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

J

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)

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

Trial contacts and locations

1

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Central trial contact

Marla I Sarmiento, BS; Sydney Thureen, BS

Data sourced from clinicaltrials.gov

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