SmokingNCT04101422

Utilizing Augmented Reality as an Adjunct for Smoking Cessation

A study testing Augmented Reality 1, Augmented Reality 2 and Augmented Reality 3 in people with Smoking, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to develop an preliminary test a tobacco smoking-related augmented reality (AR) paradigm for eventual development as an adjunctive tobacco cessation intervention. 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?: Augmented Reality 1, Augmented Reality 2 and Augmented Reality 3
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 197 participants
Where: 1 siteUnited States
Study dates: 7 Oct 2019to 14 Feb 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Currently smoking ≥ 3 cigarettes per day for the past year
Breath carbon monoxide (CO) level ≥ 5 ppm
Motivated to quit smoking
Aim 1 \& 2 Only: Valid home address in the Tampa Bay area
Functioning telephone number
Can speak, read, and write in English
Aim 3: Must have a smartphone that participant is willing to use during the study
Aim 3: Motivated to quit smoking within the next month

Who cannot join

Regular use (e.g., no more than 1/3 of month) of other tobacco products (cigars)
Household member already enrolled in the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Moffitt Cancer Center
Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Utilizing Augmented Reality as an Adjunct for Smoking Cessation; Development and Initial Validation

The purpose of the study is to develop an preliminary test a tobacco smoking-related augmented reality (AR) paradigm for eventual development as an adjunctive tobacco cessation intervention.

Conditions: Smoking
Being tested: Augmented Reality 1, Augmented Reality 2, Augmented Reality 3, Augmented Reality 4
Keywords: Quit Smoking, Augmented Reality, Smoking
Medical subject headings: Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Augmented Reality 1Behavioural
Participants will use an Augmented Reality (AR) application on smart phones. The AR application will create simulated examples of AR stimuli (cigarettes, lighters, ashtrays) and non-smoking related stimuli (pens, notebook, eraser).
Augmented Reality 2Behavioural
Participants will use an Augmented Reality (AR) application on smart phones. The AR application will create simulated examples of smoking related AR stimuli (cigarettes, lighters, ashtrays) as well as non-smoking images (pens, notebook, etc.). They will also be presented with real smoking (e.g., ashtray) and non-smoking (e.g., pencil) items. Their urge to smoke rating following each presentation will be compared for AR images vs. vivo items, and smoking-related vs. non-smoking related.
Augmented Reality 3Behavioural
Participants will use an Augmented Reality )AR) application on smart phones in locations and situations where they typically smoke. the application will create simulated examples of AR stimuli (cigarettes, lighters, ashtrays). Participants will have a goal of using application at least 5 times per day for 7 days. Usage and rating data will be collected in real-time.
Augmented Reality 4Behavioural
Participants will use an Augmented Reality (AR) application on smart phones. The AR application will create simulated examples of AR stimuli (cigarettes, lighters, ashtrays) as well as non-smoking images (pens, notebook, etc.) Their urge to smoke rating following each presentation will be compared from baseline urge to smoke. The post-test urge to smoke will be compared between control group and extinction group.

Study groups in NCT04101422
Study group	Role	What they receive
Development of Augmented Reality (AR) Application	No intervention	Investigators will collaborate with an AR software specialist to develop AR stimuli that are embedded within a basic digital application.
Pilot Testing of AR Application	Experimental	AR stimuli (smoking, e.g, cigarette, ashtray, lighter; and non-smoking, e.g., pen, notebook, eraser) will be piloted on a small group of smokers to receive feedback and modify as needed. Participants will answer questions from a 10 point Likert scale that will asses urge from 1 (absolutely no urge to smoke) to 10 (strongest urge to smoke) and reality/co-existence (how realistic the item looks, and it's integration into the environment), from 1 (Not at all) to 10 (Very Much). Participants will then be asked additional open-ended questions about the quality of the images following the ratings of the images. Receives: Behavioral: Augmented Reality 1
Laboratory Validation of AR Stimuli Session 1: Cue Reactivity	Experimental	Participants will attend 1st lab based session that will test cue-reactivity. Participant will be randomized to view either AR images, or in vivo items first. Order of presentation of items will also be randomized within the type (AR or in vivo).Session 1 should last under 1 hour. Receives: Behavioral: Augmented Reality 2
Laboratory Validation of AR Stimuli Session 2: Extinction	Experimental	Participants will be randomized into either the extinction or control group. 28 trials of AR cues will be presented for each group. Both groups will receive the same neutral cue in Trial 1 (to establish baseline urge) and the same smoking cue in Trial 2 (for pre-test cue-reactivity). The extinction group will receive smoking cues for trials 3-26, whereas the control group will receive neutral cues. Both groups will receive matched smoking cues for trial (27) followed by matched neutral cues for the final trial (28), for post-test cuereactivity. Each cue will be presented for 1 minute and will be shown 4 times in trials 3-26. Following each cue, participants will complete the single-item measure of urge. Following the final trial (28) for both groups, participants will be presented with one of their own cigarettes and asked to take at least one puff. Latency to smoke will later be determined using time stamps on the video recording. Session 2 is expected to last 1.25 hours. Receives: Behavioral: Augmented Reality 4
Testing AR Application	Experimental	Participants will be instructed to use the AR app that presents smoking-related stimuli (cigarette, ashtray, lighter) in locations/situations where they typically smoke with the goal of at least 5 uses per day for 7 days. Usage and rating data will be collected in real-time. Participants will also be asked to rate their urge to smoke on the smartphone app at selected times. Participants will complete a telephone interview to provide additional feedback on the app, answer questions related to smoking behavior, and receive an in-person interview on their perceptions of the app as a potential cessation tool. Participants will use the smart phone application for 7 days. Receives: Behavioral: Augmented Reality 3

What is being measured

The primary outcome is the main question the study is designed to answer.

Urge to Smoke - Pilot Testing
Participants will rate their urge to smoke on a 10-point Likert scale from 1 (absolutely no urge to smoke) to 10 (strongest urge to smoke).
Measured: Post-cue presentation on Day 1, immediately following cue presentation
Urge to Smoke - AR Stimuli Session 1
Participants will rate their urge to smoke on a 10-point Likert scale from 1 (absolutely no urge to smoke) to 10 (strongest urge to smoke).
Measured: Post-cue presentation on Day 1, immediately following cue presentation
Urge to Smoke - AR Stimuli Session 2
Participants will rate their urge to smoke on a 10-point Likert scale from 1 (absolutely no urge to smoke) to 10 (strongest urge to smoke).
Measured: Post-cue presentation on Day 1, immediately following cue presentation
Urge to Smoke - Testing AR Application
Participants will rate their urge to smoke on a 10-point Likert scale from 1 (absolutely no urge to smoke) to 10 (strongest urge to smoke).
Measured: Day 1 - First Day of App Use, immediately following cue presentation
Urge to Smoke - Testing AR Application
Participants will rate their urge to smoke on a 10-point Likert scale from 1 (absolutely no urge to smoke) to 10 (strongest urge to smoke).
Measured: Up to Day 7 - Last Day of App Use, immediately following cue presentation

Secondary outcomes (3)

Reality/Co-Existence - Pilot Testing
Three items will be used to assess the quality of the AR experience. Reality (How real did the object seem to you?) Environment Co-Existence (How well did the the object appear to be part of the scene?) and User Co-Existence (How much did you feel the object was right there in front of you?). These 3 items will be assessed using a 10 point Likert Scale from from 1 (Not at all) to 10 (Very much).
Measured: Day 1, immediately following cue presentation
Reality/Co-Existence - AR Stimuli Session 1
Three items will be used to assess the quality of the AR experience. Reality (How real did the object seem to you?) Environment Co-Existence (How well did the the object appear to be part of the scene?) and User Co-Existence (How much did you feel the object was right there in front of you?). These 3 items will be assessed using a 10 point Likert Scale from from 1 (Not at all) to 10 (Very much).
Measured: Day 1, immediately following cue presentation
Reality/Co-Existence - AR Stimuli Session 2
Three items will be used to assess the quality of the AR experience. Reality (How real did the object seem to you?) Environment Co-Existence (How well did the the object appear to be part of the scene?) and User Co-Existence (How much did you feel the object was right there in front of you?). These 3 items will be assessed using a 10 point Likert Scale from from 1 (Not at all) to 10 (Very much).
Measured: Day 1, immediately following cue presentation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Oct 201914 Feb 2022

First posted24 Sep 2019
Study start7 Oct 2019
Primary completion14 Feb 2022
Study completion14 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)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 N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 197 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04101422
Sponsor's protocol ID: MCC-20007
Other IDs: R34DA047598-03
Status last verified: Apr 2023
First submitted: 23 Sep 2019
Last updated: 22 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Brandon KO, Vinci C, Kleinjan M, Hernandez LM, Sawyer LE, Sutton SK, Brandon TH. Testing Augmented Reality for Eliciting Cue-Provoked Urges to Smoke: Toward Moving Cue-Exposure Into the Real World. Nicotine Tob Res. 2021 May 4;23(5):861-865. doi: 10.1093/ntr/ntaa259.
PubMed 33277653
Yang MJ, Brandon KO, Sutton SK, Kleinjan M, Sawyer LE, Brandon TH, Vinci C. Augmented reality as a novel approach for addiction treatment: development of a smoking cessation app. Ann Med. 2022 Dec;54(1):3096-3106. doi: 10.1080/07853890.2022.2140451.
PubMed 36345961
Yang MJ, Brandon KO, Sutton SK, Kleinjan M, Hernandez LM, Sawyer LE, Brandon TH, Vinci C. Augmented reality for extinction of cue-provoked urges to smoke: Proof of concept. Psychol Addict Behav. 2022 Dec;36(8):990-998. doi: 10.1037/adb0000868. Epub 2022 Jul 14.
PubMed 35834198

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Smoking trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Utilizing Augmented Reality as an Adjunct for Smoking Cessation; Development and Initial Validation
ClinicalTrials.gov ID: NCT04101422
Acronym / sponsor ID: MCC-20007
Conditions: Smoking
Keywords: Quit Smoking, Augmented Reality, Smoking
Study type: Interventional
Recruitment status: Completed
Enrolment: 197 participants (actual)
Lead sponsor: H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
Study start: 7 Oct 2019 (actual)
Primary completion: 14 Feb 2022 (actual)
Study completion: 14 Feb 2022 (actual)
First posted: 24 Sep 2019 (actual)
Results: Posted 22 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to develop an preliminary test a tobacco smoking-related augmented reality (AR) paradigm for eventual development as an adjunctive tobacco cessation intervention.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 5

Arm	Type	Receives
Development of Augmented Reality (AR) Application	No intervention	–Investigators will collaborate with an AR software specialist to develop AR stimuli that are embedded within a basic digital application.
Pilot Testing of AR Application	Experimental	Behavioral: Augmented Reality 1AR stimuli (smoking, e.g, cigarette, ashtray, lighter; and non-smoking, e.g., pen, notebook, eraser) will be piloted on a small group of smokers to receive feedback and modify as needed. Participants will answer questions from a 10 point Likert scale that will asses urge from 1 (absolutely no urge to smoke) to 10 (strongest urge to smoke) and reality/co-existence (how realistic the item looks, and it's integration into the environment), from 1 (Not at all) to 10 (Very Much). Participants will then be asked additional open-ended questions about the quality of the images following the ratings of the images.
Laboratory Validation of AR Stimuli Session 1: Cue Reactivity	Experimental	Behavioral: Augmented Reality 2Participants will attend 1st lab based session that will test cue-reactivity. Participant will be randomized to view either AR images, or in vivo items first. Order of presentation of items will also be randomized within the type (AR or in vivo).Session 1 should last under 1 hour.
Laboratory Validation of AR Stimuli Session 2: Extinction	Experimental	Behavioral: Augmented Reality 4Participants will be randomized into either the extinction or control group. 28 trials of AR cues will be presented for each group. Both groups will receive the same neutral cue in Trial 1 (to establish baseline urge) and the same smoking cue in Trial 2 (for pre-test cue-reactivity). The extinction group will receive smoking cues for trials 3-26, whereas the control group will receive neutral cues. Both groups will receive matched smoking cues for trial (27) followed by matched neutral cues for the final trial (28), for post-test cuereactivity. Each cue will be presented for 1 minute and will be shown 4 times in trials 3-26. Following each cue, participants will complete the single-item measure of urge. Following the final trial (28) for both groups, participants will be presented with one of their own cigarettes and asked to take at least one puff. Latency to smoke will later be determined using time stamps on the video recording. Session 2 is expected to last 1.25 hours.
Testing AR Application	Experimental	Behavioral: Augmented Reality 3Participants will be instructed to use the AR app that presents smoking-related stimuli (cigarette, ashtray, lighter) in locations/situations where they typically smoke with the goal of at least 5 uses per day for 7 days. Usage and rating data will be collected in real-time. Participants will also be asked to rate their urge to smoke on the smartphone app at selected times. Participants will complete a telephone interview to provide additional feedback on the app, answer questions related to smoking behavior, and receive an in-person interview on their perceptions of the app as a potential cessation tool. Participants will use the smart phone application for 7 days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Currently smoking ≥ 3 cigarettes per day for the past year
Breath carbon monoxide (CO) level ≥ 5 ppm
Motivated to quit smoking
Aim 1 \& 2 Only: Valid home address in the Tampa Bay area
Functioning telephone number

Key exclusion criteria (2 listed)

Regular use (e.g., no more than 1/3 of month) of other tobacco products (cigars)
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
Augmented Reality 1Participants will use an Augmented Reality (AR) application on smart phones. The AR application will create simulated examples of AR stimuli (cigarettes, lighters, ashtrays) and non-smoking related stimuli (pens, notebook, eraser).	Behavioural	Pilot Testing of AR Application
Augmented Reality 2Participants will use an Augmented Reality (AR) application on smart phones. The AR application will create simulated examples of smoking related AR stimuli (cigarettes, lighters, ashtrays) as well as non-smoking images (pens, notebook, etc.). They will also be presented with real smoking (e.g., ashtray) and non-smoking (e.g., pencil) items. Their urge to smoke rating following each presentation will be compared for AR images vs. vivo items, and smoking-related vs. non-smoking related.	Behavioural	Laboratory Validation of AR Stimuli Session 1: Cue Reactivity
Augmented Reality 3Participants will use an Augmented Reality )AR) application on smart phones in locations and situations where they typically smoke. the application will create simulated examples of AR stimuli (cigarettes, lighters, ashtrays). Participants will have a goal of using application at least 5 times per day for 7 days. Usage and rating data will be collected in real-time.	Behavioural	Testing AR Application
Augmented Reality 4Participants will use an Augmented Reality (AR) application on smart phones. The AR application will create simulated examples of AR stimuli (cigarettes, lighters, ashtrays) as well as non-smoking images (pens, notebook, etc.) Their urge to smoke rating following each presentation will be compared from baseline urge to smoke. The post-test urge to smoke will be compared between control group and extinction group.	Behavioural	Laboratory Validation of AR Stimuli Session 2: Extinction

Primary outcome

Urge to Smoke - Pilot Testing
Time frame: Post-cue presentation on Day 1, immediately following cue presentation
Participants will rate their urge to smoke on a 10-point Likert scale from 1 (absolutely no urge to smoke) to 10 (strongest urge to smoke).
Urge to Smoke - AR Stimuli Session 1
Time frame: Post-cue presentation on Day 1, immediately following cue presentation
Participants will rate their urge to smoke on a 10-point Likert scale from 1 (absolutely no urge to smoke) to 10 (strongest urge to smoke).
Urge to Smoke - AR Stimuli Session 2
Time frame: Post-cue presentation on Day 1, immediately following cue presentation
Participants will rate their urge to smoke on a 10-point Likert scale from 1 (absolutely no urge to smoke) to 10 (strongest urge to smoke).
Urge to Smoke - Testing AR Application
Time frame: Day 1 - First Day of App Use, immediately following cue presentation
Participants will rate their urge to smoke on a 10-point Likert scale from 1 (absolutely no urge to smoke) to 10 (strongest urge to smoke).
Urge to Smoke - Testing AR Application
Time frame: Up to Day 7 - Last Day of App Use, immediately following cue presentation
Participants will rate their urge to smoke on a 10-point Likert scale from 1 (absolutely no urge to smoke) to 10 (strongest urge to smoke).

3 secondary outcomes

Reality/Co-Existence - Pilot Testing
Time frame: Day 1, immediately following cue presentation
Reality/Co-Existence - AR Stimuli Session 1
Time frame: Day 1, immediately following cue presentation
Reality/Co-Existence - AR Stimuli Session 2
Time frame: Day 1, immediately following cue presentation

Results and safety

Results posted to the registry on 22 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pilot Testing of AR Application	11	10
Laboratory Validation of AR Stimuli Session 1: Cue Reactivity	17	17
Laboratory Validation of AR Stimuli Session 2: Extinction or Control	126	112
Testing AR Application	43	23

Primary outcome: Urge to Smoke - Pilot Testing

Time frame: Post-cue presentation on Day 1, immediately following cue presentation. Median (Full Range). Unit: score on a scale

Measure	Pilot Testing of AR Application n = 10
Smoking Stimuli	4.58 (1 to 10)
Neutral Stimuli	1.42 (1 to 10)

Primary outcome: Urge to Smoke - AR Stimuli Session 1

Time frame: Post-cue presentation on Day 1, immediately following cue presentation. Median (Full Range). Unit: score on a scale

Measure	Laboratory Validation of AR Stimuli Session 1: Cue Reactivity n = 17
Smoking Related AR Images	7.50 (1 to 10)
Neutral Images	3.33 (1 to 10)

Primary outcome: Urge to Smoke - AR Stimuli Session 2

Time frame: Post-cue presentation on Day 1, immediately following cue presentation. Mean (Standard Deviation). Unit: score on a scale

Measure	Laboratory Validation of AR Stimuli Session 2: Extinction n = 129
Extinction condition	5.3 (2.9)
Control condition	6.4 (3.3)

Primary outcome: Urge to Smoke - Testing AR Application

Time frame: Day 1 - First Day of App Use, immediately following cue presentation. Median (Full Range). Unit: score on a scale

Measure	Testing AR Application n = 23
Value	7.61 (1 to 10)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the first day of being on study until participant was off study, an average of 5 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pilot Testing of AR Application	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Laboratory Validation of AR Stimuli Session 1: Cue Reactivity	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Laboratory Validation of AR Stimuli Session 2: Extinction	0 of 126 (0%)	0 of 126 (0%)	0 of 126
Testing AR Application	0 of 43 (0%)	0 of 43 (0%)	0 of 43

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 33277653Brandon KO, Vinci C, Kleinjan M, Hernandez LM, Sawyer LE, Sutton SK, Brandon TH. Testing Augmented Reality for Eliciting Cue-Provoked Urges to Smoke: Toward Moving Cue-Exposure Into the Real World. Nicotine Tob Res. 2021 May 4;23(5):861-865. doi: 10.1093/ntr/ntaa259.
Derived from this study: PubMed 36345961Yang MJ, Brandon KO, Sutton SK, Kleinjan M, Sawyer LE, Brandon TH, Vinci C. Augmented reality as a novel approach for addiction treatment: development of a smoking cessation app. Ann Med. 2022 Dec;54(1):3096-3106. doi: 10.1080/07853890.2022.2140451.
Derived from this study: PubMed 35834198Yang MJ, Brandon KO, Sutton SK, Kleinjan M, Hernandez LM, Sawyer LE, Brandon TH, Vinci C. Augmented reality for extinction of cue-provoked urges to smoke: Proof of concept. Psychol Addict Behav. 2022 Dec;36(8):990-998. doi: 10.1037/adb0000868. Epub 2022 Jul 14.
Individual participant dataSharing planned: No

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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, Ph.D. principal investigator

Moffitt Cancer Center

Thomas Brandon, Ph.D. 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 study testing Augmented Reality 1, Augmented Reality 2 and Augmented Reality 3 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 8 inclusion and 2 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: finished, as of the sponsor's last update on 22 May 2023. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Urge to Smoke - Pilot Testing (time frame: Post-cue presentation on Day 1, immediately following cue presentation). The study lists 5 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 NCT04101422, which also lists 3 linked publications.

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 22 May 2023.