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

Phase 3

Recruiting

• Conditions: Nicotine Dependence
• Interventions: Behavioral: Aerobic Exercise; Behavioral: Counseling; Drug: Nicotine patch

• Registration Number: NCT06053567
• Lead Sponsor: Jasper A. Smits

Brief 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?

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-09-07
• Study First Submitted QC: 2023-09-13
• Study First Posted: 2023-09-25
• Study Start: 2023-12-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Primary Completion: 2027-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-Intensity Aerobic Exercise	Aerobic Exercise	Participants assigned to this arm will be instructed to complete 75 minutes per week of aerobic training at 60-85% of the their heart rate reserve.
High-Intensity Aerobic Exercise	Counseling	Participants assigned to this arm will be instructed to complete 75 minutes per week of aerobic training at 60-85% of the their heart rate reserve.
High-Intensity Aerobic Exercise	Nicotine patch	Participants assigned to this arm will be instructed to complete 75 minutes per week of aerobic training at 60-85% of the their heart rate reserve.
Low-Intensity Aerobic Exercise	Aerobic Exercise	Participants assigned to this arm will be instructed to complete 75 minutes per week of aerobic training at 20-40% of the their heart rate reserve.
Low-Intensity Aerobic Exercise	Counseling	Participants assigned to this arm will be instructed to complete 75 minutes per week of aerobic training at 20-40% of the their heart rate reserve.
Low-Intensity Aerobic Exercise	Nicotine patch	Participants assigned to this arm will be instructed to complete 75 minutes per week of aerobic training at 20-40% of the their heart rate reserve.

Primary Outcome Measures

Name	Time	Method
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)	Self-report of no smoking (not even a puff) during the previous 7 days, verified by expired carbon monoxide (CO; ≤5ppm), saliva cotinine (\<30 ng/mL), or significant other, and not invalidated by any of these verification measures. Failure to provide any of these 3 verification measures will result in PPA being considered missing.

Secondary Outcome Measures

Name	Time	Method
7-day point prevalence abstinence (PPA) at 12-month follow-up	Protocol week 54, which is 48 weeks (12 months) after the quit attempt (set at week 6)	Self-report of no smoking (not even a puff) during the previous 7 days, verified by expired carbon monoxide (CO; ≤5ppm), saliva cotinine (\<30 ng/mL), or significant other, and not invalidated by any of these verification measures. Failure to provide any of these 3 verification measures will result in PPA being considered missing.
7-day point prevalence abstinence (PPA) at 9-month follow-up	Protocol week 42, which is 36 weeks (9 months) after the quit attempt (set at week 6)	Self-report of no smoking (not even a puff) during the previous 7 days, verified by expired carbon monoxide (CO; ≤5ppm), saliva cotinine (\<30 ng/mL), or significant other, and not invalidated by any of these verification measures. Failure to provide any of these 3 verification measures will result in PPA being considered missing.

Trial Locations

Locations (1)

University of Texas at Austin; 🇺🇸 Austin, Texas, United States