American Indian Smokefree Native RCT

Not Applicable

Recruiting

• Conditions: Smoking Cessation
• Interventions: Other: Smoking Cessation Program; Other: Cultural Smoking Cessation Program

• 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

Not available

Study Timeline

• Study First Submitted: 2024-08-05
• Study First Submitted QC: 2024-08-05
• Study First Posted: 2024-08-09
• Status Verified: 2025-04
• Study Start: 2025-04-14
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-20
• Primary Completion: 2029-01-01
• Study Completion: 2029-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 416

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard	Smoking Cessation Program	Standard texting program for quit smoking
Tailored	Cultural Smoking Cessation Program	Tailored texting program for quit smoking

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 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

Trial Locations

Locations (1)

Masonic Cancer Center; 🇺🇸 Minneapolis, Minnesota, United States