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American Indian Smokefree Native RCT

ConditionSmoking Cessation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMasonic Cancer Center, University of Minnesota

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Smoking Cessation Program

    Other intervention

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

  • Cultural Smoking Cessation Program

    Other intervention

    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.

Treatment groups

416 Participants
are divided into 2 treatment groups
Group A: TailoredActive comparator 1 intervention
Group B: StandardPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Masonic Cancer Center, University of Minnesota

Lead sponsor

University of Minnesota

Collaborator

Source ClinicalTrials.gov
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