Smoking Cessation Program for Smoking

(STEP3 Trial)

Overseen By Sydney Thureen, BS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Jasper A. Smits

Disqualifiers: Regular exercise, Smoking cessation intervention, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

360 Participants Needed

Trial Summary

What is the purpose of this trial?

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?

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Aerobic Exercise and Counseling for smoking cessation?

Research suggests that adding physical exercise to smoking cessation programs may increase the chances of quitting smoking and help manage weight gain. Although some studies show only modest improvements, there is a trend indicating that exercise can enhance the effectiveness of smoking cessation efforts. ^{1 2 3 4 5}

Is the Smoking Cessation Program for Smoking, involving exercise and nicotine patches, generally safe for humans?

Exercise interventions, including high-intensity and supervised programs, are generally safe with rare serious adverse events. Common minor issues like muscle soreness and circulatory problems can occur, but they are not usually serious. Nicotine patches are widely used and considered safe for most people, though they can cause mild side effects like skin irritation. ^{6 7 8 9 10}

How does the Aerobic Exercise and Counseling treatment for smoking cessation differ from other treatments?

This treatment is unique because it combines high-intensity aerobic exercise with counseling to help people quit smoking, potentially reducing cravings and improving mood, which are not typically addressed by standard smoking cessation methods like nicotine replacement therapy. ^{1 2 5 11 12}

Research Team

Jasper Smits, PhD

Principal Investigator

University of Texas at Austin

Eligibility Criteria

This trial is for adults who smoke at least 5 cigarettes daily for over a year, have high anxiety sensitivity, and want to quit smoking. They must be medically cleared to participate and not already exercising regularly or receiving other smoking cessation help.

Inclusion Criteria

Medical clearance to participate

I have been smoking at least 5 cigarettes a day for over a year.

You have a high level of sensitivity to anxiety, as measured by a specific questionnaire.

Exclusion Criteria

You exercise regularly by doing moderate-intensity activities for at least 20 minutes, on at least 3 days every week.

I am currently getting help to stop smoking.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive counseling and nicotine replacement therapy, and are randomly assigned to either high-intensity or low-intensity aerobic exercise for smoking cessation

6 weeks

Weekly visits for exercise sessions

Follow-up

Participants are monitored for smoking abstinence and health outcomes

48 weeks

Periodic follow-up visits at 6, 9, and 12 months

Treatment Details

Interventions

• Aerobic Exercise and Counseling
• Nicotine patch

Trial Overview The study tests if personalized smoking cessation programs that include aerobic exercise, counseling, and nicotine patches are effective for smokers with high stress sensitivity when implemented by the YMCA in diverse communities.

Participant Groups

Group I: High-Intensity Aerobic Exercise Experimental Treatment 3 Interventions

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 II: Low-Intensity Aerobic Exercise Active Control 3 Interventions

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.

Aerobic Exercise and Counseling is already approved in United States for the following indications:

Approved in United States as High-Intensity Aerobic Exercise for:

• Smoking cessation in adults with high anxiety sensitivity

Who Is Running the Clinical Trial?

Jasper A. Smits

Lead Sponsor

Trials

1

Recruited

360+

University of Houston

Collaborator

Trials

155

Recruited

48,600+

Oklahoma State University

Collaborator

Trials

51

Recruited

8,600+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

YMCA

Collaborator

Trials

17

Recruited

2,400+

University of Oklahoma

Collaborator

Trials

484

Recruited

95,900+

Findings from Research

In a pilot study with 38 adult smokers, combining an Internet-based smoking cessation program with intermittent exercise in response to cravings did not significantly improve cessation rates compared to the program alone, indicating that while exercise may be beneficial, it does not guarantee higher success in quitting smoking.

Participants who engaged in more self-reported exercise during the intervention showed a greater reduction in smoking, suggesting that exercise could help manage cravings, but adherence to the exercise regimen remains a challenge that needs further exploration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent exercise in response to cigarette cravings in the context of an Internet-based smoking cessation program. Linke, SE., Rutledge, T., Myers, MG.[2023]

In a study comparing two smoking cessation programs, adding physical exercise to a multicomponent intervention showed a trend towards increased abstinence rates, with 39.4% of participants in the exercise group remaining smoke-free compared to 20.6% in the standard group, although this difference was not statistically significant.

Participants in the exercise group gained significantly more weight if they remained abstinent compared to smokers, suggesting that while exercise may help with quitting smoking, it could also lead to weight gain in those who stop smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does physical exercise in addition to a multicomponent smoking cessation program increase abstinence rate and suppress weight gain? An intervention study. Jonsdottir, D., Jonsdottir, H.[2019]

In a study of 299 smokers undergoing a 7-week cessation program, physical activity counseling did not significantly improve long-term smoking abstinence rates compared to health education advice, with 9.1% abstinence in the exercise group versus 12.4% in the control group at 12 months.

While the exercise group showed increased physical activity levels at six weeks, these benefits did not persist at 12 months, and there was a non-significant trend towards less weight gain in the exercise group, suggesting that more intensive physical activity interventions may be needed for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of physical activity counseling as an aid to smoking cessation: 12 month follow-up. Ussher, M., West, R., McEwen, A., et al.[2007]

In a smoking cessation program involving 40 Greek adults, 18 participants successfully quit smoking for one year, highlighting the program's effectiveness.

Participants also increased their physical activity levels after completing the program, suggesting that integrating physical activity can be a beneficial component of smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial evaluation of a smoking cessation program incorporating physical activity promotion to Greek adults in antismoking clinics. Hassandra, M., Kofou, G., Zourbanos, N., et al.[2015]

In a study involving 330 healthy female smokers, combining cognitive behavioral therapy (CBT) with vigorous exercise did not show significant differences in smoking cessation rates compared to CBT alone, indicating that the exercise component may not have enhanced quitting outcomes.

However, the study found that increased participation in aerobic and resistance training sessions was associated with higher odds of quitting, suggesting that while the overall program didn't differ in effectiveness, more exercise could potentially support smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

YMCA commit to quit: randomized trial outcomes. Whiteley, JA., Williams, DM., Dunsiger, S., et al.[2021]

In a 1.5-year study involving 274 male veterans with cardiovascular disease risk factors, only one serious adverse event (atrial fibrillation) occurred, indicating that a progressive walking program can be safely recommended for high-risk individuals.

While minor musculoskeletal issues were common, over half of the reported adverse events were unrelated to the exercise program, highlighting the need for strategies to help individuals with chronic illnesses safely resume physical activity after any health setbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. Goodrich, DE., Larkin, AR., Lowery, JC., et al.[2022]

The Exercise Harms Reporting Method (ExHaRM) was developed to systematically monitor and report adverse outcomes related to exercise in cancer survivors, addressing a gap in understanding the potential harms of exercise alongside its benefits.

ExHaRM provides a structured protocol for assessing and reporting exercise-related adverse outcomes, which can help clinicians and patients make informed decisions about exercise interventions in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical suggestions for harms reporting in exercise oncology: the Exercise Harms Reporting Method (ExHaRM). Spence, RR., Sandler, CX., Jones, TL., et al.[2023]

A well-rounded aerobic exercise prescription should include optimal frequency, intensity, duration, mode, and progression, tailored to individual medical conditions and exercise tolerance test results.

Incorporating circuit weight training and recreational activities into exercise programs is important for a comprehensive approach, while clinicians must also consider environmental factors and the impact of cardiac medications on exercise responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise prescription guidelines for normal and cardiac populations. Ward, A., Malloy, P., Rippe, J.[2008]

High-intensity exercise interventions significantly improved health outcomes such as cardiovascular fitness (VO2 max), strength, and body composition in cancer survivors, based on a systematic review of nine studies involving 531 participants.

The risk of adverse events during supervised high-intensity exercise was low, making it a safe and effective option for cancer survivors looking to enhance their physical health in a time-efficient manner.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity exercise interventions in cancer survivors: a systematic review exploring the impact on health outcomes. Toohey, K., Pumpa, K., McKune, A., et al.[2022]

In a study of 35,110 exercise interventions for pediatric cancer patients and survivors, serious adverse events (AEs) were rare, with only six Grade 2-3 AEs reported, resulting in an incidence of 17 per 100,000 interventions, indicating that supervised exercise programs are generally safe.

While Grade 1 AEs, such as muscle soreness and circulatory problems, were more common (2,800 per 100,000 interventions), these were typically mild and likely not directly caused by the exercise, suggesting that exercise can be safely integrated into cancer care for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events During Supervised Exercise Interventions in Pediatric Oncology-A Nationwide Survey. Gauß, G., Beller, R., Boos, J., et al.[2021]

Aerobic exercise (AE) significantly reduces anxiety before quitting smoking and decreases both anxiety and craving after quitting, suggesting it can be a helpful tool in smoking cessation efforts.

The mood-enhancing effects of AE were only observed in individuals who maintained smoking abstinence, indicating that exercise may provide additional psychological benefits during the quitting process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Effects of Aerobic Exercise on Affect and Smoking Craving in the Weeks Before and After a Cessation Attempt. Abrantes, AM., Farris, SG., Minami, H., et al.[2022]

In a randomized controlled trial with 61 smokers, a 12-week exercise intervention showed higher verified smoking abstinence rates compared to a health education control, suggesting that exercise may enhance smoking cessation efforts.

Participants who engaged in higher levels of moderate-to-vigorous exercise reported lower depressive symptoms, indicating that exercise could have additional mental health benefits during smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary randomized controlled trial of a behavioral exercise intervention for smoking cessation. Abrantes, AM., Bloom, EL., Strong, DR., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Intermittent exercise in response to cigarette cravings in the context of an Internet-based smoking cessation program. [2023]

2. Sweden pubmed.ncbi.nlm.nih.gov

Does physical exercise in addition to a multicomponent smoking cessation program increase abstinence rate and suppress weight gain? An intervention study. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of physical activity counseling as an aid to smoking cessation: 12 month follow-up. [2007]

4. United States pubmed.ncbi.nlm.nih.gov

Initial evaluation of a smoking cessation program incorporating physical activity promotion to Greek adults in antismoking clinics. [2015]

5. Netherlands pubmed.ncbi.nlm.nih.gov

YMCA commit to quit: randomized trial outcomes. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Practical suggestions for harms reporting in exercise oncology: the Exercise Harms Reporting Method (ExHaRM). [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise prescription guidelines for normal and cardiac populations. [2008]

9. Germany pubmed.ncbi.nlm.nih.gov

High-intensity exercise interventions in cancer survivors: a systematic review exploring the impact on health outcomes. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events During Supervised Exercise Interventions in Pediatric Oncology-A Nationwide Survey. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Acute Effects of Aerobic Exercise on Affect and Smoking Craving in the Weeks Before and After a Cessation Attempt. [2022]

12. England pubmed.ncbi.nlm.nih.gov

A preliminary randomized controlled trial of a behavioral exercise intervention for smoking cessation. [2021]