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

Nicotine Dependence Clinical Trial

— STEP3  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06053567
• Other study ID #: 2016120049
• Secondary ID: R01CA273221
• Status: Recruiting
• Phase: Phase 3
• Start date: December 27, 2023
• Est. completion date: June 30, 2028

Study information

• Verified date: January 2024
• Source: University of Texas at Austin
• Contact: Marla I Sarmiento, BS
• Phone: 915-502-9979
• Email: sarmimar[@]utexas.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Description:

This protocol provides the recommended treatment to achieve smoking cessation (i.e., counseling and nicotine replacement therapy) and randomly assigns individuals to a high-intensity exercise or low-intensity exercise intervention as a strategy to engage the mechanisms relevant to high anxiety sensitive smokers to improve smoking cessation outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:

• Regular exercise defined as engaging in moderate-intensity exercise =3 days per week for =20 min each time;
• Receiving current intervention for smoking cessation.

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

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.
• 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]).

Locations

Country	Name	City	State
United States	University of Texas at Austin	Austin	Texas

Sponsors (5)

Lead Sponsor	Collaborator
Jasper A. Smits	National Cancer Institute (NCI), University of Houston, University of Oklahoma, YMCA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day point prevalence abstinence (PPA) at 6-month follow-up	Self-report of no smoking (not even a puff) during the previous 7 days, verified by expired carbon monoxide (CO; =5ppm), saliva cotinine (<30 ng/mL), or significant other, and not invalidated by any of these verification measures. Failure to provide any of these 3 verification measures will result in PPA being considered missing.	Protocol week 30, which is 24 weeks (6 months) after the quit attempt (set at week 6)
Secondary	7-day point prevalence abstinence (PPA) at 12-month follow-up	Self-report of no smoking (not even a puff) during the previous 7 days, verified by expired carbon monoxide (CO; =5ppm), saliva cotinine (<30 ng/mL), or significant other, and not invalidated by any of these verification measures. Failure to provide any of these 3 verification measures will result in PPA being considered missing.	Protocol week 54, which is 48 weeks (12 months) after the quit attempt (set at week 6)
Secondary	7-day point prevalence abstinence (PPA) at 9-month follow-up	Self-report of no smoking (not even a puff) during the previous 7 days, verified by expired carbon monoxide (CO; =5ppm), saliva cotinine (<30 ng/mL), or significant other, and not invalidated by any of these verification measures. Failure to provide any of these 3 verification measures will result in PPA being considered missing.	Protocol week 42, which is 36 weeks (9 months) after the quit attempt (set at week 6)