Nicotine Dependence
Conditions
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?
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.
Interventions
BEHAVIORALAerobic 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.
BEHAVIORALCounseling
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.
DRUGNicotine 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
Jasper A. Smits
University of Houston
University of Oklahoma
National Cancer Institute (NCI)
YMCA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-day point prevalence abstinence (PPA) at 6-month follow-up | Protocol week 30, which is 24 weeks (6 months) after the quit attempt (set at week 6) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 7-day point prevalence abstinence (PPA) at 12-month follow-up | Protocol week 54, which is 48 weeks (12 months) after the quit attempt (set at week 6) | 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. |
| 7-day point prevalence abstinence (PPA) at 9-month follow-up | Protocol week 42, which is 36 weeks (9 months) after the quit attempt (set at week 6) | 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. |
Countries
United States
Contacts
CONTACTMarla I Sarmiento, BS
PRINCIPAL_INVESTIGATORJasper Smits, PhD
University of Texas at Austin
Outcome results
None listed