NCT06544811

American Indian Smokefree Native RCT

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 416 (estimated)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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/).

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2025-04-14
• Primary completion: 2029-01-01
• Completion: 2029-10-01
• First posted: 2024-08-09
• Last updated: 2025-07-16

Locations

1 site across 1 country: United States