Actively Recruiting

Phase 3
Age: 18Years +
All Genders
Healthy Volunteers
ID06053567

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

Led by Jasper A. Smits · Updated on 2026-05-15

360

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

J

Jasper A. Smits

Lead Sponsor

U

University of Houston

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a smoking cessation intervention tailored for adults with high anxiety sensitivity, which is the fear of bodily sensations that may contribute to continued smoking and relapse. This study aims to determine if a personalized program delivered through the YMCA is effective among racially and ethnically diverse groups. The investigation is a phase 3 randomized trial comparing different exercise intensities alongside standard cessation support to improve quitting success. Participants receive recommended smoking cessation treatments including counseling via the Texas Tobacco Quitline and nicotine replacement therapy with patches starting on the quit day (week 6). They are randomly assigned to either a high-intensity aerobic exercise group, exercising 75 minutes weekly at 60-85% heart rate reserve, or a low-intensity aerobic exercise group with 75 minutes weekly at 20-40% heart rate reserve. The exercise intervention lasts 15 weeks and is supervised by a personal fitness instructor at a YMCA branch. Throughout the study, participants are monitored for smoking abstinence at several time points, with the main outcome being 7-day point prevalence abstinence at 6 months after the quit attempt. Additional follow-ups occur at 9 and 12 months. Researchers track adherence to exercise, counseling interactions, and nicotine patch use. The total study duration includes initial assessments, a quit attempt at week 6, and follow-ups extending to 12 months. Safety and effectiveness are assessed without masking, and participants are from diverse backgrounds motivated to quit smoking.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult (age 218 years or older2)
  • High Anxiety Sensitivity score of 5 or more on the Short Scale Anxiety Sensitivity Index (SSASI)
  • Daily smoker of at least 5 cigarettes (including e-cigarettes or little cigars/cigarillos) for at least 1 year
  • Motivated to quit smoking with a score of 5 or more on a 0-10 scale
  • Body mass index less than 40
  • Medical clearance to participate
  • Located near a participating YMCA site (within 50 miles)
Not Eligible

You will not qualify if you...

  • Regular vigorous-intensity exercise for at least 75 minutes per week over the last 3 months
  • Currently receiving any intervention for smoking cessation
  • Outstanding debt to the YMCA
  • Listed as a sex offender on the National Sex Offender Registry

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 15 weeks

Participants engage in a 15-week aerobic exercise program at either high or low intensity while receiving counseling and nicotine replacement therapy to support smoking cessation.

Weekly exercise sessions totaling 75 minutes per week; up to 5 proactive counseling interactions via phone, chat, or text; nicotine patch use for 8 weeks starting at week 6 (quit day)

Follow-up

Duration - Up to 48 weeks after quit day

Participants are monitored to assess smoking abstinence at 6, 9, and 12 months after the quit attempt.

1 visit at 6 months, 1 visit at 9 months, and 1 visit at 12 months (in-person or remote assessments)

Trial Site Locations

Total: 1 location

1

University of Texas at Austin

Austin, Texas, United States, 78712

Actively Recruiting

Loading map...

Research Team

M

Marla I Sarmiento, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

ACT on Vaping: Digital Therapeutic for Young Adult Vaping Ce...

Nicotine Dependence

Actively Recruiting

1 location

Investigating Efficacious E-Cigarette Interventions and Cess...

E-cigarette Use

Actively Recruiting

2 locations

The Effect of Flavor and Nicotine Strength on the Abuse Liab...

Nicotine Dependence

Actively Recruiting

2 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here