American Indian Smokefree Native RCT

Masonic Cancer Center, University of Minnesota416 enrolled

Overview

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.

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/).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

416

Conditions

Smoking Cessation

Interventions

Smoking Cessation ProgramOTHER

A free text message smoking cessation program that provides 24/7 encouragement, advice, and tips to those trying to quit smoking.

Cultural Smoking Cessation ProgramOTHER

A free text message smoking cessation program that provides 24/7 encouragement, advice, and tips to those trying to quit smoking and has been developed for American Indian and Alaska Native persons.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Masonic Cancer Center

Minneapolis, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

Percent of participants that are biochemically confirmed 7-day abstinence from from all combustible tobacco products with a negative breath CO test

Percent of participants that are biochemically confirmed 7-day abstinence from all combustible tobacco products (defined as self-reported abstinence during the past seven days \[not even a puff of cigarettes, cigars, hookah, or pipe tobacco\] with a negative breath CO test ≤ 4 ppm).

Time frame: 6 months

Secondary Outcomes

Percent of participants that are biochemically-confirmed 7-day abstinence

Percent of participants that are biochemically-confirmed 7-day abstinence at 1, 3 months

Time frame: 1 and 3 months

Percent of participants that self-report 24-hour abstinence

Percent of participants that self-report 24-hour abstinence at 1, 3, and 6 months

Time frame: 1, 3, and 6 months

Percent of participants that self-report 7-day abstinence

Percent of participants that self-report 7-day abstinence at 1, 3, and 6 months

Time frame: 1, 3, and 6 months

Percent of participants that self-report 30-day abstinence

Percent of participants that self-report 30-day abstinence at 3 and 6 months

Time frame: 3 and 6 months

Mean cigarettes per day in past 7 days

Change in mean cigarettes per day in past 7 days at 1, 3, and 6 months

Time frame: 1, 3, and 6 months

Number of 24-hour quit attempts in past 30 days

Number of 24-hour quit attempts in past 30 days at 1, 3, and 6 months

Central Contacts

Dana Carroll, PhD

CONTACT

612-624-0132 dcarroll@umn.edu

Data from ClinicalTrials.gov

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