Smoking CessationNCT06586034
Mobile Smoking Treatment for Hispanic Individuals Who Smoke
A study testing Impacto (Mobile App) in people with Smoking Cessation, run by University of Houston.
Trial summary
The specific aims of the project are to develop and test a mobile application for smoking cessation for Hispanic individuals who smoke called Impacto. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Impacto (Mobile App)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 1) being Hispanic, 2) at least 18 years of age, 2) currently smoking (i.e., at least 5 cigarettes/day) biochemically verified by a CO \> 7, 3), meeting criteria for high AS (cut-off score of 5 on the Short Scale Anxiety Sensitivity Index), 4) motivation to quit \> 5 on a 10 pt. scale, 5) able to provide informed consent, 6) has daily access to their own iPhone or Android smartphone, and 7) is a fluent English or Spanish speaker.
Who cannot join
- 1) current participation in substance abuse treatment, 2) in psychotherapy for anxiety or depression, 3) concurrent use of medication for anxiety or depression, 4) active suicidality (ideation, intent, and/or plan), or 5) current psychosis.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Culturally-Adapted Smoking Cessation Mobile App for Hispanic Individuals Who Smoke
The specific aims of the project are to develop and test a mobile application for smoking cessation for Hispanic individuals who smoke called Impacto.
Read the detailed description
A total of 56 Hispanic individuals who smoke will be recruited for this project. Six (6) participants will complete usability/functionality testing of Impacto 2.0 in the English language for both iOS and Android. Following usability/functionality testing, a field test with 50 adult Hispanic individuals who smoke (50% English-speaking and 50% Spanish-speaking) will be recruited nationally and will receive Impacto 2.0 (50% Android and iOS platforms).
- Conditions
- Smoking Cessation
- Being tested
- Impacto (Mobile App)
- Keywords
- Mobile App, Smoking Cessation, Hispanic/Latino
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impacto (Mobile App)Behavioural
This is the mobile app to be developed and evaluated in this project. It is designed for both English and Spanish languages and is culturally tailored for Hispanic/Latino/Latinx individuals who smoke. Impacto will be developed for both iOS and Android platforms. The mobile app aims to aid smoking cessation by targeting elevated anxiety sensitivity.
| Study group | Role | What they receive |
|---|---|---|
| Impacto | Experimental | This is the mobile application to be developed and evaluated in this project. Receives: Behavioral: Impacto (Mobile App) |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-Day Point Prevalence Smoking Abstinence
7-day point prevalence smoking status (verification via carbon monoxide).
Measured: End of treatment (Week 8)
Secondary outcomes (1)
Anxiety Sensitivity
Anxiety sensitivity will be assessed using the Short Scale Anxiety Sensitivity Index (SSASI).
Measured: Baseline, week 4, and end of treatment (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startApr 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Zvolensky, Ph.D., University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586034
- Sponsor's protocol ID
- STUDY00004990
- Status last verified
- Sep 2024
- First submitted
- 3 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally-Adapted Smoking Cessation Mobile App for Hispanic Individuals Who Smoke
- ClinicalTrials.gov ID
- NCT06586034
- Acronym / sponsor ID
- STUDY00004990
- Conditions
- Smoking Cessation
- Keywords
- Mobile App, Smoking Cessation, Hispanic/Latino
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
The specific aims of the project are to develop and test a mobile application for smoking cessation for Hispanic individuals who smoke called Impacto.
Detailed description
A total of 56 Hispanic individuals who smoke will be recruited for this project. Six (6) participants will complete usability/functionality testing of Impacto 2.0 in the English language for both iOS and Android. Following usability/functionality testing, a field test with 50 adult Hispanic individuals who smoke (50% English-speaking and 50% Spanish-speaking) will be recruited nationally and will receive Impacto 2.0 (50% Android and iOS platforms).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Impacto | Experimental | Behavioral: Impacto (Mobile App)This is the mobile application to be developed and evaluated in this project. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) being Hispanic, 2) at least 18 years of age, 2) currently smoking (i.e., at least 5 cigarettes/day) biochemically verified by a CO \> 7, 3), meeting criteria for high AS (cut-off score of 5 on the Short Scale Anxiety Sensitivity Index), 4) motivation to quit \> 5 on a 10 pt. scale, 5) able to provide informed consent, 6) has daily access to their own iPhone or Android smartphone, and 7) is a fluent English or Spanish speaker.
Key exclusion criteria (1 listed)
- 1) current participation in substance abuse treatment, 2) in psychotherapy for anxiety or depression, 3) concurrent use of medication for anxiety or depression, 4) active suicidality (ideation, intent, and/or plan), or 5) current psychosis.
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 (Mobile App)This is the mobile app to be developed and evaluated in this project. It is designed for both English and Spanish languages and is culturally tailored for Hispanic/Latino/Latinx individuals who smoke. Impacto will be developed for both iOS and Android platforms. The mobile app aims to aid smoking cessation by targeting elevated anxiety sensitivity. | Behavioural | Impacto |
Primary outcome
7-Day Point Prevalence Smoking Abstinence
Time frame: End of treatment (Week 8)
7-day point prevalence smoking status (verification via carbon monoxide).
1 secondary outcome
Anxiety Sensitivity
Time frame: Baseline, week 4, and end of treatment (Week 8)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Impacto (Mobile App) in people with Smoking Cessation, run by University of Houston.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justin M Shepherd, PhD (713-743-8056, jmsheph4@central.uh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-Day Point Prevalence Smoking Abstinence (time frame: End of treatment (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 19 Sep 2024.