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NCT Number: NCT06697496

A Smartphone Application (QuitBot) for the Improvement of Smoking Cessation Among American Indians and Alaska Natives, NAITIVE Trial

This clinical trial develops a chatbot smartphone application (app), QuitBot, and text messaging to help American Indians (AI) and Alaska Natives (AN) to quit smoking commercial tobacco (smoking cessation), and evaluates two remote smoking cessation programs to see how well they work for helping AI/AN people quit smoking commercial tobacco. AI/AN populations have one of the highest rates of commercial cigarette smoking of any racial and ethnic group in the United States (US). They also have a higher rate of developing smoking-related cancer but are less likely to quit smoking. The two programs are designed to provide personalized support in setting a smoking cessation goal, tasks to reach the smoking cessation goal, and motivation to remain smoke-free. This may help to keep participants engaged and support them in their quit efforts, and may improve smoking cessation among AI and AN.

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Key information

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 contact

Jonathan Bricker, PhD

CONTACT

[email protected]

206-667-5074

Jonathan Bricker, PhD

PRINCIPAL_INVESTIGATOR

About this study

OUTLINE: Participants are randomized to 1 of 2 arms. Both groups receive access to a 42-day quit smoking program.

ARM I: Participants receive daily QuitBot program chatbot messages about the importance of quitting smoking, setting a quit date, preparing to quit, quitting, and maintaining abstinence over 42 days.

ARM II: Participants receive daily QuitBot text messages about the importance of quitting smoking, setting a quit date, preparing to quit, quitting, and maintaining abstinence over 42 days.

After completion of study intervention, participants are followed up at 3, 6, and 12 months and may be contacted thereafter for up to 24 months.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Self-identifying as American Indian or Alaska Native, either alone or in combination with other races
  • Age 18 and older
  • Smoking combustible cigarettes daily in the past year
  • Interest in quitting smoking
  • Interest in learning skills to quit smoking
  • Willing to be randomly assigned
  • Have daily access to their own Android or iPhone smartphone
  • Ability to download a smartphone app
  • Ability to read English
  • Not currently (i.e., within past 30 days) using other smoking cessation interventions
  • No prior participation in our studies
  • No prior use of SFT
  • No household or family member participating
  • US residency for the next twelve months
  • Willingness to complete follow-up assessments at the 3-, 6-, and 12-month follow-ups
  • Providing email, phone number(s), and mailing address

Exclusion criteria

  • The reverse of the inclusion criteria
  • Pregnant or breastfeeding
  • Use of other tobacco products (e.g., ceremonial use of tobacco, e-cigarettes) will be assessed but is not an exclusion criterion, as it would limit the study's generalizability

Treatment and study plan

QuitBot Smoking Cessation Chatbot Program

Device

Participate in Quitbot chatbot program

Other names: QuitBot chatbot program

QuitBot Smoking Cessation Text Messaging Program

Device

Participate in Quitbot texting program

Other names: QuitBot texting program

Survey Administration

Other

Ancillary studies

interview

Other

Ancillary studies

Carbon Monoxide Measurement

Procedure

Ancillary studies

Other names: CMONOX

Primary outcomes

  1. 30-day point prevalence abstinence (PPA)

    Time frame: At 12-months post-randomization

    Will use a logistic regression model and standard smoking cessation trial intent-to-treat analysis, with all missing outcomes will be coded as smoking. The model will adjust for stratification factors and baseline factors that are significantly related to the outcome. Sensitivity analyses will include: (1) multiple imputation of missing outcomes, (2) complete case analysis, and (3) carbon monoxide (CO)-verified results adjusted for use of other combustible nicotine-containing tobacco products at the 12-month follow-up-in order to differentiate them from use of cigarettes at 12 months.

Secondary outcomes

  1. 30-day PPA

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

    Also 24-hour and 7-day PPA at the 3-, 6-, and 12- month follow-ups. Will use a logistic regression model and standard smoking cessation trial intent-to-treat analysis, with all missing outcomes will be coded as smoking. The model will adjust for stratification factors and baseline factors that are significantly related to the outcome. Sensitivity analyses will include: (1) multiple imputation of missing outcomes, (2) complete case analysis, and (3) CO-verified results adjusted for use of other combustible nicotine-containing tobacco products at the 12-month follow-up-in order to differentiate them from use of cigarettes at 12 months.

  2. Measures of bond between user and conversational chatbot

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

    Will be measured via four subscales of the 12-item Working Alliance Inventory for Tobacco (WAIT-12), with technology intervention adaptations similar to those of prior chatbot research. Will calculate the proportion of treatment effect explained by each of the mediators. Number of times participants engaged with the intervention will be adjusted in Poisson regressions that account for the number of prompts a participant received.

  3. Agreement on goals of treatment

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

    Will be measured via four subscales of the WAIT-12, with technology intervention adaptations similar to those of prior chatbot research. Will calculate the proportion of treatment effect explained by each of the mediators.

  4. Agreement on tasks of treatment

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

    Will be measured via four subscales of the WAIT-12, with technology intervention adaptations similar to those of prior chatbot research. Will calculate the proportion of treatment effect explained by each of the mediators.

  5. User's sense that QuitBot understands their needs

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

    Will be measured via four subscales of the WAIT-12, with technology intervention adaptations similar to those of prior chatbot research. Will calculate the proportion of treatment effect explained by each of the mediators.

Study contacts

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

Jonathan Bricker, PhD

CONTACT

[email protected]

206-667-5074

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Navigation and Artificial Intelligence Technology for Indigenous Virtual Education on Smoking Cessation (NAITIVE)

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Nov 20, 2024
Registry last updated
Jun 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.

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