Nicotine DependencePhase 3STEP3NCT06053567

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

A Phase 3 study testing Aerobic Exercise, Counseling and Nicotine patch in people with Nicotine Dependence, run by Jasper A. Smits at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Nicotine Dependence
What is being tested?: Aerobic Exercise, Counseling and Nicotine patch
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 360 participants
Where: 1 siteUnited States
Study dates: 27 Dec 2023to 30 Jun 2029
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

Who cannot join

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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marla I Sarmiento, BS contact

915-502-9979

sarmimar@utexas.edu

United States1 site, 1 recruiting

University of Texas at Austin
Austin, Texas, 78712
Recruiting

Other trials in United States

About this study

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

Read the 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.

Conditions: Nicotine Dependence
Being tested: Aerobic Exercise, Counseling, Nicotine patch
Medical subject headings: Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06053567
Study group	Role	What they receive
High-Intensity Aerobic Exercise	Experimental	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. Receives: Behavioral: Aerobic Exercise; Behavioral: Counseling; Drug: Nicotine patch
Low-Intensity Aerobic Exercise	Active comparator	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. Receives: Behavioral: Aerobic Exercise; Behavioral: Counseling; Drug: Nicotine patch

What is being measured

The primary outcome is the main question the study is designed to answer.

7-day point prevalence abstinence (PPA) at 6-month follow-up
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.
Measured: Protocol week 30, which is 24 weeks (6 months) after the quit attempt (set at week 6)

Secondary outcomes (2)

7-day point prevalence abstinence (PPA) at 12-month follow-up
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.
Measured: 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
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.
Measured: Protocol week 42, which is 36 weeks (9 months) after the quit attempt (set at week 6)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Dec 202330 Jun 2029

First posted25 Sep 2023
Study start27 Dec 2023
Primary completion31 Mar 2029 (estimated)
Study completion30 Jun 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Nicotine DependenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 360 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06053567
Sponsor's protocol ID: 2016120049
Other IDs: R01CA273221
Acronym: STEP3
Status last verified: May 2026
First submitted: 7 Sep 2023
Last updated: 15 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Within one year of completion (publication) of the primary aims for this project, we will provide de-identified data from this project to interested researchers. The data are to be provided in a SPSS file or Excel, with separate documentation of labels/characteristics for each column of data. Data will be released directly by Dr. Smits's team at UT to investigators providing evidence of their institution's IRB approval for planned analyses of the data.

Interested in taking part?

Marla I Sarmiento, BS

915-502-9979

sarmimar@utexas.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
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Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
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The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
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Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product

All Nicotine Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Implementation of Exercise-based Smoking Cessation Treatment for Adults With High Anxiety Sensitivity.
ClinicalTrials.gov ID: NCT06053567
Acronym / sponsor ID: STEP3 / 2016120049
Conditions: Nicotine Dependence
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 360 participants (estimated)
Lead sponsor: Jasper A. SmitsUniversity, hospital or other
Collaborators: University of Houston, University of Oklahoma, National Cancer Institute (NCI), YMCA
Study start: 27 Dec 2023 (actual)
Primary completion: 31 Mar 2029 (estimated)
Study completion: 30 Jun 2029 (estimated)
First posted: 25 Sep 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
High-Intensity Aerobic Exercise	Experimental	Behavioral: Aerobic Exercise, Behavioral: Counseling, Drug: Nicotine patchParticipants 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.
Low-Intensity Aerobic Exercise	Active comparator	Behavioral: Aerobic Exercise, Behavioral: Counseling, Drug: Nicotine patchParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aerobic ExerciseParticipants 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.	Behavioural	High-Intensity Aerobic Exercise, Low-Intensity Aerobic Exercise
CounselingParticipants 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.	Behavioural	High-Intensity Aerobic Exercise, Low-Intensity Aerobic Exercise
Nicotine patchOn the target quit day (week 6), participants will be provided 8 weeks of nicotine replacement therapy (24-hour transdermal nicotine patches [TNP]).	Drug	High-Intensity Aerobic Exercise, Low-Intensity Aerobic Exercise

Primary outcome

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.

2 secondary outcomes

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)
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)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
Individual participant dataSharing planned: Yes. Within one year of completion (publication) of the primary aims for this project, we will provide de-identified data from this project to interested researchers. The data are to be provided in a SPSS file or Excel, with separate documentation of labels/characteristics for each column of data. Data will be released directly by Dr. Smits's team at UT to investigators providing evidence of their institution's IRB approval for planned analyses of the data.

Related trials for Nicotine Dependence

Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Marla I Sarmiento, BS contact

915-502-9979

sarmimar@utexas.edu

Jasper Smits, PhD principal investigator

University of Texas at Austin

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aerobic Exercise, Counseling and Nicotine patch in people with Nicotine Dependence, run by Jasper A. Smits at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marla I Sarmiento, BS (915-502-9979, sarmimar@utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06053567.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.