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Aim 1: App for Reducing Cravings to Smoke

Aim 1: Augmented Reality as an Adjunct to Quitline Counseling for Smoking Cessation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06923033
Enrollment
14
Registered
2025-04-11
Start date
2023-10-09
Completion date
2023-11-02
Last updated
2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking

Brief summary

The aim of this study is 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

Interventions

BEHAVIORALSmartphone App

Participants will download a study app that will allow them to track smoking urges and abstinence. Access to augmented reality will become available after 48 hours of self-reported abstinence.

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
System Usability Scale (Aim 1)At 1 weekParticipants' 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

MeasureTime frameDescription
User Satisfaction (Aim 1)At 1 weekOne Likert scale item will capture participants' satisfaction with the app. The Likert scale is from 1 to 4, with higher score indicating greater satisfaction.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. Smartphone App: Participants will download a study app that will allow them to track smoking urges and abstinence. Access to augmented reality will become available after 48 hours of self-reported abstinence.
10
Total10

Baseline characteristics

CharacteristicAim 1: Update an Existing Smartphone App
Age, Continuous37.9 years
STANDARD_DEVIATION 14.2
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
4 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
6 Participants
Region of Enrollment
United States
10 participants
Sex: Female, Male
Female
4 Participants
Sex: Female, Male
Male
6 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

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.

Time frame: At 1 week

ArmMeasureValue (MEAN)Dispersion
Aim 1: Update an Existing Smartphone AppSystem Usability Scale (Aim 1)70.3 score on a scaleStandard Deviation 20.1
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.

Time frame: At 1 week

ArmMeasureValue (MEAN)Dispersion
Aim 1: Update an Existing Smartphone AppUser Satisfaction (Aim 1)3.4 score on a scaleStandard Deviation 0.6

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026