An interventional study of Impacto 2.0 and quitSTART in Cigarette Smoking and Smoking Cessation, sponsored by Michael J. Zvolensky, Ph.D.. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Michael J. Zvolensky, Ph.D. · Not applicable, Interventional, and Treatment
This is a preliminary efficacy trial that will examine whether Impacto 2.0 produces higher rates of biochemically verified smoking abstinence among Hispanic adults across Texas compared to the NCI quitSTART app. The primary objective is to evaluate the preliminary efficacy of Impacto 2.0 in reducing smoking, tobacco withdrawal, and craving. One hundred Hispanic adults who smoke will be recruited across Texas and followed remotely over an 8-week intervention period with a 3-month post-quit follow-up.
This project proposes a preliminary efficacy randomized clinical trial (RCT) testing Impacto 2.0, a culturally adapted, bilingual (Spanish and English), smartphone-based smoking cessation intervention developed and pilot tested among Hispanic adults who smoke.
Impacto was originally developed through a National Institutes of Health (NIH)-funded Phase 1 Small Business Technology Transfer (STTR) project using a community-informed, user-centered design process that integrated input from Hispanic end-users, bilingual developers, and clinical providers serving a predominantly Hispanic population. The app targets anxiety sensitivity (AS), or the fear of anxiety-related bodily sensations, which has been empirically shown to be a robust, modifiable transdiagnostic mechanism that impedes smoking cessation success among Hispanic adults.
In a proof-of-concept open trial of Impacto 1.0, 65.4% of Spanish-speaking Hispanic adult participants reported smoking abstinence at 4 weeks post-quit, with significant reductions in anxiety sensitivity and high rates of feasibility, acceptability, and engagement observed across the sample.
The present project aims to extend Impacto 2.0 to Hispanic adults who smoke across Texas, with a statewide targeted recruitment emphasis on rural and medically underserved regions. These regions include communities where geographic, linguistic, and economic barriers may limit access to evidence-based smoking cessation treatment. By leveraging smartphone-based delivery, the study seeks to increase access to culturally adapted smoking cessation support while evaluating the preliminary efficacy of Impacto 2.0 compared to the National Cancer Institute's (NCI) quitSTART app.
475 studies on the registry are indexed under Cigarette Smoking; 86 are open to participants now.
This study's planned enrollment of 100 is close to the median of 96 across 406 interventional studies indexed under Cigarette Smoking.
Browse Cigarette Smoking studies →Michael J. Zvolensky, Ph.D. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will use the Impacto 2.0 smartphone application for 8 weeks.
Behavioral: Impacto 2.0
Participants will use the National Cancer Institute's quitSTART smartphone application for 8 weeks.
Behavioral: quitSTART
A culturally adapted, bilingual smartphone-based smoking cessation intervention that provides psychoeducation targeting anxiety sensitivity reduction. The app includes four lessons per week across the 8-week intervention period and exercises targeting anxiety sensitivity.
The National Cancer Institute's quitSTART smartphone smoking cessation application. The app provides tools to help users understand smoking patterns, track smoking habits and urges, and manage cravings.
Biochemically Verified 7-Day Point Prevalence Smoking Abstinence
Smoking abstinence will be assessed using self-reported 7-day point prevalence abstinence and biochemically verified using the CoVita iCOquit Smokerlyzer. An expired carbon monoxide level \<7 ppm will indicate abstinence.
Time frame: Week 8
Biochemically Verified 7-Day Point Prevalence Smoking Abstinence
Smoking abstinence will be assessed using self-reported 7-day point prevalence abstinence and biochemically verified using the CoVita iCOquit Smokerlyzer. An expired carbon monoxide level \<7 ppm will indicate abstinence.
Time frame: Week 16
Tobacco Withdrawal
Tobacco withdrawal will be assessed using the revised 15-item Minnesota Nicotine Withdrawal Scale (MNWS), a self-report questionnaire measuring smoking withdrawal symptoms. Items are rated on a 5-point Likert scale ranging from 0 (none) to 4 (severe). A withdrawal severity score is calculated by averaging the core withdrawal symptom items, yielding a score ranging from 0 to 4, with higher scores indicating greater tobacco withdrawal severity.
Time frame: Baseline, Week 4, Week 8, and Week 16
Tobacco Craving
Tobacco craving will be assessed using the 10-item Questionnaire of Smoking Urges-Brief (QSU-B), which measures cigarette craving in the current moment. Items are rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). The total score is calculated by summing all 10 items, with possible scores ranging from 10 to 70. Higher scores indicate greater cigarette craving.
Time frame: Baseline, Week 4, Week 8, and Week 16
Anxiety Sensitivity
Anxiety sensitivity will be assessed using the 5-item Short Scale Anxiety Sensitivity Index (SSASI), which measures fear of anxiety-related bodily sensations. Items are rated on a 5-point Likert scale ranging from 0 (very little) to 4 (very much). The total score is calculated by summing all five items, with possible scores ranging from 0 to 20. Higher scores indicate greater anxiety sensitivity.
Time frame: Baseline, Week 4, Week 8, and Week 16
Plan to share: No — There is no plan to make individual participant data (IPD) available to other researchers.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Michael J. Zvolensky, Ph.D.