Young Adult Vaping Cessation: A Randomized Trial Examining Phone Coaching, Text-based Digital Intervention, and Nicotine Replacement Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 508
- 试验地点
- 1
- 主要终点
- 7-day Point Prevalence Vaping Abstinence
研究概览
简要总结
The aim of this study is to test intervention components to help young adults quit vaping. A 2x2 factorial design will be used where all participants receive quitline-delivered behavioral phone counseling, and components to be tested are a digital intervention (with text and online cessation support) and nicotine replacement therapy (NRT).
The research questions and hypotheses for this study are:
- Which components and combinations of intervention yield the greatest success rates for exclusive vaping cessation among young adult exclusive e-cigarette users? H1: The complete condition (NRT + digital) will yield significantly higher rates of cessation compared to the control condition (quitline only).
- Does 8 weeks of nicotine replacement therapy (NRT) improve initial cessation outcomes relative to no NRT.
H2: Providing NRT will yield significantly higher quit rates compared to the No NRT condition. 3. Do tailored text-messages and online support during cessation improve initial cessation outcomes relative to no digital content? Are young adult vapers engaged with and satisfied with digital cessation tools? H3: Digital support will yield significantly higher quit rates compared to no digital support.
H4: Higher engagement in digital content will be associated with higher cessation success rates.
详细描述
The investigators will recruit a national, nonprobability sample of young adults (18-24 year olds) who vape nicotine. All study components will be delivered by phone, mail, online, and mobile device. All participants will receive up to 2 coaching calls and will be randomized to one of four groups: no NRT, no Digital; Digital, no NRT; NRT, no Digital; or NRT and Digital.
Participants (final sample size n = 504) must complete one coaching call to be enrolled in the study. The two coaching calls (approximately 10-20 minutes each) focus on 5 "keys" for quitting: setting a quit date, conquering urges, managing physical withdrawal symptoms (or addressing nicotine replacement needs for the NRT groups), vape-proofing environment, and social supports.
In this real-world trial, coaches will be trained to assess vaping use and dose NRT taking into account use frequency, nicotine level, and participant preference, leveraging quitline standard protocols. Participants may be sent up to 8 weeks (patch, gum, and or lozenge) of product in two shipments. Combination NRT (patch plus gum or lozenge) may be offered.
The digital cessation content includes a text messaging program with links to online education and support materials. The text program will be tailored to a participant's quit stage, and include education, tips, motivational messages, and assessment questions yielding tailored content. The online content (brief videos, audio podcasts, quizzes, etc) can be viewed in small segments via texted links. Participants can also engage with the online content by navigating through lessons or suggested content.
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
- Single (Outcomes Assessor)
盲法说明
Evaluators are blinded to the study arm assignment of participants.
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current, regular user of nicotine e-cigarettes (20+ days in the last month)
- •Exclusive e-cigarette user (no other tobacco in the last 30 days; or no other tobacco in the last 90 days if smoked 100+ cigarettes or cigarillos in lifetime)
- •Interest in quitting in the next 30 days
- •Ownership of a smartphone device
- •Ability to speak and read English
排除标准
- •Pregnant or breastfeeding
- •Individuals with schizophrenia or bipolar disorder who do not report that their condition is currently effectively managed
- •Individuals who have experienced a heart attack or stroke in the two weeks prior, or who have been diagnosed with rapid/irregular heartbeat or angina in the six months prior to taking the eligibility screener
- •Other household members in study
研究组 & 干预措施
DigitalArm
Phone Coaching + Digital Coaching; no NRT: This arm will receive digital content (text messages with links to online materials) in addition to to the two phone counseling calls which all arms will receive.
干预措施: Digital Coaching (Behavioral)
CoachingOnlyArm
Phone Coaching; no Digital Coaching, no NRT: This arm will receive only the two phone counseling calls which all other arms will receive.
干预措施: Phone Counseling (Behavioral)
DigitalArm
Phone Coaching + Digital Coaching; no NRT: This arm will receive digital content (text messages with links to online materials) in addition to to the two phone counseling calls which all arms will receive.
干预措施: Phone Counseling (Behavioral)
CoachingNRTArm
Phone Coaching + NRT; no Digital Coaching: This arm will receive Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
干预措施: Nicotine patch (Drug)
CoachingNRTArm
Phone Coaching + NRT; no Digital Coaching: This arm will receive Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
干预措施: Phone Counseling (Behavioral)
DigitalNRTArm
This arm will receive digital content (text messages with links to online materials) AND Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
干预措施: Nicotine patch (Drug)
DigitalNRTArm
This arm will receive digital content (text messages with links to online materials) AND Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
干预措施: Phone Counseling (Behavioral)
DigitalNRTArm
This arm will receive digital content (text messages with links to online materials) AND Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
干预措施: Digital Coaching (Behavioral)
结局指标
主要结局
7-day Point Prevalence Vaping Abstinence
时间窗: 3 months after the first coaching call (occurred at baseline)
Self-report of no use of e-cigarettes in the past 7 days at the time of the 3-month outcome survey.
次要结局
- Vaping Abstinence(Assessed 3 months after study enrollment)
- E-cigarette Dependence - PROMIS-E(Assessed 3 months after study enrollment)
- E-cigarette Dependence - Penn State E-cigarette Dependence Index(Assessed 3 months after study enrollment)
- Changes in E-cigarette Use Frequency(Assessed at baseline and 3 months after study enrollment)
研究者
Elizabeth G Klein
Professor
Ohio State University