RecruitingPhase 3

Community-based Smoking Cessation Treatment for Adults With High Stress Sensitivity.

United States360 participantsStarted 2023-12-27

Plain-language summary

Anxiety sensitivity, reflecting the fear of bodily sensations, is a risk factor for the maintenance and relapse of smoking. This study is designed to address the question - is a smoking cessation intervention personalized to high anxiety sensitive smokers and adapted for implementation by the YMCA effective among racially/ethnically diverse samples?

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult (age ≥ 18); * High Anxiety Sensitivity (≥5 on the Short Scale Anxiety Sensitivity Index \[SSASI\]); * Daily smoker, ≥5 cigarettes (including e-cigarettes, little cigars/cigarillos) for ≥1 year; * Motivated to quit smoking as evidenced by a score of ≥5 on a 0-10 Likert scale; * Body mass index \< 40; * Medical clearance to participate. * Located near a participating YMCA site (within 50 miles) Exclusion Criteria: * Regular exercise defined as engaging in vigorous-intensity exercise for at least 75 minutes per week for the last 3 months * Receiving current intervention for smoking cessation. * Outstanding debt to the YMCA * Listed as a sex offender on the National Sex Offender Registry

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

7-day point prevalence abstinence (PPA) at 6-month follow-up

Timeframe: Protocol week 30, which is 24 weeks (6 months) after the quit attempt (set at week 6)

Trial details

NCT IDNCT06053567

SponsorJasper A. Smits

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-03-31

Contact for this trial

Marla I Sarmiento, BS

915-502-9979 sarmimar@utexas.edu

View on ClinicalTrials.gov More Nicotine Dependence trials