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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Vaping Teens, Vaping Behaviors, Vaping Cessation, Tobacco Use Disorder
- 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 group | Role | What they receive |
|---|---|---|
| Single Arm | Other | See 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.
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
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).
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
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
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)
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
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
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
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
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
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
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.
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.
- First posted25 Sep 2025
- Study start1 May 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Vaping TeensStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- James and Esther King Biomedical Research Program
- Responsible party
- Principal investigator, Elisa M. Trucco, PhD, Florida International University
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 32839050Tackett 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 33167676Valencia 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 35044467Pinedo 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 31531756Lopez-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 16809587Cokkinides 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 18407007Unger 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 34678711Bastiaens 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 28523431Benowitz 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 19019851Bold 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 34753093Cavallo 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 18058412Cristello 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 32559666Dowd 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 29546379Hartmann 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an E-Cigarette Cessation Intervention for Hispanic/Latina(o) Youth in Florida
- ClinicalTrials.gov ID
- NCT07192601
- Acronym / sponsor ID
- IRB-24-0113
- Conditions
- Vaping Teens, Vaping Behaviors, Vaping Cessation, Tobacco Use Disorder
- Keywords
- adolescents, vaping cessation, cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- James and Esther King Biomedical Research Program
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Behavioral: E-cigarette Cessation ManualSee Intervention Section |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-cigarette Cessation ManualThe 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. | Behavioural | Single Arm |
Primary outcome
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
This measure assesses the timing, brand, flavoring, quantity, and frequency of current and past e-cigarette use.
Salivary cotinine samples
Time frame: 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).
To biochemically verify self-reports of abstinence, saliva samples will be obtained using NicAlert cotinine test strips.
Patient-Reported Outcomes Measurement Information System Nicotine Dependence Bank for E-Cigarettes
Time frame: 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
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.
Questionnaire of Vaping Craving
Time frame: 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
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.
Wisconsin Smoking Nicotine Withdrawal Scale
Time frame: 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
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.
8 secondary outcomes
Timeline Followback questionnaire
Time frame: 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
Adolescent E-Cigarette Consequences Questionnaire
Time frame: Baseline assessment: data will be reported on past 1-week expectancies Follow-up assessment: data will be reported on past 1-week expectancies
PROMIS Emotional Distress Depression and Anxiety Pediatric Item Bank
Time frame: 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
Parental Monitoring, Child Disclosure, and Relationship Quality
Time frame: Baseline assessment: data will be reported on past 1-week perceptions Follow-up assessment: data will be reported on past 1-week perceptions
Resistance to Peer Influence
Time frame: Baseline assessment: data will be reported on past 1-week perceptions Follow-up assessment: data will be reported on past 1-week perceptions
Multidimensional Scale of Perceived Social Support
Time frame: Baseline assessment: data will be reported on past 1-week perceptions Follow-up assessment: data will be reported on past 1-week perceptions
Treatment Acceptability
Time frame: Final weekly intervention session: data will be reported on past 2-month general impressions with the treatment.
Treatment Follow-Up Survey
Time frame: 3-month post last session of treatment: data will be reported on past 3-month symptoms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- BackgroundMiech, 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/
- Background: PubMed 32839050Pinedo 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.
- Background: PubMed 33167676Tackett 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.
- Background: PubMed 35044467Valencia 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.
- Background: PubMed 31531756Pinedo 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.
- Background: PubMed 16809587Lopez-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.
- Background: PubMed 18407007Cokkinides 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.
- Background: PubMed 34678711Unger 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.
- Background: PubMed 28523431Bastiaens 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.
- Background: PubMed 19019851Benowitz 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.
- Background: PubMed 34753093Bold 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.
- Background: PubMed 18058412Cavallo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.