American Indian Smokefree Native RCT

NCT06544811 | Recruiting DMC

• 1 other identifier: 2024LS126
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Outcome Measures

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

  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 Outcomes (10)

• Percent of participants that are biochemically-confirmed 7-day abstinence

  1 and 3 months

• Percent of participants that self-report 24-hour abstinence

  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 30-day abstinence

  3 and 6 months

• Mean cigarettes per day in past 7 days

  1, 3, and 6 months

Study Arms (2)

Tailored

ACTIVE COMPARATOR

Tailored texting program for quit smoking

Other: Cultural Smoking Cessation Program

Standard

PLACEBO COMPARATOR

Standard texting program for quit smoking

Other: Smoking Cessation Program

Interventions

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.

Standard

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.

Tailored

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead
• University of Minnesota: collaborator

Study Sites (1)

Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Central Study Contacts

Dana Carroll, PhD

CONTACT

612-624-0132; dcarroll@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-condition, parallel group, RCT design, will examine the efficacy of a culturally aligned digital quit resource versus a general audience version of the resource. This is a multi-site study that will involve participants engaging with their assigned quit resource, and following up with them during months 1, 3 and 6.

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 9, 2024
• Study Start: April 14, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

US (1)