Smoking Cessation
Conditions
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/).
Interventions
A free text message smoking cessation program that provides 24/7 encouragement, advice, and tips to those trying to quit smoking.
OTHERCultural Smoking Cessation Program
A free text message smoking cessation program that provides 24/7 encouragement, advice, and tips to those trying to quit smoking and has been developed for American Indian and Alaska Native persons.
Sponsors
Masonic Cancer Center, University of Minnesota
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Two-condition, parallel group, RCT design, will examine the efficacy of a culturally aligned digital quit resource versus a general audience version of the resource. This is a multi-site study that will involve participants engaging with their assigned quit resource, and following up with them during months 1, 3 and 6.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 months |
| Percent 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 |
Countries
United States
Contacts
CONTACTDana Carroll, PhD
Outcome results
None listed