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Clinical Trials/NCT06088498
NCT06088498
Recruiting
Phase 2

Augmented Reality as an Adjunct to Quitline Counseling for Smoking Cessation

H. Lee Moffitt Cancer Center and Research Institute1 site in 1 country3,600 target enrollmentJune 11, 2024

Overview

Phase
Phase 2
Intervention
Quitline Services and Smartphone App
Conditions
Smoking
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Enrollment
3600
Locations
1
Primary Endpoint
Tobacco Abstinence (Aim 2)
Status
Recruiting
Last Updated
2 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 11, 2024
End Date
May 1, 2027
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: Quitline Services and 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.

Intervention: Quitline Services

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.

Intervention: Updating Existing Smartphone App

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.

Intervention: Quitline Services

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.

Intervention: Quitline Services and Smartphone App

Outcomes

Primary Outcomes

Tobacco Abstinence (Aim 2)

Time Frame: At 6 Months

Self-report of no combustible tobacco use in the past 7 days

System Usability Scale (Aim 1)

Time Frame: 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.

Secondary Outcomes

  • User Satisfaction (Aim 1)(At 1 Week)

Study Sites (1)

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