SmokingPhase 2NCT06088498
App for Reducing Cravings to Smoke
A Phase 2 study testing Updating Existing Smartphone App, Quitline Services and Quitline Services and Smartphone App in people with Smoking, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Updating Existing Smartphone App, Quitline Services and Quitline Services and Smartphone App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,051 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2024to 1 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- Has another household member already enrolled in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Augmented Reality as an Adjunct to Quitline Counseling for Smoking Cessation
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.
Read the 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.
- Conditions
- Smoking
- Being tested
- Updating Existing Smartphone App, Quitline Services, Quitline Services and Smartphone App
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Updating Existing Smartphone AppBehavioural
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 ServicesBehavioural
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 AppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Aim 1: Update an existing smartphone App | Experimental | An existing study app will be updated to be engaging, user-friendly treatment tool, and verify user satisfaction. Receives: Behavioral: Quitline Services and Smartphone App |
| Aim 2: Quit Line Only | Experimental | 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. Receives: Behavioral: Quitline Services |
| Aim 2:Quitline plus smartphone App | Experimental | 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. Receives: Behavioral: Updating Existing Smartphone App; Behavioral: Quitline Services; Behavioral: Quitline Services and Smartphone App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 1 Week
Tobacco Abstinence (Aim 2)
Self-report of no combustible tobacco use in the past 7 days
Measured: At 6 Months
Secondary outcomes (1)
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.
Measured: At 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start11 Jun 2024
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,051 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Christine Vinci, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088498
- Sponsor's protocol ID
- MCC-21980 Aim 2
- Other IDs
- R01DA055298
- Status last verified
- Sep 2026
- First submitted
- 12 Oct 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39880329
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Reality as an Adjunct to Quitline Counseling for Smoking Cessation
- ClinicalTrials.gov ID
- NCT06088498
- Acronym / sponsor ID
- MCC-21980 Aim 2
- Conditions
- Smoking
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,051 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aim 1: Update an existing smartphone App | Experimental | Behavioral: Quitline Services and Smartphone AppAn existing study app will be updated to be engaging, user-friendly treatment tool, and verify user satisfaction. |
| Aim 2: Quit Line Only | Experimental | Behavioral: Quitline ServicesParticipants 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. |
| Aim 2:Quitline plus smartphone App | Experimental | Behavioral: Updating Existing Smartphone App, Behavioral: Quitline Services, Behavioral: Quitline Services and Smartphone AppParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >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
Key exclusion criteria (1 listed)
- Has another household member already enrolled in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Updating Existing Smartphone AppParticipants 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. | Behavioural | Aim 2:Quitline plus smartphone App |
| Quitline ServicesQuitline 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. | Behavioural | Aim 2: Quit Line Only, Aim 2:Quitline plus smartphone App |
| Quitline Services and Smartphone AppIn 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. | Behavioural | Aim 1: Update an existing smartphone App, Aim 2:Quitline plus smartphone App |
Primary outcome
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.
Tobacco Abstinence (Aim 2)
Time frame: At 6 Months
Self-report of no combustible tobacco use in the past 7 days
1 secondary outcome
User Satisfaction (Aim 1)
Time frame: At 1 Week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Derived from this study: PubMed 39880329Poudel 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.
- Individual participant dataSharing planned: Undecided
Related trials for Smoking
Active, not recruiting
An Interactive Smartphone Application to Motivate Smokers to Quit
Smoking Cessation, Smoking Behaviors
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Vinci, PhD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Updating Existing Smartphone App, Quitline Services and Quitline Services and Smartphone App in people with Smoking, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (Aim 1) (time frame: At 1 Week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06088498, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.