Smoking Cessation Program for Smoking
(STEP3 Trial)
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive counseling and nicotine replacement therapy, and are randomly assigned to either high-intensity or low-intensity aerobic exercise for smoking cessation
Follow-up
Participants are monitored for smoking abstinence and health outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Aerobic Exercise and Counseling
- Nicotine patch
Aerobic Exercise and Counseling is already approved in United States for the following indications:
- Smoking cessation in adults with high anxiety sensitivity
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jasper A. Smits
Lead Sponsor
University of Houston
Collaborator
Oklahoma State University
Collaborator
National Cancer Institute (NCI)
Collaborator
YMCA
Collaborator
University of Oklahoma
Collaborator