App for Reducing Cravings to Smoke

Smoking Clinical Trial

Official title:

Augmented Reality as an Adjunct to Quitline Counseling for Smoking Cessation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06088498
• Other study ID #: MCC-21980
• Secondary ID: R01DA055298
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Christine Vinci, PhD
• Phone: 813-745-5421
• Email: Christine.Vinci[@]moffitt.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2082
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• Updating Existing Smartphone App
Participants will be asked to use a recently developed study smartphone application to reduce cravings to smoke for a 1-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 3-10 cues, and each cue will be presented for 30-60 seconds (average amount of extinction per day will be about 17 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.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Tobacco Abstinence (Aim 2)	Self-report of no combustible tobacco use in the past 7 days	At 6 Months
Secondary	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

External Links

•   Moffitt Cancer Center Clinical Trial Search