App for Reducing Cravings to Smoke

NCT ID: NCT06088498

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

3600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-11

Study Completion Date

2027-05-01

Brief Summary

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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

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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.

Conditions

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
The statistician is masked

Study Groups

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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.

Group Type EXPERIMENTAL

Quitline Services and Smartphone App

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Quitline Services

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Updating Existing Smartphone App

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine Vinci, PhD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

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Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Christine Vinci, PhD

Role: CONTACT

Phone: 813-745-5421

Email: [email protected]

Facility Contacts

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Karen Brandon

Role: primary

Marilyn Horta, PhD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 39880329 (View on PubMed)

Related Links

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Other Identifiers

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R01DA055298

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MCC-21980 Aim 2

Identifier Type: -

Identifier Source: org_study_id