What this study is
Simplified from ClinicalTrials.govTesting a mobile smoking cessation program (Impacto 2.0) to help people quit smoking and reduce withdrawal and craving, compared with the NCI quitSTART app, in Hispanic adults ages 18 and older who smoke and live in Texas.
Read the original summary from ClinicalTrials.gov
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.
What's being tested
- Impacto 2.0
Intervention · BEHAVIORAL
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.
- quitSTART
Intervention · BEHAVIORAL
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 details
- Official title
- Impacto 2.0: Addressing Disparities in Smoking Cessation Access and Outcomes for Hispanic Adults Who Smoke in Texas
- Sponsor
- Michael J. Zvolensky, Ph.D.
- Conditions
- Cigarette Smoking · Smoking Cessation
- Enrolling
- 100 people
- Starts
- 2027-02-01
- Est. completion
- 2030-12-31
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
- Able to provide informed consent
- Has daily access to an iPhone or Android smartphone
- Fluent in English or Spanish
You can't join if
- 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
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openRESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, Rehabilitation, and Empowerment
Houston, Texas, United States
- Angelica G. Duran, B.S · Contact713-743-8056agduran@cougarnet.uh.edu
- Micheal J Zvolensky, Ph.D. · Principal investigator
Study team
Sponsor
Michael J. Zvolensky, Ph.D.
Study ID STUDY00006201
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.