Community-based Smoking Cessation Treatment for Adults With High Stress Sensitivity. (STEP3)

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

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?

Study Overview

• Status: Recruiting
• Conditions: Nicotine Dependence
• Intervention / Treatment: Behavioral: Aerobic Exercise; Behavioral: Counseling; Drug: Nicotine patch

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Marla I Sarmiento, BS; Phone Number: 915-502-9979; Email: sarmimar@utexas.edu
• Study Contact Backup: Name: Sydney Thureen, BS; Phone Number: 610-719-7952; Email: sthureen@utexas.edu

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • Recruiting
      • University of Texas at Austin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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]).
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.	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]).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Jasper A. Smits
• Collaborators: National Cancer Institute (NCI); University of Oklahoma; University of Houston; YMCA
• Investigators: Principal Investigator: Jasper Smits, PhD, University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: September 7, 2023
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2016120049; R01CA273221 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Within one year of completion (publication) of the primary aims for this project, we will provide de-identified data from this project to interested researchers. The data are to be provided in a SPSS file or Excel, with separate documentation of labels/characteristics for each column of data. Data will be released directly by Dr. Smits's team at UT to investigators providing evidence of their institution's IRB approval for planned analyses of the data.
• IPD Sharing Time Frame: Within one year of completion (publication) of the primary aims. No end date.
• IPD Sharing Access Criteria: Data will be released directly by Dr. Smits's team at UT to investigators providing evidence of their institution's IRB approval for planned analyses of the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No