Recruiting

E-Cigarette Cessation

Sponsor:

Florida International University

Code:

NCT07192601

Conditions

Vaping Teens

Vaping Behaviors

Vaping Cessation

Tobacco Use Disorder

Eligibility Criteria

Sex: All

Age: 14 - 18

Healthy Volunteers: Not accepted

Interventions

E-cigarette Cessation Manual

Study Details

Brief 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. 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.

Conditions

Vaping Teens

Vaping Behaviors

Vaping Cessation

Tobacco Use Disorder

Study ID

NCT07192601

Start date

Oct 26, 2026

Status verified date

Oct, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Study Design

Enrollment

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Single Arm

See Intervention Section

Interventions

E-cigarette Cessation Manual

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.

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 ]
  • 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). ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Elisa Trucco, Ph.D.

305-348-8426etrucco@fiu.edu

Locations

FIU Center for Children and Families

Recruiting

Miami, Florida, United States, 33199

Contacts

Elisa Trucco, Ph.D.

305-348-8426etrucco@fiu.edu

More Information

Sponsor

Florida International University

Last update posted

Oct 28, 2026

Last verified

Oct, 2026

Keywords

  • adolescents
  • vaping cessation
  • cognitive behavioral therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-29. This information was provided to ClinicalTrials.gov by Florida International University on 2026-10-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.