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

Part of paid clinical trials in Austin, Texas.

Sponsor
Jasper A. Smits
Study ID
NCT06053567
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Nicotine Dependence

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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?

Key Dates

Start date
Dec 27, 2023
Status verified
May 2026
Primary completion
Mar 31, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas at AustinAustinTexas78712-

Find similar trials in Austin, TX

By research site
University of Texas at Austin· Austin, TX

Related Studies