After decades of declining smoking rates, young people are returning to tobacco by vaping electronic cigarettes (e-cigarettes). E-cigarettes are currently the most heavily used tobacco product by youth and young adults [1]. According to the 2019 National Youth Tobacco Survey, 27.5% of high school students and 10.5% of middle school students reported using an e-cigarette within the past 30 days [2]. Data from the Centers for Disease Control and Prevention’s National Health Interview Survey showed an increase in e-cigarette use among young adults aged 18 to 24 years, from 5.2% in 2014 to 7.6% in 2018 [3]. Young adults are more likely to use e-cigarettes compared with adults older than 25 years. Recent data also suggest that members of some demographic groups, including men and young adults who identify as Hispanic or as a sexual minority, have a higher prevalence of e-cigarette use than others [4].

E-cigarette use among young adults is associated with future initiation of combustible tobacco use [5,6] and with increased odds of alcohol and marijuana use [7]. However, even if young e-cigarette users do not progress to other products or substances, early exposure to nicotine puts them at risk for a lifetime of addiction as well as largely unknown health risks of long-term e-cigarette use. The majority of e-cigarettes contain nicotine, and the concentrations available in popular products have increased over the past decade [8]. Nicotine has known health effects on brain development occurring into the mid-20s [9]. Specific risks include nicotine addiction, mood disorders, permanent lowering of impulse control, and negative impacts on attention and learning [10]. In addition, the aerosol produced by e-cigarettes contains cancer-causing chemicals and tiny particles that reach deep into the lungs [11].

Many young people want to quit vaping. Across social media platforms, posts, videos, tweets, and comments are ubiquitous from young people about the negative impact that vaping is having on their health and well-being and their desire to quit. Key themes include feeling addicted and unable to control their use of e-cigarettes; deleterious impacts on relationships with family, friends, and significant others; declining academic and athletic performance; concerns about job and career trajectories; and negative health experiences [12].

Unfortunately, the rapid increase of e-cigarette use among young people has left researchers, clinicians, and public health professionals without evidence to turn to about how to effectively support vaping cessation among young people, particularly at the scale necessary. A search for peer-reviewed manuscripts on e-cigarette cessation yields two case reports [13,14], both of which highlight the need for guidelines and research. The 2020 Surgeon General’s Report on Smoking Cessation [15] called for research to develop and understand safe and effective e-cigarette cessation interventions. Although vaping differs from smoking in many important ways, in the absence of scientific literature on vaping cessation, decades of research on best practices for smoking cessation likely provide a useful starting point for intervention design. Smoking cessation treatment delivered via text message has been shown to be effective among young adults [16-18], impacting key psychosocial processes that impact abstinence [19]. Mobile phone ownership is at 99% among young adults [20], and text messaging is an easy-to-use, discreet, anonymous, and preferred communication modality in this age group [21,22], making it a promising modality to reach and engage young people in vaping cessation treatment.

To our knowledge, this protocol describes the first-ever randomized controlled trial to evaluate the effectiveness of a vaping cessation intervention among young adults. The intervention is delivered entirely via text messages and is scalable at a national level. The primary aim of this study is to evaluate the effectiveness of a text message quit vaping program in promoting abstinence from e-cigarettes among young adults aged 18-24 years compared with an assessment-only control condition. Secondary aims are to examine changes in self-efficacy, perceived social norms, and social support for quitting as hypothesized mediators of program effectiveness and to examine if treatment effectiveness is moderated by gender, race/ethnicity, or sexual minority status. The primary hypothesis is that participants in the active intervention arm will be more likely to be abstinent at the 7-month postrandomization primary end point than participants in an assessment-only control arm.

The study is restricted to individuals in the United States. Recruitment, enrollment, and follow-up assessments are conducted via the web, and treatment is delivered via text messages. The study is conducted by Truth Initiative, and the study protocol was approved by the Advarra Institutional Review Board ([IRB] PRO00040067).

This study is a 2-arm randomized controlled trial conducted among 2600 young adult e-cigarette users recruited through web advertisements for a study on vaping cessation. Participants will be randomized to the active text message intervention arm (n=1300) or to an assessment-only control arm (n=1300) in a 1:1 ratio following the methods described below.

Individuals will be eligible if they are aged 18 to 24 years, own a mobile phone and have an active text message plan, are currently using e-cigarettes (defined as past 30-day use), are interested in quitting vaping in the next 30 days, and are a US resident.

Individuals are excluded if they fail to provide contact information during the baseline assessment process (to ensure study retention), if they do not provide informed consent, or if they do not fully enroll in their assigned text message program by responding to the initial system-generated message.

Web advertisements on various platforms (eg, Facebook and Twitter) will describe the study opportunity and lead to the study website, which provides details about study participation, including incentives for participation. Interested individuals will complete eligibility screening followed by informed consent and a baseline assessment. Those who complete the baseline will be randomized into 1 of the 2 arms and instructed to text a specific keyword to the phone number corresponding to their treatment assignment. Only those who respond to an initial opt-in confirmation message from the text message program within 24 hours will be fully enrolled into the study. This requirement will be made explicit.

Following eligibility screening, potential participants must provide informed consent to continue with the enrollment process. The web-based informed consent form provides details about the requirements for study participation, incentive structure, randomization process, plans for protecting human subjects data, and contact information for study staff and Advarra IRB. Agreeing to the informed consent will immediately launch the baseline assessment.

Randomization will occur at the completion of the baseline survey. A computer algorithm embedded in the survey software will automate random allocation in a 1:1 sequence. Investigators will be blind to treatment assignment.

Treatment attrition and loss to follow-up are particular challenges in digital interventions [23], especially among young people [24]. Differential attrition where follow-up rates are higher in one group than in another can bias results [25]. To minimize differential attrition and to optimize overall follow-up assessment completion rates, incentivized text messages asking about e-cigarette use and abstinence will be sent to all participants at 14 days post enrollment and then monthly thereafter through 6 months post randomization. At 14 days, enrollees will be asked, “Checking in: Have you cut down how much you vape nicotine in the past 2 weeks? Respond w/letter: A=I still use the same amount, B=I use less, C=I don’t use at all anymore.” At monthly intervals from 1 month post randomization to 6 months post randomization, enrollees will be asked, “How’s the quit going? When was the last time you vaped nicotine, even a puff of someone else’s? Respond w/ letter: A=in the past 7 days, B=8-30 days ago, C=More than 30 days ago.” Participants in both arms will be compensated US $5 via a digital gift card for each response to these text message assessments (total 7 assessments, possible payment US $35).

The baseline survey will be conducted on the web and hosted on a secure server. Follow-up assessments at 1 month post randomization and 7 months post randomization will be conducted via mixed-mode follow-up. The 7-month postrandomization follow-up is designed to correspond to the 6-month posttreatment follow-up most commonly used in clinical trials and the end point used by quitlines in assessing the effectiveness of a real-world intervention where the end of treatment varies across participants [30]. Participants who do not complete the survey on the web will be contacted by phone and text message by the research staff. Telephone surveys will be conducted by research staff blind to treatment. Text messages will be used as a final means of gathering abstinence data from nonresponders.

There will be no payment for study enrollment or completion of the baseline assessment. Participants will be paid US $20 for completing each follow-up survey via the internet or over the phone with a telephone interviewer, with an additional US $10 incentive for responding within 24 hours of receiving the initial invitation.

This study is the first-ever comparative effectiveness trial of an intervention designed specifically to help young people quit vaping. It is fully powered to examine potentially important subgroup differences among young people who are more vulnerable to e-cigarette use. In addition, it lays the groundwork for future intervention research and begins to build an evidence base for vaping cessation treatment.

Selection of a control condition in a behavioral trial such as this one requires careful consideration and balance between internal and external validity [45]. Masking of treatment assignment can be difficult [46], and developing an inactive behavioral control arm that is credible and equally preferable to participants in the context of a text message intervention is a unique challenge. Participants enrolled in the trial seeking support to quit vaping and expected to receive some form of intervention. Therefore, we elected to use an assessment-only approach for the control arm to deliver an experience that retains subjects while not being so involved that it significantly changes participant behavior.

Conducting a comparative effectiveness trial of a quit vaping program during a time when the e-cigarette product [47-49] and policy [50-52] landscape are in flux is a unique challenge. It is important to acknowledge that myriad contextual factors from the individual level up through the policy level may influence the outcomes of this trial to a greater or lesser degree. We expect that whatever factors are at play and whatever degree of influence they may have, randomization should distribute such influence evenly across both arms.

Several aspects of our trial design and implementation are worth noting as potential limitations. First, the timing of funding availability meant that we launched the study several weeks before the new year. Recruiting during a time when motivation to quit may be higher than at other times during the year may result in somewhat inflated quit rates across the arms. Alternatively, it is possible that the motivation among individuals who attempt to quit vaping around the New Year is more ephemeral and characterized by less dedication and intensity, yielding perhaps lower quit rates than if the study was conducted at a different time of year. Previous research on smoking cessation has supported both possibilities. Regardless, we do not have any reason to believe that this seasonal influence would differentially affect participants in the 2 arms and that this potential confounding factor would be addressed via randomization.

Second, it is important to acknowledge that the active intervention arm is publicly available and being actively promoted through a national education campaign. Participants in both conditions may become aware of this national campaign at some point during the trial. Follow-up measures will assess awareness of the truth campaign and engagement in This is Quitting among control arm participants.

It is also important to note that we have no plans for biochemical verification of abstinence, although this is not necessarily a limitation given the context of this research. Previous digital cessation research has shown low response rates among young people despite a protocol involving minimal participant burden [53]. Indeed, biochemical confirmation is often not practical in large-scale trials with no in-person contact between participants and study staff and where the entirety of the study is conducted digitally [54,55], both of which characterize this trial. Furthermore, biomarkers are more useful for verifying brief periods of smoking abstinence than longer periods of abstinence (eg, our primary end point of 30-day abstinence). We believe that our measurement approach using the methods described by Lantini et al [38] will add important information about the veracity of self-reported cessation outcomes.

Finally, this study focuses on evaluating the effectiveness of the intervention only among young adults aged 18-24 years and does not include teens. Research among teens involves ethical and practical considerations (eg, parental assent) that are not present in research with adults aged 18 years and older. Given that the e-cigarette epidemic is largely concentrated among middle and high school students, it will be important to study this intervention among youth, with the appropriate ethical controls in place.

Research on e-cigarettes, to date, has largely centered on their potential benefit as an alternative to cigarettes and their potential utility as a smoking cessation strategy [15]. While this often-contentious debate continues [56-58], there is an urgent and critical need to identify effective vaping cessation strategies to support the thousands—perhaps hundreds of thousands—of young people who want to quit vaping today. To our knowledge, this study is the first randomized controlled trial that is fully powered to evaluate the effectiveness of an automated, scalable, cost-efficient text message program for vaping cessation designed specifically for young people. Observational data from this program is extremely promising, both in terms of the massive uptake and engagement seen within the first year and also with respect to signals of abstinence. The data generated from this trial will establish a benchmark of effectiveness for other vaping cessation programs and begin to create a body of evidence focused on how best to help young people break free from e-cigarettes.