Nicotine DependenceNCT03080090
YMCA Exercise Intervention for Smoking Cessation Study
A study testing Aerobic exercise and Smoking Cessation Intervention in people with Nicotine Dependence, run by Jasper A. Smits at 1 site in United States.
Trial summary
Cigarette smoking is the leading cause of death and disability in the United States. Although smoking has declined since 1964, it is still very common among some groups of people. One such group is persons with emotional symptoms and disorders. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Aerobic exercise and Smoking Cessation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2017to 6 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female participants ages 18-65
- Willing and able to provide informed consent, attend all study visits and comply with the protocol
- Daily smoker for at least one year
- Currently smoke an average of at least 5 cigarettes per day
- Report a motivation to quit smoking in the next month of at least 5 on a 10-point scale.
- Anxiety Sensitivity Index-3 score ≥ 23 (cut-off score to identify high AS individuals)
- Sedentary as defined by moderate-intensity exercise less than 3 days/wk for at least 20 minutes each time
- Medical clearance to participate in the protocol
Who cannot join
- Use of other tobacco products (including e-cigarettes)
- A lifetime history of bipolar disorder, schizophrenia, psychosis, or delusional disorders; an eating disorder in the past 6 months; organic brain syndrome, mental retardation or other cognitive dysfunction that could interfere with capacity to engage in therapy; a history of substance or alcohol abuse or dependence (other than nicotine) in the last 6 months or otherwise unable to commit to refraining from alcohol use during the acute period of study participation.
- Patients with significant suicidal ideation as determined by structured interview or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
- Body mass index 40. We selected a BMI of 39.9 as the upper limit in order to screen out individuals with Class III obesity who might be more prone to musculoskeletal injuries than individuals with a BMI<40.0).
- Current use of any psychotherapy for smoking cessation not provided by the researchers.
- Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers during the quit attempt, including Chantix, Zyban, and Nicotine Replacement Treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Cigarette smoking is the leading cause of death and disability in the United States. Although smoking has declined since 1964, it is still very common among some groups of people. One such group is persons with emotional symptoms and disorders. There has been little success in developing treatments for smoking cessation for smokers with affective disturbances.
Recent work suggests that being sensitive to, and less tolerant of, stress is associated with many problems in daily life. People with high 'stress sensitivity' tend to use avoidant strategies to cope with their stress, like smoking. Also, people with high levels of stress sensitivity report stronger beliefs that smoking will reduce negative feelings. They also report having a harder time quitting and in fact, are less successful at doing so. This information suggests that stress sensitivity is important to target during smoking cessation treatment for smokers with affective vulnerabilities.
This clinical trial will evaluate a treatment that integrates exercise to reduce stress sensitivity among high stress sensitive smokers. It builds directly from our recent work and we now seek to adapt it to a more a more accessible and sustainable application. Results will provide important information on the benefit of an integrated intervention that could be used in the community for smokers at great risk for relapse and who do not benefit from existing alternative treatments. This study is the first to test an intervention for stress sensitive smokers and has the potential to help at-risk individuals experience quitting success and, ultimately, reduce the burden of tobacco-related cancers in Texas.
Read the detailed description
Experimental Group. Participants will select a YMCA branch and be assigned a personal fitness instructor who will act as their case manager, overseeing the integrated exercise-based intervention for smoking cessation. Guided by our pilot data showing efficacy and tolerability of the exercise dose, the exercise intervention consists of 75 minutes/week of aerobic training at vigorous-intensity for 15 weeks2. As in the previous study, the aerobic training component will be completed on a treadmill and target training intensity will be self-selected at 60% to 85% of age-predicted heart rate reserve (i.e., vigorous intensity) 2. In order to maximize adherence, the days of the week and training progression schedule will be individualized for each participant based on initial fitness level, travel, and any other issues.
The participant and fitness instructor will meet for three sessions during the first week of exercise training. During the first session, the fitness instructor will describe the program (i.e., treatment model and aims), set a target quit attempt for week 6, develop an exercise training schedule, and supervise the first exercise session to ensure the participant is exercising properly. After two more supervised exercise sessions during the first week, the pair will meet one day per week during the following 14 weeks of the study. The fitness instructors will be responsible for monitoring sessions weekly, problem-solving any difficulties, adjusting the aerobic and/or resistance training regimen as appropriate, and entering the participants exercise data into the (REDCap) database specifically designed for the study.
At the beginning of week 3, the fitness instructor will connect the participant with the quitline (i.e., warm transfer). The Tobacco quitlines are now available in every U.S. state via a national quitline portal, 1-800-QUIT-NOW, and have become the major vehicle through which smoking cessation services are delivered in the U.S.73. All participants will receive the standard telephone counseling package of up to 5 proactive calls from the Texas Tobacco Quitline (https://www.quitnow.net/texas/); we will use a 'warm transfer' (i.e., call the quitline in the presence of the smoker and put them on the phone for the intake interview). Call 1 is an assessment and planning call, Call 2 is a pre-quit date call, Call 3 is a quit date call, and Calls 4 and 5 are maintenance calls if the smoker has quit or problem solving calls if they have not quit. Overall, the counseling protocol aims to (1) provide cognitive-behavioral smoking cessation and relapse prevention tools, tailored to the individual smoker's characteristics and; (2) provide medication management and advice regarding nicotine patch use and adherence support, with the goal of completing a full course of medication - in this case, 8 weeks of transdermal nicotine patch use.
On the target quit day, the fitness instructor will provide the participants with Nicoderm CQ®, 24-hour transdermal nicotine patches (TNP) as part of the study. We chose to provide the patch for 8 weeks because longer than 8 weeks does not appear to improve treatment efficacy10. We chose the TNP because of the extensive empirical literature supporting its effectiveness and safety, its ease of use, and its relatively benign side effect profile that have led to its approval as an over-the-counter medication74. Quitline staff provide instructions on dose and tapering schedule in a fashion consistent with that used in previous trials with a similar formulation of the patch10.
Control Group. The intervention procedures for this group are identical to the Experimental Group group except that the target training intensity will be self-selected at 20% to 40% of age-predicted heart rate reserve (i.e., light intensity).
- Conditions
- Nicotine Dependence
- Being tested
- Aerobic exercise, Smoking Cessation Intervention
- 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
Individuals will work with a YMCA personal trainer to engage in aerobic exercise 3 times a week (25 mins each) for 15 weeks.
Smoking Cessation InterventionBehavioural
Individuals will work with a national quitline to help them with their smoking cessation goals and make a quit attempt at week 5 of the program.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Exercise | Experimental | Individuals in this condition will engage in aerobic exercise 3 times a week for 25 minutes each at 60% to 85% of age-predicted HRmax and smoking cessation intervention through a national quitline while using nicotine replacement patches. Receives: Behavioral: Aerobic exercise; Behavioral: Smoking Cessation Intervention |
| Low Intensity Exercise | Active comparator | The intervention procedures for this group are identical to the Experimental Group group except that the target training intensity will be low intensity exercise, self-selected at 20% to 40% of age-predicted HRmax. Receives: Behavioral: Aerobic exercise; Behavioral: Smoking Cessation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Status after Quit Attempt
Change from baseline in point prevalence abstinence (PPA) after quit attempt at week 6 of the protocol.
Measured: 6 weeks
Smoking Status 1 Month after Quit Attempt
Change from baseline in point prevalence abstinence (PPA) after quit attempt at week 10 of the protocol.
Measured: Week 10
Smoking Status 2 Months after Quit Attempt
Change from baseline in point prevalence abstinence (PPA) after quit attempt at week 14 of the protocol.
Measured: Week 14
Smoking Status 3 Months after Quit Attempt
Change from baseline in point prevalence abstinence (PPA) after quit attempt at week 18 of the protocol.
Measured: Week 18
Smoking Status 6 Months after Quit Attempt
Change from baseline in point prevalence abstinence (PPA) after quit attempt at week 30 of the protocol.
Measured: Week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start12 Apr 2017
- Primary completion6 Jul 2020
- Study completion6 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jasper A. Smits
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas, YMCA
- Responsible party
- Sponsor-investigator, Jasper A. Smits, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080090
- Sponsor's protocol ID
- 2016-12-0049
- Status last verified
- Sep 2020
- First submitted
- 24 Feb 2017
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smits JAJ, Rinck M, Rosenfield D, Beevers CG, Brown RA, Conroy Busch HE, Dutcher CD, Perrone A, Zvolensky MJ, Garey L. Approach bias retraining to augment smoking cessation: A pilot randomized controlled trial. Drug Alcohol Depend. 2022 Sep 1;238:109579. doi: 10.1016/j.drugalcdep.2022.109579. Epub 2022 Jul 25.
PubMed 35917763Smits JAJ, Zvolensky MJ, Rosenfield D, Brown RA, Otto MW, Dutcher CD, Papini S, Freeman SZ, DiVita A, Perrone A, Garey L. Community-based smoking cessation treatment for adults with high anxiety sensitivity: a randomized clinical trial. Addiction. 2021 Nov;116(11):3188-3197. doi: 10.1111/add.15586. Epub 2021 Jun 13.
PubMed 34033178
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- YMCA Exercise Intervention for Smoking Cessation Study
- ClinicalTrials.gov ID
- NCT03080090
- Acronym / sponsor ID
- 2016-12-0049
- Conditions
- Nicotine Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Jasper A. SmitsUniversity, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas, YMCA
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 6 Jul 2020 (actual)
- Study completion
- 6 Jul 2020 (actual)
- First posted
- 15 Mar 2017 (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.
Cigarette smoking is the leading cause of death and disability in the United States. Although smoking has declined since 1964, it is still very common among some groups of people. One such group is persons with emotional symptoms and disorders. There has been little success in developing treatments for smoking cessation for smokers with affective disturbances.
Recent work suggests that being sensitive to, and less tolerant of, stress is associated with many problems in daily life. People with high 'stress sensitivity' tend to use avoidant strategies to cope with their stress, like smoking. Also, people with high levels of stress sensitivity report stronger beliefs that smoking will reduce negative feelings. They also report having a harder time quitting and in fact, are less successful at doing so. This information suggests that stress sensitivity is important to target during smoking cessation treatment for smokers with affective vulnerabilities.
This clinical trial will evaluate a treatment that integrates exercise to reduce stress sensitivity among high stress sensitive smokers. It builds directly from our recent work and we now seek to adapt it to a more a more accessible and sustainable application. Results will provide important information on the benefit of an integrated intervention that could be used in the community for smokers at great risk for relapse and who do not benefit from existing alternative treatments. This study is the first to test an intervention for stress sensitive smokers and has the potential to help at-risk individuals experience quitting success and, ultimately, reduce the burden of tobacco-related cancers in Texas.
Detailed description
Experimental Group. Participants will select a YMCA branch and be assigned a personal fitness instructor who will act as their case manager, overseeing the integrated exercise-based intervention for smoking cessation. Guided by our pilot data showing efficacy and tolerability of the exercise dose, the exercise intervention consists of 75 minutes/week of aerobic training at vigorous-intensity for 15 weeks2. As in the previous study, the aerobic training component will be completed on a treadmill and target training intensity will be self-selected at 60% to 85% of age-predicted heart rate reserve (i.e., vigorous intensity) 2. In order to maximize adherence, the days of the week and training progression schedule will be individualized for each participant based on initial fitness level, travel, and any other issues.
The participant and fitness instructor will meet for three sessions during the first week of exercise training. During the first session, the fitness instructor will describe the program (i.e., treatment model and aims), set a target quit attempt for week 6, develop an exercise training schedule, and supervise the first exercise session to ensure the participant is exercising properly. After two more supervised exercise sessions during the first week, the pair will meet one day per week during the following 14 weeks of the study. The fitness instructors will be responsible for monitoring sessions weekly, problem-solving any difficulties, adjusting the aerobic and/or resistance training regimen as appropriate, and entering the participants exercise data into the (REDCap) database specifically designed for the study.
At the beginning of week 3, the fitness instructor will connect the participant with the quitline (i.e., warm transfer). The Tobacco quitlines are now available in every U.S. state via a national quitline portal, 1-800-QUIT-NOW, and have become the major vehicle through which smoking cessation services are delivered in the U.S.73. All participants will receive the standard telephone counseling package of up to 5 proactive calls from the Texas Tobacco Quitline (https://www.quitnow.net/texas/); we will use a 'warm transfer' (i.e., call the quitline in the presence of the smoker and put them on the phone for the intake interview). Call 1 is an assessment and planning call, Call 2 is a pre-quit date call, Call 3 is a quit date call, and Calls 4 and 5 are maintenance calls if the smoker has quit or problem solving calls if they have not quit. Overall, the counseling protocol aims to (1) provide cognitive-behavioral smoking cessation and relapse prevention tools, tailored to the individual smoker's characteristics and; (2) provide medication management and advice regarding nicotine patch use and adherence support, with the goal of completing a full course of medication - in this case, 8 weeks of transdermal nicotine patch use.
On the target quit day, the fitness instructor will provide the participants with Nicoderm CQ®, 24-hour transdermal nicotine patches (TNP) as part of the study. We chose to provide the patch for 8 weeks because longer than 8 weeks does not appear to improve treatment efficacy10. We chose the TNP because of the extensive empirical literature supporting its effectiveness and safety, its ease of use, and its relatively benign side effect profile that have led to its approval as an over-the-counter medication74. Quitline staff provide instructions on dose and tapering schedule in a fashion consistent with that used in previous trials with a similar formulation of the patch10.
Control Group. The intervention procedures for this group are identical to the Experimental Group group except that the target training intensity will be self-selected at 20% to 40% of age-predicted heart rate reserve (i.e., light intensity).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Exercise | Experimental | Behavioral: Aerobic exercise, Behavioral: Smoking Cessation InterventionIndividuals in this condition will engage in aerobic exercise 3 times a week for 25 minutes each at 60% to 85% of age-predicted HRmax and smoking cessation intervention through a national quitline while using nicotine replacement patches. |
| Low Intensity Exercise | Active comparator | Behavioral: Aerobic exercise, Behavioral: Smoking Cessation InterventionThe intervention procedures for this group are identical to the Experimental Group group except that the target training intensity will be low intensity exercise, self-selected at 20% to 40% of age-predicted HRmax. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female participants ages 18-65
- Willing and able to provide informed consent, attend all study visits and comply with the protocol
- Daily smoker for at least one year
- Currently smoke an average of at least 5 cigarettes per day
- Report a motivation to quit smoking in the next month of at least 5 on a 10-point scale.
Key exclusion criteria (6 listed)
- Use of other tobacco products (including e-cigarettes)
- A lifetime history of bipolar disorder, schizophrenia, psychosis, or delusional disorders; an eating disorder in the past 6 months; organic brain syndrome, mental retardation or other cognitive dysfunction that could interfere with capacity to engage in therapy; a history of substance or alcohol abuse or dependence (other than nicotine) in the last 6 months or otherwise unable to commit to refraining from alcohol use during the acute period of study participation.
- Patients with significant suicidal ideation as determined by structured interview or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
- Body mass index 40. We selected a BMI of 39.9 as the upper limit in order to screen out individuals with Class III obesity who might be more prone to musculoskeletal injuries than individuals with a BMI<40.0).
- Current use of any psychotherapy for smoking cessation not provided by the researchers.
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 exerciseIndividuals will work with a YMCA personal trainer to engage in aerobic exercise 3 times a week (25 mins each) for 15 weeks. | Behavioural | High Intensity Exercise, Low Intensity Exercise |
| Smoking Cessation InterventionIndividuals will work with a national quitline to help them with their smoking cessation goals and make a quit attempt at week 5 of the program. | Behavioural | High Intensity Exercise, Low Intensity Exercise |
Primary outcome
Smoking Status after Quit Attempt
Time frame: 6 weeks
Change from baseline in point prevalence abstinence (PPA) after quit attempt at week 6 of the protocol.
Smoking Status 1 Month after Quit Attempt
Time frame: Week 10
Change from baseline in point prevalence abstinence (PPA) after quit attempt at week 10 of the protocol.
Smoking Status 2 Months after Quit Attempt
Time frame: Week 14
Change from baseline in point prevalence abstinence (PPA) after quit attempt at week 14 of the protocol.
Smoking Status 3 Months after Quit Attempt
Time frame: Week 18
Change from baseline in point prevalence abstinence (PPA) after quit attempt at week 18 of the protocol.
Smoking Status 6 Months after Quit Attempt
Time frame: Week 30
Change from baseline in point prevalence abstinence (PPA) after quit attempt at week 30 of the protocol.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Derived from this study: PubMed 35917763Smits JAJ, Rinck M, Rosenfield D, Beevers CG, Brown RA, Conroy Busch HE, Dutcher CD, Perrone A, Zvolensky MJ, Garey L. Approach bias retraining to augment smoking cessation: A pilot randomized controlled trial. Drug Alcohol Depend. 2022 Sep 1;238:109579. doi: 10.1016/j.drugalcdep.2022.109579. Epub 2022 Jul 25.
- Derived from this study: PubMed 34033178Smits JAJ, Zvolensky MJ, Rosenfield D, Brown RA, Otto MW, Dutcher CD, Papini S, Freeman SZ, DiVita A, Perrone A, Garey L. Community-based smoking cessation treatment for adults with high anxiety sensitivity: a randomized clinical trial. Addiction. 2021 Nov;116(11):3188-3197. doi: 10.1111/add.15586. Epub 2021 Jun 13.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise and Smoking Cessation Intervention 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 8 inclusion and 6 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: finished, as of the sponsor's last update on 15 Jun 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Status after Quit Attempt (time frame: 6 weeks). The study lists 5 primary outcomes in all. 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 NCT03080090, which also lists 2 linked publications.
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 Jun 2026.