Community-based Smoking Cessation Treatment for Adults With High Stress Sensitivity. (STEP3)

Jasper A. Smits

Status and phase: Enrolling; Phase 3

Conditions: Nicotine Dependence

Treatments: Behavioral: Counseling; Drug: Nicotine patch; Behavioral: Aerobic Exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06053567

R01CA273221 (U.S. NIH Grant/Contract)

2016120049

Details and patient eligibility

About

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?

Full 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

High-Intensity Aerobic Exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Aerobic Exercise

Drug: Nicotine patch

Behavioral: Counseling

Low-Intensity Aerobic Exercise

Active Comparator group

Description:

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.

Treatment:

Behavioral: Aerobic Exercise

Drug: Nicotine patch

Behavioral: Counseling