App for Reducing Cravings to Smoke

Augmented Reality as an Adjunct to Quitline Counseling for Smoking Cessation

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.

Study Overview

• Status: Recruiting
• Conditions: Smoking
• Intervention / Treatment: Behavioral: Quitline Services and Smartphone App; Behavioral: Quitline Services; Behavioral: Updating Existing Smartphone App

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 Type: Interventional
• Enrollment (Estimated): 3600
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Christine Vinci, PhD; Phone Number: 813-745-5421; Email: Christine.Vinci@moffitt.org

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
      • Sub-Investigator: Steve Sutton, PhD
      • Sub-Investigator: Kea Turner, PhD
      • Contact: Karen Brandon; Phone Number: 813-745-7691; Email: karen.brandon@moffitt.org
      • Principal Investigator: Christine Vinci, PhD
      • Sub-Investigator: Thomas Brandon, PhD
      • Sub-Investigator: Margaret Byrne, PhD
      • Sub-Investigator: Damon Vadrine, DRPH
      • Sub-Investigator: Lee Ritterbrand, PhD
      • Sub-Investigator: Kara Wiseman, PhD, MPH
      • Sub-Investigator: Katrina Vickerman, PhD
      • Contact: Marilyn Horta, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aim 1: Update an existing smartphone App; An existing study app will be updated to be engaging, user-friendly treatment tool, and verify user satisfaction.	Behavioral: Quitline Services and Smartphone App; In addition to quitline services, participants will download a study app that will allow them to track smoking urges and abstinence. After 48 hours of self-reported abstinence, those in the intervention group will be exposed to smoking extinction trials through the study smartphone app.
Experimental: Aim 2: Quit Line Only; 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.	Behavioral: Quitline Services; Quitline coaches use cognitive behavioral therapy, reinforcement, and principles of self-efficacy to promote effective behavior change. The quitline approach includes 5 key elements: setting a quit date, coping with triggers, effectively using medications, tobacco proofing, and social support. Individuals who enroll in the quitline's multi-call program receive phone calls and NRT.
Experimental: Aim 2:Quitline plus 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.	Behavioral: Quitline Services and Smartphone App; In addition to quitline services, participants will download a study app that will allow them to track smoking urges and abstinence. After 48 hours of self-reported abstinence, those in the intervention group will be exposed to smoking extinction trials through the study smartphone app.; Behavioral: Quitline Services; Quitline coaches use cognitive behavioral therapy, reinforcement, and principles of self-efficacy to promote effective behavior change. The quitline approach includes 5 key elements: setting a quit date, coping with triggers, effectively using medications, tobacco proofing, and social support. Individuals who enroll in the quitline's multi-call program receive phone calls and NRT.; Behavioral: Updating Existing Smartphone App; Participants will be asked to use a recently developed study smartphone application to reduce cravings to smoke for a 5-week period. Through the app, participants will be exposed to smoking extinction trials daily. Participants will be encouraged and reminded to complete 2-5 extinction sessions per day. Each session will present 3-8 cues, and each cue will be presented for 20-40 seconds (average amount of extinction per day will be about 10 minutes). Participants will be encouraged to conduct the extinction sessions when high cravings are expected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Usability Scale (Aim 1)	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.	At 1 Week
Tobacco Abstinence (Aim 2)	Self-report of no combustible tobacco use in the past 7 days	At 6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User Satisfaction (Aim 1)	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.	At 1 Week

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Christine Vinci, PhD, Moffitt Cancer Center

Publications and helpful links

General Publications

• Poudel R, Dougan SO, Yates H, Sawyer L, Martinez U, Brandon KO, Sutton SK, Vidrine DJ, Ritterband LM, Wiseman KP, Vickerman KA, Turner K, Byrne MM, Yang MJ, Horta M, Brandon TH, Vinci C. Using augmented reality to deliver cue exposure treatment for smoking cessation: App usability findings and protocol for a randomized controlled trial. Contemp Clin Trials. 2025 Mar;150:107827. doi: 10.1016/j.cct.2025.107827. Epub 2025 Jan 27.

Helpful Links

• Moffitt Cancer Center Clinical Trial Search

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Smoking
• Other Study ID Numbers: MCC-21980 Aim 2; R01DA055298 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No