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

NCT ID: NCT06053567

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-27

Study Completion Date

2028-06-30

Brief Summary

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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

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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.

Conditions

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Nicotine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Aerobic Exercise

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Aerobic Exercise

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

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

Interventions

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Aerobic Exercise

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.

Intervention Type BEHAVIORAL

Counseling

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.

Intervention Type BEHAVIORAL

Nicotine patch

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Houston

OTHER

Sponsor Role collaborator

University of Oklahoma

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

YMCA

OTHER

Sponsor Role collaborator

Jasper A. Smits

OTHER

Sponsor Role lead

Responsible Party

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Jasper A. Smits

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jasper Smits, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

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University of Texas at Austin

Austin, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Marla I Sarmiento, BS

Role: CONTACT

915-502-9979

Sydney Thureen, BS

Role: CONTACT

610-719-7952

Other Identifiers

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R01CA273221

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2016120049

Identifier Type: -

Identifier Source: org_study_id

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