒烟。
研究概览
研究类型
介入性
注册 (实际的)
1239
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Minnesota
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Minneapolis、Minnesota、美国、55415
- Hennepin Healthcare Research Institute
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- ≥ 18 岁
- 每个月至少有 25 天每天至少吸 1 支可燃香烟
排除标准：
- 没有可以上网的智能手机
- 过去 3 个月内发生过心肌梗塞或中风
- 怀孕或哺乳
- 过去一周使用戒烟药物
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：电动牙刷
参与者将接受 Ask-Advise-Refer 干预，其中包括口腔健康从业者询问他们的烟草使用情况，建议他们戒烟，并将他们转介给州戒烟热线。
他们还将收到一个样品袋，内含有关吸烟和口腔健康的信息、州戒烟热线和电动牙刷。
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将询问所有患者是否吸烟，建议他们戒烟，并转介州戒烟热线
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实验性的：尼古丁替代疗法
参与者将接受 Ask-Advise-Refer 干预，其中包括口腔健康从业者询问他们的烟草使用情况，建议他们戒烟，并将他们转介给州戒烟热线。
他们还将收到一个样品袋，其中包含有关吸烟和口腔健康的信息、州戒烟热线以及为期两周的 14 毫克尼古丁贴片和 4 毫克含片。
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将询问所有患者是否吸烟，建议他们戒烟，并转介州戒烟热线
14 毫克透皮尼古丁贴剂
4毫克尼古丁锭剂
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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7-day Biochemically Confirmed Point Prevalence Abstinence
大体时间：6 months post baseline
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Percentage reporting no smoking in the 7 days prior to the 6-month follow-up timepoint and having an exhaled carbon monoxide value of less than 6 parts per million
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6 months post baseline
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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7-day Self-reported Point Prevalence Abstinence
大体时间：1 month post baseline
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Proportion reporting no smoking in the 7 days prior to the 1-month follow-up
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1 month post baseline
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7-day Self-reported Point Prevalence Abstinence
大体时间：3 months post baseline
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Proportion reporting no smoking in the 7 days prior to the 3-month follow-up
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3 months post baseline
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24-hour Intentional Quit Attempts
大体时间：6 months post baseline
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proportion reporting a quit attempt of 24 hours or longer in duration over the course of the study
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6 months post baseline
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Smoking Heaviness
大体时间：6 months post baseline
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Change in cigarettes smoked per day from baseline to the 6 month follow-up
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6 months post baseline
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Nicotine Replacement Therapy Utilization
大体时间：6 months post baseline
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Proportion reporting using nicotine patch or nicotine lozenge in the 6 months following baseline
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6 months post baseline
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Perceived Nicotine Replacement Therapy Safety
大体时间：6 months post baseline
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Single item measure of perceived nicotine replacement therapy safety, "Nicotine replacement therapy products (also known as NRT) include the nicotine patch, gum, lozenge, nasal spray, and inhaler.
On a scale of 1 to 5, where 1 is not at all and 5 is very, how concerned are you about the safety of NRT products?"
For this outcome, we report the change from baseline to the 6 month follow-up.
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6 months post baseline
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Perceived Nicotine Replacement Therapy Efficacy
大体时间：6 months post baseline
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Single item measure of perceived nicotine replacement therapy efficacy, "On a scale of 1 to 5, where 1 is not at all, and 5 is very much, how much do you think NRT products improve a smoker's chance of quitting successfully?"
For this outcome, we report the change from baseline to the 6 month follow-up.
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6 months post baseline
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Organizational Readiness for Change
大体时间：From initiation of site enrollment to meeting target recruitment goal or study/site termination (an average of 1 year following site enrollment)
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Rating on a scale of 1 (completely disagree) to 5 (completely agree) on level of agreement with statements regarding the readiness for implementing organizational change (in this case, nicotine replacement therapy sampling).
Scores range from 12-60 with higher scores indicating greater readiness for change.
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From initiation of site enrollment to meeting target recruitment goal or study/site termination (an average of 1 year following site enrollment)
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Acceptability of Intervention Measure
大体时间：From initiation of site enrollment to meeting target recruitment goal or study/site termination (an average of 1 year following site enrollment)
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Rating on a scale of 1 (completely disagree) to 5 (completely agree) on level of agreement with statements regarding the acceptability of the intervention of the study (Nicotine replacement therapy sampling).
Range is 1-5 with higher scores indicating greater acceptability.
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From initiation of site enrollment to meeting target recruitment goal or study/site termination (an average of 1 year following site enrollment)
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Intervention Appropriateness Measure
大体时间：From initiation of site enrollment to meeting target recruitment goal or study/site termination (an average of 1 year following site enrollment)
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Rating on a scale of 1 (completely disagree) to 5 (completely agree) on level of agreement with statements regarding the intervention appropriateness of the study.
cores range from 1-5 with 5 indicating greater appropriateness of nicotine replacement therapy sampling.
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From initiation of site enrollment to meeting target recruitment goal or study/site termination (an average of 1 year following site enrollment)
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Feasibility of Intervention Measure
大体时间：From initiation of site enrollment to meeting target recruitment goal or study/site termination, an average of 1 year following recruitment
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Rating on a scale of 1 (completely disagree) to 5 (completely agree) on level of agreement with statements regarding the feasibility of the intervention of the study.
Scores range from 1-5 with higher scores indicating greater feasibility.
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From initiation of site enrollment to meeting target recruitment goal or study/site termination, an average of 1 year following recruitment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Sandra Japuntich、Hennepin Healthcare/University of Minnesota Medical School
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2023年6月12日
初级完成 (实际的)
2025年6月24日
研究完成 (实际的)
2025年6月24日
研究注册日期
首次提交
2022年11月16日
首先提交符合 QC 标准的
2022年11月16日
首次发布 (实际的)
2022年11月25日
研究记录更新
最后更新发布 (实际的)
2026年7月24日
上次提交的符合 QC 标准的更新
2026年6月29日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.