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

NCT ID: NCT06697496

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 772 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-01
• Study Completion Date: 2030-10-31

Brief Summary

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.

Detailed Description

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.

Conditions

Cigarette Smoking-Related Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Arm I (QuitBot chatbot)

Participants participate in the QuitBot program which involves chatbot messages over 42 days. Therapy description withheld to protect the integrity of the study.

Group Type: EXPERIMENTAL

QuitBot Smoking Cessation Chatbot Program

Intervention Type: DEVICE

Participate in Quitbot chatbot program

Survey Administration

Intervention Type: OTHER

Ancillary studies

Interview

Intervention Type: OTHER

Ancillary studies

Carbon Monoxide Measurement

Intervention Type: PROCEDURE

Ancillary studies

Arm II (QuitBot texting)

Participants participate in the QuitBot program which involves text messages over 42 days. Therapy description withheld to protect the integrity of the study.

Group Type: ACTIVE_COMPARATOR

QuitBot Smoking Cessation Text Messaging Program

Intervention Type: DEVICE

Participate in Quitbot texting program

Survey Administration

Intervention Type: OTHER

Ancillary studies

Carbon Monoxide Measurement

Intervention Type: PROCEDURE

Ancillary studies

Interventions

QuitBot Smoking Cessation Chatbot Program

Participate in Quitbot chatbot program

Intervention Type: DEVICE

QuitBot Smoking Cessation Text Messaging Program

Participate in Quitbot texting program

Intervention Type: DEVICE

Survey Administration

Ancillary studies

Intervention Type: OTHER

Interview

Ancillary studies

Intervention Type: OTHER

Carbon Monoxide Measurement

Ancillary studies

Intervention Type: PROCEDURE

Other Intervention Names

QuitBot chatbot program; QuitBot texting program; CMONOX

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Bricker, PhD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Countries

United States

Central Contacts

Jonathan Bricker, PhD

Role: CONTACT

jbricker@fredhutch.org

206-667-5074

Facility Contacts

Jonathan Bricker, PhD

Role: primary

jbricker@fredhutch.org

206-667-5074

Other Identifiers

NCI-2024-08892

Identifier Type: REGISTRY

Identifier Source: secondary_id

U19MD020533

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FHIRB0020651

Identifier Type: OTHER

Identifier Source: secondary_id

RG1124884

Identifier Type: -

Identifier Source: org_study_id