App for Reducing Cravings to Smoke

Sponsor

H. Lee Moffitt Cancer Center and Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT06088498

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

2,082

Enrollment

Location

Arms

26.7

Anticipated Duration (Months)

77.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking	Behavioral: Updating Existing Smartphone App Behavioral: Quitline Services Behavioral: Quitline Services and Smartphone App	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

2082 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Augmented Reality as an Adjunct to Quitline Counseling for Smoking Cessation

Actual Study Start Date :

Oct 9, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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: 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. 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.

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: 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.

Behavioral: Quitline Services

Outcome Measures

Primary Outcome Measures

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.
Tobacco Abstinence (Aim 2) [At 6 Months]
Self-report of no combustible tobacco use in the past 7 days

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moffitt Cancer Center	Tampa	Florida	United States	33612

Sponsors and Collaborators

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

Investigators

Principal Investigator: Christine Vinci, PhD, Moffitt Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Moffitt Cancer Center Clinical Trial Search

Publications

None provided.

Responsible Party:

H. Lee Moffitt Cancer Center and Research Institute

ClinicalTrials.gov Identifier:

NCT06088498

Other Study ID Numbers:

MCC-21980
R01DA055298

First Posted:

Oct 18, 2023

Last Update Posted:

Oct 18, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 18, 2023