Cigarette SmokingNCT07915973
Impacto 2.0: Mobile Smoking Cessation Across Texas
A study testing Impacto 2.0 and quitSTART in people with Cigarette Smoking and Smoking Cessation, run by Michael J. Zvolensky, Ph.D. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cigarette Smoking, Smoking Cessation
- What is being tested?
- Impacto 2.0 and quitSTART
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2027to 31 Dec 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identifies as Hispanic/Latino/a
- Currently resides in Texas
- Age 18 years or older
- Currently smokes combustible cigarettes daily, biochemically verified by expired carbon monoxide >7 ppm using the CoVita iCOquit Smokerlyzer
- Meets criteria for elevated anxiety sensitivity (cut-off score of 5 on the Short Scale Anxiety Sensitivity Index)
- Motivated to quit smoking
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- Able to provide informed consent
- Has daily access to an iPhone or Android smartphone
- Fluent in English or Spanish
Who cannot join
- Current use of vaping/e-cigarettes, cigars, cigarillos, pipes, cannabis products, or other nicotine/tobacco products in addition to combustible cigarettes
- Current participation in alcohol or drug-use treatment, including smoking-cessation treatment
- Current psychotherapy for anxiety or depression
- Concurrent use of medication for anxiety or depression
- Active suicidality (ideation, intent, and/or plan)
- Current psychosis
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- Currently pregnant, nursing, or actively trying to conceive, including male participants who report that they or a partner are actively trying to conceive
- Myocardial infarction within the past 2 weeks
- Uncontrolled high blood pressure
- Participants with the ability to become pregnant must provide a negative urine pregnancy test before final eligibility/onboarding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, Rehabilitation, and Empowerment
Houston, Texas, 77204
Angelica G. Duran, B.S, 713-743-8056, agduran@cougarnet.uh.edu
Micheal J Zvolensky, Ph.D.
About this study
Official title: Impacto 2.0: Addressing Disparities in Smoking Cessation Access and Outcomes for Hispanic Adults Who Smoke in Texas
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.
Read the detailed description
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.
- Conditions
- Cigarette Smoking, Smoking Cessation
- Being tested
- Impacto 2.0, quitSTART
- Keywords
- Smoking cessation, Hispanic/Latino adults, Anxiety sensitivity, Digital intervention
- Medical subject headings
- Cigarette Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impacto 2.0Behavioural
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.
quitSTARTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Impacto 2.0 | Experimental | Participants will use the Impacto 2.0 smartphone application for 8 weeks. Receives: Behavioral: Impacto 2.0 |
| quitSTART | Active comparator | Participants will use the National Cancer Institute's quitSTART smartphone application for 8 weeks. Receives: Behavioral: quitSTART |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 8
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 4, Week 8, and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Feb 2027 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael J. Zvolensky, Ph.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael J. Zvolensky, Ph.D., University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915973
- Sponsor's protocol ID
- STUDY00006201
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacto 2.0: Addressing Disparities in Smoking Cessation Access and Outcomes for Hispanic Adults Who Smoke in Texas
- ClinicalTrials.gov ID
- NCT07915973
- Acronym / sponsor ID
- STUDY00006201
- Conditions
- Cigarette Smoking, Smoking Cessation
- Keywords
- Smoking cessation, Hispanic/Latino adults, Anxiety sensitivity, Digital intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Michael J. Zvolensky, Ph.D.University, hospital or other
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 4 Nov 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Impacto 2.0 | Experimental | Behavioral: Impacto 2.0Participants will use the Impacto 2.0 smartphone application for 8 weeks. |
| quitSTART | Active comparator | Behavioral: quitSTARTParticipants will use the National Cancer Institute's quitSTART smartphone application for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Self-identifies as Hispanic/Latino/a
- Currently resides in Texas
- Age 18 years or older
- Currently smokes combustible cigarettes daily, biochemically verified by expired carbon monoxide >7 ppm using the CoVita iCOquit Smokerlyzer
- Meets criteria for elevated anxiety sensitivity (cut-off score of 5 on the Short Scale Anxiety Sensitivity Index)
Key exclusion criteria (10 listed)
- Current use of vaping/e-cigarettes, cigars, cigarillos, pipes, cannabis products, or other nicotine/tobacco products in addition to combustible cigarettes
- Current participation in alcohol or drug-use treatment, including smoking-cessation treatment
- Current psychotherapy for anxiety or depression
- Concurrent use of medication for anxiety or depression
- Active suicidality (ideation, intent, and/or plan)
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 |
|---|---|---|
| Impacto 2.0A 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. | Behavioural | Impacto 2.0 |
| quitSTARTThe 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. | Behavioural | quitSTART |
Primary outcome
Biochemically Verified 7-Day Point Prevalence Smoking Abstinence
Time frame: Week 8
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.
4 secondary outcomes
Biochemically Verified 7-Day Point Prevalence Smoking Abstinence
Time frame: Week 16
Tobacco Withdrawal
Time frame: Baseline, Week 4, Week 8, and Week 16
Tobacco Craving
Time frame: Baseline, Week 4, Week 8, and Week 16
Anxiety Sensitivity
Time frame: Baseline, Week 4, Week 8, and Week 16
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 6 Nov 2026.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impacto 2.0 and quitSTART in people with Cigarette Smoking and Smoking Cessation, run by Michael J. Zvolensky, Ph.D. 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 9 inclusion and 10 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: opening soon, as of the sponsor's last update on 6 Nov 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?
Contact Michael J Zvolensky, Ph.D. (713-743-8056, mjzvolen@Central.UH.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically Verified 7-Day Point Prevalence Smoking Abstinence (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2026.