American Indian Smokefree Native RCT

Randomized Clinical Trial of A Culturally Aligned Digital Smoking Cessation Resource for American Indian Persons

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.

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation
• Intervention / Treatment: Other: Cultural Smoking Cessation Program; Other: Smoking Cessation Program

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/).

• Study Type: Interventional
• Enrollment (Estimated): 416
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dana Carroll, PhD; Phone Number: 612-624-0132; Email: dcarroll@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • Masonic Cancer Center
      • Contact: Dana Carroll, PhD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tailored; Tailored texting program for quit smoking	Other: Cultural 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.
Placebo Comparator: Standard; Standard texting program for quit smoking	Other: Smoking Cessation Program; A free text message smoking cessation program that provides 24/7 encouragement, advice, and tips to those trying to quit smoking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of participants that are biochemically confirmed 7-day abstinence from from all combustible tobacco products with a negative breath CO test	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).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of participants that are biochemically-confirmed 7-day abstinence	Percent of participants that are biochemically-confirmed 7-day abstinence at 1, 3 months	1 and 3 months
Percent of participants that self-report 24-hour abstinence	Percent of participants that self-report 24-hour abstinence at 1, 3, and 6 months	1, 3, and 6 months
Percent of participants that self-report 7-day abstinence	Percent of participants that self-report 7-day abstinence at 1, 3, and 6 months	1, 3, and 6 months
Number of 24-hour quit attempts in past 30 days	Number of 24-hour quit attempts in past 30 days at 1, 3, and 6 months	1, 3, and 6 months
Percent of participants that used nicotine replacement therapy and pharmacotherapy	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	1, 3, and 6 months
Percent of participants that used other behavioral support	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	1, 3, and 6 months
Percent of participants that self-report 30-day abstinence	Percent of participants that self-report 30-day abstinence at 3 and 6 months	3 and 6 months
Mean cigarettes per day in past 7 days	Change in mean cigarettes per day in past 7 days at 1, 3, and 6 months	1, 3, and 6 months
Percent of participants that used other commercial tobacco products	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	1, 3, and 6 months
Mean cigarette dependence	mean cigarette dependence at 1, 3, and 6 months	1, 3, and 6 months

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota
• Collaborators: University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: July 11, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2024LS126

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No