Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06544811

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

Led by Masonic Cancer Center, University of Minnesota · Updated on 2025-07-16

416

Participants Needed

1

Research Sites

39 weeks

Total Duration

On this page

Sponsors

M

Masonic Cancer Center, University of Minnesota

Lead Sponsor

U

University of Minnesota

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a culturally aligned digital smoking cessation program designed specifically for American Indian and Alaska Native persons who smoke. This randomized controlled trial compares this culturally tailored resource to a general, standard smoking cessation text messaging program. The study aims to examine the effectiveness of these programs in helping participants quit smoking combustible tobacco products. Participants will be randomly assigned to one of two groups: one receiving the culturally aligned smoking cessation text message program and the other receiving the standard text message program. Both groups will use their assigned program for six months. The study includes surveys at the start and at 1, 3, and 6 months to gather information about program use and smoking behavior. Additionally, carbon monoxide levels in exhaled breath will be measured at 1, 3, and 6 months using a specialized device to biochemically confirm smoking abstinence. During the study, participants will complete questionnaires about their smoking habits and program usage. Researchers will track smoking abstinence rates confirmed by breath tests after six months as the main outcome. Secondary measures include abstinence rates at earlier time points, self-reported quit attempts, cigarette use, and use of nicotine replacement or other support methods. Participation lasts for six months, with ongoing monitoring through surveys and breath tests to assess quitting success and program engagement.

CONDITIONS

Brief Title

American Indian Smokefree Native RCT

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Self-identify as American Indian or Alaska Native
  • Be 18 years of age or older with photo ID confirmation
  • Smoke an average of at least 3 cigarettes per day in the past 30 days
  • Be considering or willing to make a quit attempt
  • Have daily access to a personal iPhone, Android smartphone, or tablet capable of receiving messages
  • Be able to read and speak English
Not Eligible

You will not qualify if you...

  • None

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or virtual) for eligibility confirmation

Treatment

Duration - 6 months

Participants use either a culturally aligned or standard smoking cessation text messaging program for 6 months to support quitting smoking.

Surveys and breath CO measurements at 1, 3, and 6 months

Trial Site Locations

Total: 1 location

1

Masonic Cancer Center

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

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Research Team

D

Dana Carroll, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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