360 Participants Needed

Smoking Cessation Program for Smoking

(STEP3 Trial)

MI
ST
Overseen BySydney Thureen, BS
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Jasper A. Smits
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a personalized smoking cessation program that combines aerobic exercise and counseling. It aims to determine if adapting the program for high anxiety-sensitive smokers at the YMCA helps people quit smoking, particularly in racially and ethnically diverse groups. Participants will engage in either low-intensity or high-intensity aerobic exercise each week. Those who smoke daily, have smoked for at least a year, and have high sensitivity to anxiety might be a good fit for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both low and high-intensity aerobic exercises are generally safe for people trying to quit smoking. Studies have found that high-intensity exercise, defined as working out at 60-85% of maximum heart rate, is usually well-tolerated. This type of exercise can help reduce cigarette cravings and support quitting efforts.

Previous research suggests that moderate to vigorous exercise is linked to better quitting success, even for those with high anxiety sensitivity. No major reports of negative effects have emerged from using these exercises to aid smoking cessation.

In summary, past research has demonstrated that both types of aerobic exercise in this study are safe and well-tolerated.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about using aerobic exercise and counseling as a smoking cessation program because it offers a non-pharmaceutical approach to quitting smoking. Unlike traditional treatments that often rely on nicotine replacement therapies or medications like varenicline, this program focuses on physical activity, which can help manage withdrawal symptoms and reduce stress. The trial compares low-intensity and high-intensity aerobic exercise, giving insights into whether the intensity of exercise can further enhance the quitting process. This approach could provide a more holistic and accessible option for individuals looking to quit smoking without medication.

What evidence suggests that this trial's treatments could be effective for smoking cessation?

Research has shown that intense aerobic exercise, which participants in this trial may receive, can help reduce cravings and withdrawal symptoms in smokers. One study found that this type of exercise also lowered anxiety sensitivity, which can lead to smoking relapse. However, whether exercise alone is sufficient to help people quit smoking remains unclear. Some studies have found no significant difference when comparing exercise to other methods. Exercise might be more effective when combined with other strategies, such as counseling, which is included in the Aerobic Exercise and Counseling treatment arm of this trial.26789

Who Is on the Research Team?

JS

Jasper Smits, PhD

Principal Investigator

University of Texas at Austin

Are You a Good Fit for This Trial?

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.
See 2 more

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: High-Intensity Aerobic ExerciseExperimental Treatment3 Interventions
Group II: Low-Intensity Aerobic ExerciseActive Control3 Interventions

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

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

Find a Clinic Near You

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+

Published Research Related to This Trial

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.
Adverse events among high-risk participants in a home-based walking study: a descriptive study.Goodrich, DE., Larkin, AR., Lowery, JC., et al.[2022]
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.
Intermittent exercise in response to cigarette cravings in the context of an Internet-based smoking cessation program.Linke, SE., Rutledge, T., Myers, MG.[2023]
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.
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]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37819741/
Randomized Controlled Trial of Aerobic Exercise for Smoking ...Conclusions: The AE program was not superior to HEC in facilitating smoking cessation, increases in physical activity, or improved depressive ...
Effect of exercise intervention on smoking cessationConclusion: Acute exercise interventions effectively reduce cravings and withdrawal symptoms in smokers. However, long-term exercise ...
Efficacy and implementation of exercise-based smoking ...High-intensity exercise reduces AS as well as tobacco withdrawal and craving ... This study is designed to investigate whether smoking cessation intervention ...
YMCA Exercise Intervention for Smoking Cessation StudyThis clinical trial will evaluate a treatment that integrates exercise to reduce stress sensitivity among high stress sensitive smokers. It builds directly from ...
Effect of exercise type on smoking cessation: a meta-analysis ...There was no effect of aerobic exercise, resisted exercise, physical activity and combined aerobic and resisted exercise on smoking cessation.
Exercise interventions for smoking cessation - PubMed CentralHigh‐intensity interval training and continuous aerobic exercise interventions to promote self‐initiated quit attempts in young adults who smoke ...
Smoking cessation and exercise: perspectives from ...Previous studies have also shown that moderate-intensity exercise led to greater reductions in cigarette cravings than low-intensity exercise (98). In addition ...
The Efficacy of Vigorous-Intensity Exercise as an Aid to ...The present results suggest that exercise faciliates the odds of quit success for smokers with high levels of anxiety sensitivity.
Community-based physical activity as adjunctive smoking ...Moderate-to vigorous-intensity physical activity or exercise is associated with several proximal outcomes that predict quitting success, including acute relief ...
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