Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06145763

A Digital Smoking Cessation Intervention for Helping American Indians and Alaska Natives Quit Smoking, IndigeQuit Trial

This clinical trial compares a new smoking cessation smartphone application (app) (IndigeQuit) to an existing smarphone app (National Cancer Institute [NCI] QuitGuide) for helping American Indians and Alaska Natives (AI/ANs) quit smoking. Compared to other racial/ethnic groups, AIANs have 6 times higher rates of developing smoking-related cancers, including lung cancer. Commercial cigarette smoking accounts for half of all deaths among AIANs nationwide. AIANs' often lack of access to smoking cessation interventions, which may be due to inequities in the healthcare system, lack of health insurance, living in rural areas, systemic racism, and historical trauma. There is also a lack of effective smoking cessation interventions for AIANs. Smartphone apps have the potential to deliver a low-cost smoking cessation intervention with wide reach to AIANs. Apps require no in-person delivery and no provider training, do not require integration into complex hospital systems, can be freely accessed on an app store, and are available at any time and any place. IndigeQuit is a behavioral intervention designed to help adults stop smoking by teaching skills for coping with smoking urges, staying motivated, and preventing relapse. The IndigeQuit app intervention may be more effective than the currently available NCI QuitGuide app at helping AIANs quit smoking.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cigarette Smoking-Related Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location status: Recruiting

Location contact

Brie Sullivan

CONTACT

[email protected]

206-667-5238

Jonathan B. Bricker

PRINCIPAL_INVESTIGATOR

About this study

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants use the IndigeQuit app, which includes setting up a personalized quit plan, participating in eight levels of the content, receiving on-demand help in coping with smoking urges, and tracking their daily smoking behaviors for at least 45 days on study.

ARM II: Participants use the NCI QuitGuide app for at least 45 days on study.

After completion of study intervention, patients are followed up at 3, 6, and 12-months.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Self-identify as American Indian or Alaska Native, either alone or in combination with other races
  • Age 18 and older
  • Has smoked daily for the past year
  • Interest in quitting smoking within the next 30 days
  • Willing to be randomly assigned to either app
  • Have daily access to their own Android or iPhone
  • Able to download a smartphone app
  • Be willing and able to read English
  • Not currently or within past 30 days using other smoking cessation behavioral interventions or smoking cessation pharmacotherapies
  • Have never participated in our prior research
  • Have no other household or family member participating
  • Being willing to complete the 3, 6, and 12-month follow-up assessments
  • Providing email, phone number(s), and mailing address
  • Living off United States (US) AI/AN tribal reservations or living on five Northern Plains tribal reservations from whom we would obtain approvals to recruit

Exclusion criteria

  • Currently (i.e., within past 30 days) using other smoking cessation behavioral interventions
  • Has participated in our prior research trials
  • Has used the National Cancer Institute's (NCI's) QuitGuide app
  • Not willing to complete a follow-up survey at 3, 6, and 12 months post-randomization
  • Not providing email, phone number(s), and mailing address

Treatment and study plan

Biospecimen Collection

Procedure

Ancillary studies

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Smoking Cessation Intervention

Behavioral

Use IndigeQuit smartphone app

Other names: Smoking and Tobacco Use Cessation Interventions

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. 30-day point prevalence abstinence (PPA)

    Time frame: At 12 months post randomization

    Will be assessed based on self-report with biochemical verification of salivary cotinine. For each comparison of treatment arms on cessation outcomes, will use a logistic regression model.

Secondary outcomes

  1. 30-day PPA

    Time frame: At 3- and 6-months post randomization

    Will be assessed based on self-report with biochemical verification of salivary cotinine. For each comparison of treatment arms on cessation outcomes, will use a logistic regression model.

  2. Self-reported 24-hour PPA

    Time frame: At the 3, 6, and 12-month follow-ups

    A secondary definition of cessation will include self-reported abstinence from cigarettes and all other commercial nicotine-containing tobacco products (i.e., e-cigarettes or vaping, chewing tobacco, snus, hookahs, cigars, cigarillos, tobacco pipes, kreteks). Will be assessed based on self-report with biochemical verification of salivary cotinine. For each comparison of treatment arms on cessation outcomes, will use a logistic regression model.

  3. Self-reported 7-day PPA

    Time frame: At the 3, 6, and 12-month follow-ups

    A secondary definition of cessation will include self-reported abstinence from cigarettes and all other commercial nicotine-containing tobacco products (i.e., e-cigarettes or vaping, chewing tobacco, snus, hookahs, cigars, cigarillos, tobacco pipes, kreteks). Will be assessed based on self-report with biochemical verification of salivary cotinine. For each comparison of treatment arms on cessation outcomes, will use a logistic regression model.

Study contacts

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

Brie Sullivan

CONTACT

[email protected]

206-667-5238

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Digital Smoking Cessation Intervention for Nationally-Recruited American Indians and Alaska Natives: A Full-Scale Randomized Controlled Trial (IndigeQuit)

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 24, 2023
Registry last updated
Feb 9, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.