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IndigeQuit: Protocol for a Randomized Clinical Trial of a Culturally Adapted Smoking Cessation App for American Indian and Alaska Native Adults
ABSTRACT
Background:
Gaps in access to effective, culturally relevant cessation support among American Indian and Alaska Native (AI/AN) communities have contributed to poor cessation outcomes, and consequently, to smoking-related health inequities.
Objective:
Here we describe the protocol for a randomized clinical trial (RCT) that is testing the efficacy of a culturally adapted smoking cessation app (IndigeQuit) developed specifically to help AI/AN adults quit commercial cigarette smoking relative to a standard, non-tailored app (QuitGuide).
Methods:
To improve the relevance and acceptability of cessation support to AI/AN adults, IndigeQuit was developed through a cultural adaptation of iCanQuit, an evidence-based smartphone application grounded in acceptance and commitment therapy that teaches skills for accepting cravings to smoke. The cultural adaptation followed a community-based participatory research mixed methods approach with a Community Advisory Board (CAB) of AI/AN individuals. Cultural adaptations included the use of Native imagery, stories featuring AI/AN adults and elders emphasizing culture, spirituality, family, and community, and the important distinction between ceremonial and commercial tobacco. A total of 776 AI/AN adults who smoke and want to quit are being recruited nationwide and randomized to receive IndigeQuit or QuitGuide for 12 months. The primary aim of the RCT is to determine the efficacy of IndigeQuit vs QuitGuide for 30-day abstinence at 12 months. Secondary aims include abstinence at earlier timepoints, identifying mediators and moderators of treatment effects, and assessing engagement and satisfaction. Qualitative interviews with IndigeQuit participants and CAB members will inform the development of a subsequent guide to support the broad dissemination of IndigeQuit nationwide.
Results:
The National Institute of Cancer funded this study in 2024 (R01 CA284687, Principal Investigator, JBB). As of May 2026, 353 AI/AN adults had been enrolled in the trial. Enrollment is expected to be completed by November 2028.
Conclusions:
The IndigeQuit app was designed to deliver evidence-based smoking cessation treatment that is culturally adapted to AI/AN and grounded in Acceptance and Commitment Therapy. If effective, this intervention could offer a more scalable and culturally relevant treatment to AI/AN communities nationwide, helping to reduce smoking-related health inequities. Clinical Trial: ClinicalTrials.gov Identifier, NCT06145763; https://clinicaltrials.gov/study/NCT06145763
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