Recruiting
Phase 3

Smoking Cessation

Sponsor:

Jasper A. Smits

Code:

NCT06053567

Conditions

Nicotine Dependence

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Aerobic Exercise

Counseling

Nicotine patch

Study Details

Brief summary:

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?

Conditions

Nicotine Dependence

Study ID

NCT06053567

Start date

Dec 27, 2023

Status verified date

May, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adult (age ≥ 18);
  • High Anxiety Sensitivity (≥5 on the Short Scale Anxiety Sensitivity Index \[SSASI\]);
  • Daily smoker, ≥5 cigarettes (including e-cigarettes, little cigars/cigarillos) for ≥1 year;
  • Motivated to quit smoking as evidenced by a score of ≥5 on a 0-10 Likert scale;
  • Body mass index < 40;
  • Medical clearance to participate.
  • Located near a participating YMCA site (within 50 miles)

Exclusion Criteria:

  • Regular exercise defined as engaging in vigorous-intensity exercise for at least 75 minutes per week for the last 3 months
  • Receiving current intervention for smoking cessation.
  • Outstanding debt to the YMCA
  • Listed as a sex offender on the National Sex Offender Registry

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: High-Intensity Aerobic Exercise

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.

active comparator: Low-Intensity Aerobic Exercise

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.

Interventions

Aerobic Exercise

Participants will select a YMCA branch and will be assigned a personal fitness instructor who will oversee a 15-week exercise intervention. The weekly exercise prescription is 75 minutes of aerobic training.

Counseling

Participants will receive the standard tobacco cessation package of up to 5 proactive interactions from the Texas Tobacco Quitline (TTQ). Interactions are typically phone calls, but can be chat or live text if the participant prefers. Interaction 1 is for assessment and quit date planning, Interaction 2 occurs prior to the quit date and can be a group session, Interaction 3 occurs shortly following the quit date, and Interactions 4 and 5 are for relapse prevention if the smoker has quit or problem solving if they have not quit. TTQ also offers a tobacco cessation text messaging program and access to a web portal with a variety of cessation resources.

Nicotine patch

On the target quit day (week 6), participants will be provided 8 weeks of nicotine replacement therapy (24-hour transdermal nicotine patches \[TNP\]).

Primary outcome measure

  • 7-day point prevalence abstinence (PPA) at 6-month follow-up [ Time Frame: Protocol week 30, which is 24 weeks (6 months) after the quit attempt (set at week 6) ]

Central Contacts and Locations

Central contacts

Marla I Sarmiento, BS

915-502-9979sarmimar@utexas.edu

Locations

University of Texas at Austin

Recruiting

Austin, Texas, United States, 78712

More Information

Sponsor

Jasper A. Smits

Last update posted

May 15, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Jasper A. Smits on 2026-05-15.