Community-based Smoking Cessation Treatment for Adults With High Stress Sensitivity.
NCT06053567 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360
Last updated 2026-05-15
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
Interventions
- BEHAVIORAL
-
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.
- BEHAVIORAL
-
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.
- DRUG
-
Nicotine patch
On the target quit day (week 6), participants will be provided 8 weeks of nicotine replacement therapy (24-hour transdermal nicotine patches \[TNP\]).
Sponsors & Collaborators
-
University of Houston
collaborator OTHER -
University of Oklahoma
collaborator OTHER -
National Cancer Institute (NCI)
collaborator NIH -
YMCA
collaborator OTHER -
Jasper A. Smits
lead OTHER
Principal Investigators
-
Jasper Smits, PhD · University of Texas at Austin
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-12-27
- Primary Completion
- 2029-03-31
- Completion
- 2029-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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