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NCT Number: NCT06053567

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

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?

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Key information

Conditions

Nicotine Dependence Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Texas at Austin

Austin, Texas, 78712, United States

Location status: Recruiting

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise

Behavioral

Participants will select a YMCA branch and will be assigned a personal fitness instructor who will oversee a 15-week exercise intervention. The weekly exercise prescription is 75 minutes of aerobic training.

Counseling

Behavioral

Participants will receive the standard tobacco cessation package of up to 5 proactive interactions from the Texas Tobacco Quitline (TTQ). Interactions are typically phone calls, but can be chat or live text if the participant prefers. Interaction 1 is for assessment and quit date planning, Interaction 2 occurs prior to the quit date and can be a group session, Interaction 3 occurs shortly following the quit date, and Interactions 4 and 5 are for relapse prevention if the smoker has quit or problem solving if they have not quit. TTQ also offers a tobacco cessation text messaging program and access to a web portal with a variety of cessation resources.

Nicotine patch

Drug

On the target quit day (week 6), participants will be provided 8 weeks of nicotine replacement therapy (24-hour transdermal nicotine patches [TNP]).

Primary outcomes

  1. 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

  1. 7-day point prevalence abstinence (PPA) at 12-month follow-up

    Time frame: 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.

  2. 7-day point prevalence abstinence (PPA) at 9-month follow-up

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marla I Sarmiento, BS

CONTACT

[email protected]

915-502-9979

Sponsors and collaborators

Lead sponsor

Jasper A. Smits

Other

Collaborators

  • National Cancer Institute (NCI)
  • University of Houston
  • University of Oklahoma
  • YMCA

Registry information

Official study title

Efficacy and Implementation of Exercise-based Smoking Cessation Treatment for Adults With High Anxiety Sensitivity.

Acronym: STEP3

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Sep 25, 2023
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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