American Indian Smokefree Native RCT

University of Minnesota (UMN)

Status: Enrolling

Conditions: Smoking Cessation

Treatments: Other: Cultural Smoking Cessation Program; Other: Smoking Cessation Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06544811

2024LS126

Details and patient eligibility

About

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.

Full description

This is a two-arm, parallel group, randomized controlled clinical trial. Eligible participants (n=416) will be randomized to either the culturally aligned resource or the general audience version. Participants will use the assigned resource for 6 months, and partake in surveys at baseline, and 1, 3 and 6 months, during which they will be asked several questions related to use of their assigned resource, and smoking behavior. Carbon monoxide (CO) in exhaled breath will be collected at 1, 3 and 6 months using iCO™ Smokerlyzer® (https://www.icoquit.com/us/).

Enrollment: 416 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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416 participants in 2 patient groups, including a placebo group

Tailored

Active Comparator group

Description:

Tailored texting program for quit smoking

Treatment:

Other: Cultural Smoking Cessation Program

Standard

Placebo Comparator group

Description:

Standard texting program for quit smoking

Treatment:

Other: Smoking Cessation Program