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Recruiting NCT06544811

American Indian Smokefree Native RCT

No phase Interventional Smoking Cessation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Smoking Cessation Program, Cultural Smoking Cessation Program.
Who it may be relevant to
Registry conditions: Smoking Cessation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Randomized Clinical Trial of A Culturally Aligned Digital Smoking Cessation Resource for American Indian Persons

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.

Detailed 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/).

Interventions

  • Other Smoking Cessation Program
    A free text message smoking cessation program that provides 24/7 encouragement, advice, and tips to those trying to quit smoking.
  • Other Cultural Smoking Cessation Program
    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.

Primary outcome measures

  • Percent of participants that are biochemically confirmed 7-day abstinence from from all combustible tobacco products with a negative breath CO test [Time frame: 6 months]
Secondary outcome measures (10)
  • Percent of participants that are biochemically-confirmed 7-day abstinence [Time frame: 1 and 3 months]
  • Percent of participants that self-report 24-hour abstinence [Time frame: 1, 3, and 6 months]
  • Percent of participants that self-report 7-day abstinence [Time frame: 1, 3, and 6 months]
  • Percent of participants that self-report 30-day abstinence [Time frame: 3 and 6 months]
  • Mean cigarettes per day in past 7 days [Time frame: 1, 3, and 6 months]
  • Number of 24-hour quit attempts in past 30 days [Time frame: 1, 3, and 6 months]
  • Percent of participants that used nicotine replacement therapy and pharmacotherapy [Time frame: 1, 3, and 6 months]
  • Percent of participants that used other behavioral support [Time frame: 1, 3, and 6 months]
  • Percent of participants that used other commercial tobacco products [Time frame: 1, 3, and 6 months]
  • Mean cigarette dependence [Time frame: 1, 3, and 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Masonic Cancer Center — Minneapolis

Identifiers

NCT: NCT06544811 · 2024LS126

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗