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Vaping TeensNCT07192601

Developing an E-Cigarette Cessation Intervention for Hispanic/Latina(o) Youth in Florida: The BReATHE Study

A study testing E-cigarette Cessation Manual in people with Vaping Teens and Vaping Behaviors, run by Florida International University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Electronic (e-)cigarettes are the most used nicotine product among U.S. youth. Hispanic/Latino (H/L) youth are at greater risk for e-cigarette use, yet few evidence-based cessation programs exist for youth, and even fewer are tailored to H/L youth. Read more about this study

Who is it for?
Ages 14 to 18 years
Conditions the study is for
Vaping Teens, Vaping Behaviors, Vaping Cessation
What is being tested?
E-cigarette Cessation Manual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
1 May 2024to 30 Apr 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Enrolled in high school or 14-18 years old
  • Fluent in English
  • Identify as being of Hispanic/Latino origin
  • Report current use of e-cigarettes (i.e., used ≥ 4x in the past month or at least 1x per week in the past month)

Who cannot join

  • Having a history of severe psychiatric conditions (e.g., bipolar disorder, schizophrenia, psychosis, or schizoaffective disorder)
  • Currently enrolled in or planning on enrolling in another e-cigarette and/or tobacco cessation intervention
  • Having potential difficulties comprehending study procedures (e.g., not able to speak/write in English, have a severe learning disability or other neurodevelopmental disorders)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • FIU Center for Children and Families

    Miami, Florida, 33199

Other trials in United States

About this study

Official title: Developing an E-Cigarette Cessation Intervention for Hispanic/Latina(o) Youth in Florida

Electronic (e-)cigarettes are the most used nicotine product among U.S. youth. Hispanic/Latino (H/L) youth are at greater risk for e-cigarette use, yet few evidence-based cessation programs exist for youth, and even fewer are tailored to H/L youth. The current work will develop and pilot an e-cigarette cessation intervention for H/L high school youth, using focus groups with the target population and input from a community advisory board (CAB). The intervention will be tested with 120 H/L high school students who use e-cigarettes to assess its feasibility and promise for reducing use.

Read the detailed description

While e-cigarette use remains alarmingly high among all adolescents (Miech et al., 2023), recent findings suggest that H/L adolescents are even more likely to use e-cigarettes (1.3 times more use compared to White adolescents; Tackett et al., 2020). These risks are compounded by disparities in care and treatment engagement among H/L individuals (Unger et al., 2022; Cokkinides et al., 2008; Lopez-Quintero et al., 2006; Valencia et al., 2022; Pinedo \& Villatoro, 2020; Pinedo et al., 2020). To address this gap, the investigators developed an e-cigarette cessation intervention, called the BReATHE program, specifically for H/L high school students. The program is grounded in an empirically supported psychosocial smoking cessation program (i.e., Cognitive Behavioral Therapy, CBT; Cavallo et al., 2007; Krishnan-Sarin et al., 2013; Vinci et al., 2020) that has been found to be effective in both adults, as well as adolescents. The program consists of six 60-minute in-person group sessions that build participants' knowledge of nicotine and vaping, teach cognitive-behavioral strategies to recognize and cope with triggers and negative emotions, strengthen communication and relaxation skills, and conclude with a graduation activity where youth share what they have learned with their families. Baseline assessment will be conducted individually, either in person or remotely, and will include questionnaires (1 hour). Prior to each weekly intervention session, participants will complete a 5-minute online survey on REDCap reporting their e-cigarette use and use of other substances from the past week. Participants will also be asked to complete a 30-minute follow-up questionnaire session in person or remotely three months after completing the e-cigarette cessation intervention. During the first and last sessions, as well as during the three-month follow-up session, participants will complete a salivary cotinine assessment, administered by a trained research assistant, to objectively quantify nicotine exposure and assess change in use. If it is not feasible to complete the assessment in person, the saliva test may be mailed to the participant and completed remotely.

Being tested
E-cigarette Cessation Manual
Keywords
adolescents, vaping cessation, cognitive behavioral therapy
Medical subject headings
Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E-cigarette Cessation ManualBehavioural

    The intervention is grounded in an empirically supported psychosocial smoking cessation program (i.e., Cognitive Behavior Therapy [CBT]; Vinci, 2020), as well as a manualized CBT e-cigarette intervention for adolescents and young adults (Kong et al., 2017; Kong et al., 2021). The structure and content of the manual were further informed by themes identified through focus groups. The newly developed BReATHE Program will consist of six 60-minute group sessions. "Building Knowledge for Change" focuses on nicotine vaping psychoeducation. "Recognizing the Triangle" introduces the cognitive triangle. "Anticipating Triggers" offers tools to cope with internal and external triggers to vape. "Tranquil Minds" offers relaxation techniques to manage negative emotions. "Healthy Communication" teaches clients more effective ways to communicate. "Educate Others" consists of reviewing skills and planning for the graduation ceremony where youth will teach family members what they learned.

Study groups in NCT07192601
Study groupRoleWhat they receive
Single ArmOtherSee Intervention Section
Receives: Behavioral: E-cigarette Cessation Manual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. E-Cigarette Assessment for Youth-Revised checklist

    This measure assesses the timing, brand, flavoring, quantity, and frequency of current and past e-cigarette use.

    Measured: Baseline assessment: data will be reported on past 1-month and 1-year e-cigarette use Each weekly intervention session: data will be reported on past 1-week e-cigarette use Follow-up assessment: data will be reported on past 1-month e-cigarette use

  2. Salivary cotinine samples

    To biochemically verify self-reports of abstinence, saliva samples will be obtained using NicAlert cotinine test strips.

    Measured: Saliva cotinine samples that can detect past-week nicotine use will be obtained at Baseline (Week 0), at the end of treatment (Week 6), and at the 3-month follow-up after treatment completion (Week 18).

  3. Patient-Reported Outcomes Measurement Information System Nicotine Dependence Bank for E-Cigarettes

    The Patient-Reported Outcomes Measurement Information System Nicotine Dependence Bank for E-Cigarettes (PROMIS-E) is a 4-item measure (each item scored on a 5-point Likert scale) that assesses nicotine dependence. Values range from 0 to 16 with higher scores representing worse outcomes.

    Measured: Baseline assessment: data will be reported on past 1-month symptoms Each weekly intervention session: data will be reported on past 1-week symptoms Follow-up assessment: data will be reported on past 1-month symptoms

  4. Questionnaire of Vaping Craving

    The Questionnaire of Vaping Craving (QVC) is a 10-item measure (each item scored on a 7-point Likert scale) that assesses vaping craving. Values range from 10 to 70 with higher scores representing worse outcomes.

    Measured: Baseline assessment: data will be reported on past 1-month craving Each weekly intervention session: data will be reported on past 1-week craving Follow-up assessment: data will be reported on past 1-month craving

  5. Wisconsin Smoking Nicotine Withdrawal Scale

    The Wisconsin Smoking Nicotine Withdrawal Scale (WSWS) is a 28-item measure (each item scored on a 5-point Likert scale) that assesses nicotine withdrawal symptoms. Values range from 0 to 112 with higher scores representing worse outcomes.

    Measured: Baseline assessment: data will be reported on past 1-week withdrawal symptoms Each weekly intervention session: data will be reported on past 1-week withdrawal symptoms Follow-up assessment: data will be reported on past 1-week withdrawal symptoms

Secondary outcomes (8)
  1. Timeline Followback questionnaire

    Frequency and quantity of current and past use of other substances beyond e-cigarettes (e.g., other tobacco products, alcohol, cannabis) will also be queried.

    Measured: Baseline assessment: data will be reported on past 1-month and past 1-year substance use Each weekly intervention session: data will be reported on past 1-week substance use Follow-up assessment: data will be reported on past 1-month substance use

  2. Adolescent E-Cigarette Consequences Questionnaire

    The Adolescent E-Cigarette Consequences Questionnaire (AECQ) is a 31-item measure (each item scored on a 5-point Likert scale) that assesses outcome expectancies when using an e-cigarette. Values range from 31 to 155 with higher scores representing worse outcomes.

    Measured: Baseline assessment: data will be reported on past 1-week expectancies Follow-up assessment: data will be reported on past 1-week expectancies

  3. PROMIS Emotional Distress Depression and Anxiety Pediatric Item Bank

    This is a 5-item measure (each item scored on a 5-point Likert scale) that assesses symptoms of depression and anxiety. Values range from 0 to 20 with higher scores representing worse outcomes.

    Measured: Baseline assessment: data will be reported on past 2-week symptoms experienced Follow-up assessment: data will be reported on past 2-week symptoms experienced

  4. Parental Monitoring, Child Disclosure, and Relationship Quality

    This 22-item measure (each item scored on a 5-point Likert scale) assesses parental monitoring, child disclosure, and relationship quality. Values range from 0 to 88 with higher scores representing better outcomes.

    Measured: Baseline assessment: data will be reported on past 1-week perceptions Follow-up assessment: data will be reported on past 1-week perceptions

  5. Resistance to Peer Influence

    The Resistance to Peer Influence (RPI) is a 10-item measure (each item scored on a 4-point Likert scale) that assesses an adolescent's ability to resist peer influence across multiple hypothetical scenarios. Values range from 0 to 40 with higher scores representing better outcomes.

    Measured: Baseline assessment: data will be reported on past 1-week perceptions Follow-up assessment: data will be reported on past 1-week perceptions

  6. Multidimensional Scale of Perceived Social Support

    Social support (e.g., friends, family members) will be measured by this 12-item (each item scored on a 7-point Likert scale) measure. Values range from 12 to 84 with higher scores representing better outcomes.

    Measured: Baseline assessment: data will be reported on past 1-week perceptions Follow-up assessment: data will be reported on past 1-week perceptions

  7. Treatment Acceptability

    Participants will complete a survey encompassing multiple-choice questions and open-ended text boxes regarding their satisfaction with the vaping cessation program.

    Measured: Final weekly intervention session: data will be reported on past 2-month general impressions with the treatment.

  8. Treatment Follow-Up Survey

    Participants will complete a survey encompassing multiple-choice questions regarding their age, grade, parental monitoring, peer norms and influence, social support, depression and anxiety symptoms, and substance use.

    Measured: 3-month post last session of treatment: data will be reported on past 3-month symptoms.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2025
  2. Study start1 May 2024
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion30 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
As this is a pilot study, all participants (N=120) will be enrolled in the same vaping cessation program, which will be grounded in an empirically supported psychosocial smoking cessation program (i.e., Cognitive Behavioral Therapy, CBT) that has been found to be effective in both adults, as well as adolescents.
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07192601
Sponsor's protocol ID
IRB-24-0113
Other IDs
24K09
Status last verified
Sep 2026
First submitted
5 Sep 2025
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Miech, R. A., Johnston, L. D., Patrick, M. E., O'Malley, P. M., & Bachman, J. G. (2023). Monitoring the Future national survey results on drug use, 1975-2023: Secondary school students. Monitoring the Future Monograph Series. Ann Arbor, MI: Institute for Social Research, University of Michigan. Available at https://monitoringthefuture.org/results/annual-reports/

  • Pinedo M, Villatoro AP. The role of perceived treatment need in explaining racial/ethnic disparities in the use of substance abuse treatment services. J Subst Abuse Treat. 2020 Nov;118:108105. doi: 10.1016/j.jsat.2020.108105. Epub 2020 Aug 13.

    PubMed 32839050
  • Tackett AP, Keller-Hamilton B, Hebert ET, Smith CE, Wallace SW, Stevens EM, Johnson AL, Wagener TL. Adolescent Susceptibility to E-Cigarettes: An Update From the 2018 National Youth Tobacco Survey. Am J Health Promot. 2021 May;35(4):551-558. doi: 10.1177/0890117120971121. Epub 2020 Nov 10.

    PubMed 33167676
  • Valencia CV, Dove M, Tong EK. Factors Associated With Receipt of Smoking Cessation Advice and Assistance by Health Professionals Among Latino and Non-Latino White Smokers With Medicaid Insurance in California. JAMA Netw Open. 2022 Jan 4;5(1):e2144207. doi: 10.1001/jamanetworkopen.2021.44207.

    PubMed 35044467
  • Pinedo M, Zemore S, Beltran-Giron J, Gilbert P, Castro Y. Women's Barriers to Specialty Substance Abuse Treatment: A Qualitative Exploration of Racial/Ethnic Differences. J Immigr Minor Health. 2020 Aug;22(4):653-660. doi: 10.1007/s10903-019-00933-2.

    PubMed 31531756
  • Lopez-Quintero C, Crum RM, Neumark YD. Racial/ethnic disparities in report of physician-provided smoking cessation advice: analysis of the 2000 National Health Interview Survey. Am J Public Health. 2006 Dec;96(12):2235-9. doi: 10.2105/AJPH.2005.071035. Epub 2006 Jun 29.

    PubMed 16809587
  • Cokkinides VE, Halpern MT, Barbeau EM, Ward E, Thun MJ. Racial and ethnic disparities in smoking-cessation interventions: analysis of the 2005 National Health Interview Survey. Am J Prev Med. 2008 May;34(5):404-12. doi: 10.1016/j.amepre.2008.02.003.

    PubMed 18407007
  • Unger JB, Falcon A. E-cigarette use among Hispanics: Reducing risk or recruiting new tobacco users? Addict Behav. 2022 Feb;125:107149. doi: 10.1016/j.addbeh.2021.107149. Epub 2021 Oct 12.

    PubMed 34678711
  • Bastiaens L, Galus J. The DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure as a Screening Tool. Psychiatr Q. 2018 Mar;89(1):111-115. doi: 10.1007/s11126-017-9518-7.

    PubMed 28523431
  • Benowitz NL, Bernert JT, Caraballo RS, Holiday DB, Wang J. Optimal serum cotinine levels for distinguishing cigarette smokers and nonsmokers within different racial/ethnic groups in the United States between 1999 and 2004. Am J Epidemiol. 2009 Jan 15;169(2):236-48. doi: 10.1093/aje/kwn301. Epub 2008 Nov 19.

    PubMed 19019851
  • Bold K, Kong G, Cavallo D, Davis D, Jackson A, Krishnan-Sarin S. School-based E-cigarette cessation programs: What do youth want? Addict Behav. 2022 Feb;125:107167. doi: 10.1016/j.addbeh.2021.107167. Epub 2021 Oct 28.

    PubMed 34753093
  • Cavallo DA, Cooney JL, Duhig AM, Smith AE, Liss TB, McFetridge AK, Babuscio T, Nich C, Carroll KM, Rounsaville BJ, Krishnan-Sarin S. Combining cognitive behavioral therapy with contingency management for smoking cessation in adolescent smokers: a preliminary comparison of two different CBT formats. Am J Addict. 2007 Nov-Dec;16(6):468-74. doi: 10.1080/10550490701641173.

    PubMed 18058412
  • Cristello JV, Sutherland MT, Trucco EM. A preliminary validation of the adolescent e-cigarette consequences questionnaire. Drug Alcohol Depend. 2020 Aug 1;213:108118. doi: 10.1016/j.drugalcdep.2020.108118. Epub 2020 Jun 12.

    PubMed 32559666
  • Dowd AN, Motschman CA, Tiffany ST. Development and Validation of the Questionnaire of Vaping Craving. Nicotine Tob Res. 2019 Jan 1;21(1):63-70. doi: 10.1093/ntr/nty046.

    PubMed 29546379
  • Hartmann SA, Cristello JV, Manresa O, Trucco EM. The e-cigarette assessment for youth-Revised (EAsY-R): Preliminary results of a pilot study of measure refinement via cognitive interviewing. J Res Adolesc. 2024 Sep;34(3):845-856. doi: 10.1111/jora.12957. Epub 2024 Apr 28.

    PubMed 38679807

Questions about this trial

What is this clinical trial studying?

A study testing E-cigarette Cessation Manual in people with Vaping Teens and Vaping Behaviors, run by Florida International University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

E-Cigarette Assessment for Youth-Revised checklist (time frame: Baseline assessment: data will be reported on past 1-month and 1-year e-cigarette use Each weekly intervention session: data will be reported on past 1-week e-cigarette use Follow-up assessment: data will be reported on past 1-month e-cigarette use). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07192601, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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