Effectiveness of Nicotine Replacement Therapy Sampling in Dental Practices
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,239
- 试验地点
- 1
- 主要终点
- 7-day biochemically confirmed point prevalence abstinence
研究概览
简要总结
The Free Samples for Health (FreSH) study tests whether providing free samples of stop smoking medicine called nicotine replacement therapy at dental visits results in a greater number of people quitting smoking than providing a gift of equal value (an electric toothbrush).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None (Outcomes Assessor)
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
- •smokes at least 1 combustible cigarette per day on at least 25 days of the month
排除标准
- •does not own a smartphone with internet access
- •myocardial infarction or stroke in the past 3 months
- •pregnant or breastfeeding
- •use of tobacco cessation medication in the past week
研究组 & 干预措施
Nicotine Replacement Therapy
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and a two week supply of 14mg nicotine patches and 4mg lozenges.
干预措施: Nicotine lozenge (Drug)
Electric Toothbrush
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and an electric toothbrush.
干预措施: Ask-Advise-Refer (Behavioral)
Nicotine Replacement Therapy
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and a two week supply of 14mg nicotine patches and 4mg lozenges.
干预措施: Ask-Advise-Refer (Behavioral)
Nicotine Replacement Therapy
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and a two week supply of 14mg nicotine patches and 4mg lozenges.
干预措施: Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release (Drug)
结局指标
主要结局
7-day biochemically confirmed point prevalence abstinence
时间窗: 6 months post baseline
Proportion 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
7-day Biochemically Confirmed Point Prevalence Abstinence
时间窗: 6 months post baseline
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
次要结局
- 7-day self-reported point prevalence abstinence(1 month post baseline)
- 24-hour intentional quit attempts(6 months post baseline)
- Smoking heaviness(6 months post baseline)
- Nicotine replacement therapy utilization(6 months post baseline)
- Perceived nicotine replacement therapy safety(6 months post baseline)
- Perceived nicotine replacement therapy efficacy(6 months post baseline)
- 7-day Self-reported Point Prevalence Abstinence(1 month post baseline)
- 7-day Self-reported Point Prevalence Abstinence(3 months post baseline)
- 24-hour Intentional Quit Attempts(6 months post baseline)
- Smoking Heaviness(6 months post baseline)
- Nicotine Replacement Therapy Utilization(6 months post baseline)
- Perceived Nicotine Replacement Therapy Safety(6 months post baseline)
- Perceived Nicotine Replacement Therapy Efficacy(6 months post baseline)
研究者
Sandra Japuntich
Sandra Japuntich, Ph.D., L.P.
Hennepin Healthcare Research Institute