A Randomized Controlled Trial of Smoking Cessation Treatment for Young Adult Dual Users of Combustible and Electronic Cigarettes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 396
- 试验地点
- 1
- 主要终点
- Biochemically Confirmed 7-day Point-prevalence Cigarette Abstinence
研究概览
简要总结
The overarching aim of this proposed randomized controlled trial (RCT) is to test nicotine replacement therapy (NRT) with text message support for two smoking cessation approaches among young adult dual users of combustible cigarettes (CC) and electronic cigarettes (EC). The investigators will use a 2x2 factorial design to randomize 390 participants to receive A) NRT plus text messages to quit CCs only, B) NRT plus text messages to quit CCs and ECs simultaneously, C) text messages alone to quit CCs only, or D) text messages alone to quit CCs and ECs simultaneously. The investigators primary outcome will be 7-day point-prevalence abstinence at the end of treatment (i.e., 3 months after randomization). The investigators will recruit participants using national advertising strategies. All treatment will be provided remotely in order to increase treatment access and comply with current COVID-19 restrictions.
详细描述
The overarching aim of this proposed randomized controlled trial (RCT) is to test nicotine replacement therapy (NRT) with text message support for two smoking cessation approaches among young adult dual users of ombustible cigarettes (CC) and electronic cigarettes (EC). The investigators will use a 2x2 factorial design (Table 1) to randomize 390 participants to receive A) NRT plus text messages to quit CCs only, B) NRT plus text messages to quit CCs and ECs simultaneously, C) text messages alone to quit CCs only, or D) text messages alone to quit CCs and ECs simultaneously. The investigators' primary outcome will be 7-day point-prevalence abstinence at the end of treatment (i.e., 3 months after randomization). All treatment will be provided remotely in order to increase treatment access and comply with COVID-19 restrictions. The proposed RCT addresses the following specific aims:
Aim 1: To test whether NRT is an effective smoking cessation treatment for young adult dual users of ECs and CCs.
Aim 2: To identify the influence of continued EC use versus stopping ECs on achieving CC abstinence among young adult dual users of ECs and CCs.
Aim 3: To identify whether continued EC use results in more acute adverse events than stopping ECs among young adult dual users who are quitting CCs.
The investigators will recruit and consent 390 participants with the aim of retaining 312 (80%) by the end of treatment. Participants in each condition will complete a survey at baseline, weekly surveys throughout the 3-month treatment period, brief daily surveys for one week before and one week after the assigned quit date, an end of treatment survey, and a survey at a follow-up 6 months after treatment began. In addition, participants will provide breath CO samples at baseline, all weekly surveys, the end of treatment, and the 6-month follow-up using the CoVita iCO personal smokerlyzer (https://www.covita.net/ico-overview/).
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
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Quit cigarettes, but continue using e-cigarettes, with nicotine replacement therapy and text support
Participants in this arm will be instructed to quit tobacco cigarettes with nicotine replacement therapy (patches and lozenges) and text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
干预措施: Nicotine replacement therapy patch (Drug)
Quit cigarettes, but continue using e-cigarettes, with nicotine replacement therapy and text support
Participants in this arm will be instructed to quit tobacco cigarettes with nicotine replacement therapy (patches and lozenges) and text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
干预措施: Nicotine replacement therapy lozenge (Drug)
Quit cigarettes, but continue using e-cigarettes, with nicotine replacement therapy and text support
Participants in this arm will be instructed to quit tobacco cigarettes with nicotine replacement therapy (patches and lozenges) and text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
干预措施: Continue electronic cigarettes (Behavioral)
Quit cigarettes and quit e-cigarettes with nicotine replacement therapy and text support.
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with nicotine replacement therapy (patches and lozenges) and text message support.
干预措施: Nicotine replacement therapy patch (Drug)
Quit cigarettes and quit e-cigarettes with nicotine replacement therapy and text support.
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with nicotine replacement therapy (patches and lozenges) and text message support.
干预措施: Nicotine replacement therapy lozenge (Drug)
Quit cigarettes and quit e-cigarettes with nicotine replacement therapy and text support.
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with nicotine replacement therapy (patches and lozenges) and text message support.
干预措施: Quit electronic cigarettes (Behavioral)
Quit cigarettes, but continue using e-cigarettes, with text support.
Participants in this arm will be instructed to quit tobacco cigarettes with text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
干预措施: Continue electronic cigarettes (Behavioral)
Quit cigarettes and quit e-cigarettes with text support.
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with text message support.
干预措施: Quit electronic cigarettes (Behavioral)
结局指标
主要结局
Biochemically Confirmed 7-day Point-prevalence Cigarette Abstinence
时间窗: End of treatment (ie., the 3 month follow up)
The investigators will report breath carbon monoxide (CO; \<6 ppm) confirmed 7-day point-prevalence abstinence from combustible cigarettes at the end of treatment.
Self-reported 7-day Point-prevalence Cigarette Abstinence
时间窗: End of treatment (ie., the 3 month follow up)
The investigators will report self-reported 7-day point-prevalence abstinence from combustible cigarettes at the end of treatment.
Adverse Events During Treatment
时间窗: The 3 month treatment period.
Total number of participants who reported any adverse event during the 3-month treatment period.
次要结局
- Biochemically Confirmed Prolonged 30-day Abstinence(The 3-month follow up (ie., end of treatment))
- Any Attempts to Quit Combustible Cigarettes(The 3-month treatment period.)
- Self-reported Prolonged 30-day Abstinence(The 3-month follow up (ie., end of treatment) and 6-month follow up (3 months after the end of treatment).)
- Cigarettes Per Day(The 3-month treatment period.)
- Cigarette Dependence(The 3-month treatment period.)
研究者
Elias Klemperer
Assistant Professor
University of Vermont