Efficacy and Implementation of Exercise-based Smoking Cessation Treatment for Adults With High Anxiety Sensitivity.
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 360
- Locations
- 1
- Primary Endpoint
- 7-day point prevalence abstinence (PPA) at 6-month follow-up
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
High-Intensity 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.
Intervention: Aerobic Exercise (Behavioral)
High-Intensity 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.
Intervention: Counseling (Behavioral)
Low-Intensity 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.
Intervention: Aerobic Exercise (Behavioral)
Low-Intensity 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.
Intervention: Counseling (Behavioral)
Low-Intensity 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.
Intervention: Nicotine patch (Drug)
High-Intensity 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.
Intervention: Nicotine patch (Drug)
Outcomes
Primary Outcomes
7-day point prevalence abstinence (PPA) at 6-month follow-up
Time Frame: 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 Outcomes
- 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))
- 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))
Investigators
Jasper A. Smits
Principal Investigator
University of Texas at Austin