American Indian Smokefree Native RCT
- Conditions
- Smoking Cessation
- Registration Number
- NCT06544811
- Lead Sponsor
- Masonic Cancer Center, University of Minnesota
- Brief Summary
The aim of this clinical trial is to test the efficacy of a culturally aligned digital smoking cessation resource for American Indian persons who smoke, via a remotely conducted randomized controlled trial.
- Detailed Description
This is a two-arm, parallel group, randomized controlled clinical trial. Eligible participants (n=416) will be randomized to either the culturally aligned resource or the general audience version. Participants will use the assigned resource for 6 months, and partake in surveys at baseline, and 1, 3 and 6 months, during which they will be asked several questions related to use of their assigned resource, and smoking behavior. Carbon monoxide (CO) in exhaled breath will be collected at 1, 3 and 6 months using iCO™ Smokerlyzer® (https://www.icoquit.com/us/).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 416
- AI race based on self-report;
- ≥ 18 years of age via photo ID confirmation;
- Average smoked cigarettes per day, ≥ 3 in the past 30 days;
- considering or willing to make a quit attempt;
- self-report having daily access to their own iPhone/Android smartphone or tablet that allows for messaging use;
- able to read and speak English.
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percent of participants that are biochemically confirmed 7-day abstinence from from all combustible tobacco products with a negative breath CO test 6 months Percent of participants that are biochemically confirmed 7-day abstinence from all combustible tobacco products (defined as self-reported abstinence during the past seven days \[not even a puff of cigarettes, cigars, hookah, or pipe tobacco\] with a negative breath CO test ≤ 4 ppm).
- Secondary Outcome Measures
Name Time Method Percent of participants that are biochemically-confirmed 7-day abstinence 1 and 3 months Percent of participants that are biochemically-confirmed 7-day abstinence at 1, 3 months
Percent of participants that self-report 24-hour abstinence 1, 3, and 6 months Percent of participants that self-report 24-hour abstinence at 1, 3, and 6 months
Percent of participants that self-report 7-day abstinence 1, 3, and 6 months Percent of participants that self-report 7-day abstinence at 1, 3, and 6 months
Percent of participants that self-report 30-day abstinence 3 and 6 months Percent of participants that self-report 30-day abstinence at 3 and 6 months
Mean cigarettes per day in past 7 days 1, 3, and 6 months Change in mean cigarettes per day in past 7 days at 1, 3, and 6 months
Number of 24-hour quit attempts in past 30 days 1, 3, and 6 months Number of 24-hour quit attempts in past 30 days at 1, 3, and 6 months
Percent of participants that used nicotine replacement therapy and pharmacotherapy 1, 3, and 6 months Percent of participants that used nicotine replacement therapy and pharmacotherapy (e.g.
nicotine patch, Chantix) in past 30 days at 1, 3, and 6 monthsPercent of participants that used other behavioral support 1, 3, and 6 months Percent of participants that used other behavioral support (e.g. in-person, quitline) for smoking cessation in past 30 days at 1, 3, and 6 months
Percent of participants that used other commercial tobacco products 1, 3, and 6 months Percent of participants that used other commercial tobacco products (e.g., smokeless tobacco, e-cigarettes) in the past 7 days 1, 3, and 6 months
Mean cigarette dependence 1, 3, and 6 months mean cigarette dependence at 1, 3, and 6 months
Trial Locations
- Locations (1)
Masonic Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Masonic Cancer Center🇺🇸Minneapolis, Minnesota, United StatesDana Carroll, PhD, MPHContact