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Completed

NCT Number: NCT06111755

Quit Smoking Text Message Study

This project will address research gaps and advance the science of smoking cessation by conducting a randomized controlled trial of an evidence-based, population-level quit smoking text messaging program with or without a smartband.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National online recruitment

New Haven, Connecticut, 06511, United States

About this study

Aim 1 of this study is to test within-treatment effects for smoking cessation. The primary outcome will be biochemically (cotinine)-confirmed 7-day point-prevalence abstinence (PPA) at end of treatment (8 weeks). Secondary outcomes will be percent days smoke-free, time to relapse, and rated treatment satisfaction.

Aim 2 of this study is to explore sex/gender differences in treatment effects for smoking cessation. Given established sex/gender differences in smoking behavior and cessation,randomization will be stratified by sex/gender and we will measure effects of sex/gender on outcomes. Effect sizes will be estimated for smoking outcomes by sex.

Outcomes will be evaluated for those who complete enrollment, defined as those who complete study onboarding.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • daily smokers for at least 6 months
  • report an interest in quitting smoking.

Exclusion criteria

  • reporting being currently enrolled in another quit smoking program

Treatment and study plan

SmokefreeTXT

Other

National Cancer Institute's SmokefreeTXT is a text message quit smoking program available nationally. Users sign up and choose a target quit date that is within 2 weeks of their signup date. Users receive 3-5 text messages per day for up to 2 weeks pre-quit and 6 weeks post-quit. The quit date can be reset as often as needed by the user.

Smartband

Device

A smartband that will track smoking in real-time and ask the individual to confirm/deny smoking. Participants will be asked to wear the smartband during their waking hours and to charge it overnight.

Primary outcomes

  1. Number of participants with cotinine confirmed 7-day point-prevalence abstinence (PPA) at end of treatment (8 weeks)

    Time frame: 8 weeks

    7-day PPA at end of treatment with be confirmed via cotinine testing in saliva

Secondary outcomes

  1. Change in cigarettes smoked per day

    Time frame: baseline, 4 weeks and 8 weeks

    Change in average number cigarettes smoked per day by self report

  2. Percent days smoke-free

    Time frame: up to 8 weeks

    Percentage of smoke-free days by self report

  3. Average number of days to relapse

    Time frame: 2 weeks post quit date

    Relapse is defined as 7 consecutive days of smoking after quitting and will be measured using self-report or smartband detection. This will be assessed after their quit date.

  4. Treatment satisfaction assessed using the Mobile Application Rating Scale User version

    Time frame: up to 8 weeks

    This 20-item scale uses 5-point multiple choice ratings and has 6 subscales. Scores are reported as: 1) mean app quality, which is the mean score for the 4 subscales engagement, functionality, aesthetics, information quality; 2) mean of the app subjective quality subscale, and 3) mean of the perceived impact subscale. Higher scores indicate higher app quality, higher app subjective quality, and higher perceived impact. Mean scores range 1-5, with higher scores indicate higher app quality, higher app subjective quality, and higher perceived impact.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • American Lung Association

Registry information

Official study title

Evaluating Digital Health Interventions To Promote Smoking Cessation

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 1, 2023
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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