Recruiting
Phase 2

Cue Exposure with Tobacco Quitline

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT06088498

Conditions

Smoking

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Updating Existing Smartphone App

Quitline Services

Quitline Services and Smartphone App

Study Details

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.

Conditions

Smoking

Study ID

NCT06088498

Start date

Jun 11, 2024

Status verified date

Feb, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

3600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

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.

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.

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.

Primary outcome measure

  • System Usability Scale (Aim 1) [ Time Frame: At 1 Week ]
  • Tobacco Abstinence (Aim 2) [ Time Frame: At 6 Months ]

Central Contacts and Locations

Central contacts

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Principal Investigator:

Christine Vinci, PhD

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2026-02-09.