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NCT Number: NCT06544811

American Indian Smokefree Native RCT

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Dana Carroll, PhD, MPH

CONTACT

About this study

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/).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smoking cessation program

Other

A free text message smoking cessation program that provides 24/7 encouragement, advice, and tips to those trying to quit smoking.

Cultural Smoking Cessation Program

Other

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.

Primary outcomes

  1. Percent of participants that are biochemically confirmed 7-day abstinence from from all combustible tobacco products with a negative breath CO test

    Time frame: 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 outcomes

  1. Percent of participants that are biochemically-confirmed 7-day abstinence

    Time frame: 1 and 3 months

    Percent of participants that are biochemically-confirmed 7-day abstinence at 1, 3 months

  2. Percent of participants that self-report 24-hour abstinence

    Time frame: 1, 3, and 6 months

    Percent of participants that self-report 24-hour abstinence at 1, 3, and 6 months

  3. Percent of participants that self-report 7-day abstinence

    Time frame: 1, 3, and 6 months

    Percent of participants that self-report 7-day abstinence at 1, 3, and 6 months

  4. Percent of participants that self-report 30-day abstinence

    Time frame: 3 and 6 months

    Percent of participants that self-report 30-day abstinence at 3 and 6 months

  5. Mean cigarettes per day in past 7 days

    Time frame: 1, 3, and 6 months

    Change in mean cigarettes per day in past 7 days at 1, 3, and 6 months

  6. Number of 24-hour quit attempts in past 30 days

    Time frame: 1, 3, and 6 months

    Number of 24-hour quit attempts in past 30 days at 1, 3, and 6 months

  7. Percent of participants that used nicotine replacement therapy and pharmacotherapy

    Time frame: 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

  8. Percent of participants that used other behavioral support

    Time frame: 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

  9. Percent of participants that used other commercial tobacco products

    Time frame: 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

  10. Mean cigarette dependence

    Time frame: 1, 3, and 6 months

    mean cigarette dependence at 1, 3, and 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Dana Carroll, PhD

CONTACT

[email protected]

612-624-0132

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Collaborators

  • University of Minnesota

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Aug 9, 2024
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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