App for Reducing Cravings to Smoke

Phase 2

Recruiting

• Conditions: Smoking
• Interventions: Behavioral: Quitline Services; Behavioral: Updating Existing Smartphone App; Behavioral: Quitline Services and Smartphone App

• Registration Number: NCT06088498
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

The overall goal of the study is to assess the efficacy of using cue exposure delivered via a smartphone application as an adjunct to Tobacco Quitline treatment to improve smoking abstinence.

Detailed Description

The aims of the study are: (1) to update a recently developed study-related smartphone application to reduce cravings to smoke to be an engaging, user-friendly treatment tool, and verify user satisfaction; and (2) to test in a randomized controlled trial the efficacy of the app as an adjunct to quitline smoking cessation treatment in improving smoking abstinence compared to the quitline only.

Study Timeline

• Study First Submitted: 2023-10-12
• Study First Submitted QC: 2023-10-12
• Study First Posted: 2023-10-18
• Study Start: 2024-06-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-20
• Primary Completion: 2027-05-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3600

Inclusion Criteria

• >18 years of age
• Daily smokers that have quit smoking within the past 3 months (Aim 1) or currently smoking ≥ 3 cigarettes per day for the past year (Aim 2)
• Functioning telephone number
• Owns a smart phone capable of supporting AR and willing to download the app
• Can speak, read and write in English

Exclusion Criteria

• Has another household member already enrolled in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aim 2:Quitline plus smartphone App	Quitline Services and Smartphone App	Participants randomized to this arm will receive usual care for smoking cessation via the quitline and a smartphone app that will allow them to track smoking urges and abstinence. After 48 hours of self-reported abstinence, they will be exposed to smoking extinction trials through the study smartphone app.
Aim 2: Quit Line Only	Quitline Services	Participants randomized to this arm will receive usual care for smoking cessation via the quitline and a smartphone app that will allow them to track smoking urges and abstinence.
Aim 2:Quitline plus smartphone App	Quitline Services	Participants randomized to this arm will receive usual care for smoking cessation via the quitline and a smartphone app that will allow them to track smoking urges and abstinence. After 48 hours of self-reported abstinence, they will be exposed to smoking extinction trials through the study smartphone app.
Aim 2:Quitline plus smartphone App	Updating Existing Smartphone App	Participants randomized to this arm will receive usual care for smoking cessation via the quitline and a smartphone app that will allow them to track smoking urges and abstinence. After 48 hours of self-reported abstinence, they will be exposed to smoking extinction trials through the study smartphone app.
Aim 1: Update an existing smartphone App	Quitline Services and Smartphone App	An existing study app will be updated to be engaging, user-friendly treatment tool, and verify user satisfaction.

Primary Outcome Measures

Name	Time	Method
Tobacco Abstinence (Aim 2)	At 6 Months	Self-report of no combustible tobacco use in the past 7 days
System Usability Scale (Aim 1)	At 1 Week	Participants' perception of usability and learnability of the app will be measured using 10 items on a 5-point Likert scale. Scores range from 0 to 100, with higher scores indicating better usability.

Secondary Outcome Measures

Name	Time	Method
User Satisfaction (Aim 1)	At 1 Week	One Likert scale item will capture participants' satisfaction with the app. The Likert scale is from 1 to 4, with higher score indicating greater satisfaction.

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States