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Community-based Smoking Cessation Treatment for Adults With High Stress Sensitivity.
NCT06053567 · University of Texas at Austin
In plain English
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Official title
Efficacy and Implementation of Exercise-based Smoking Cessation Treatment for Adults With High Anxiety Sensitivity.
About this study
This protocol provides the recommended treatment to achieve smoking cessation (i.e., counseling and nicotine replacement therapy) and randomly assigns individuals to a high-intensity exercise or low-intensity exercise intervention as a strategy to engage the mechanisms relevant to high anxiety sensitive smokers to improve smoking cessation outcomes.
Eligibility criteria
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
Study design
Enrollment target: 360 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-12-27
Estimated completion: 2028-06-30
Last updated: 2025-04-27
Interventions
Behavioral: Aerobic ExerciseBehavioral: CounselingDrug: Nicotine patch
Primary outcomes
- • 7-day point prevalence abstinence (PPA) at 6-month follow-up (Protocol week 30, which is 24 weeks (6 months) after the quit attempt (set at week 6))
Sponsor
Jasper A. Smits · other
With: University of Houston, University of Oklahoma, National Cancer Institute (NCI), YMCA
Contacts & investigators
ContactMarla I Sarmiento, BS · contact · sarmimar@utexas.edu · 915-502-9979
ContactSydney Thureen, BS · contact · sthureen@utexas.edu · 610-719-7952
InvestigatorJasper Smits, PhD · principal_investigator, University of Texas at Austin
All locations (1)
University of Texas at AustinRecruiting
Austin, Texas, United States