Utilizing Augmented Reality as an Adjunct for Smoking Cessation

NCT ID: NCT04101422

Last Updated: 2023-05-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-07

Study Completion Date

2022-02-14

Brief Summary

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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.

Detailed Description

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Conditions

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Development of Augmented Reality (AR) Application

Investigators will collaborate with an AR software specialist to develop AR stimuli that are embedded within a basic digital application.

Group Type NO_INTERVENTION

No interventions assigned to this group

Pilot Testing of AR Application

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.

Group Type EXPERIMENTAL

Augmented Reality 1

Intervention Type BEHAVIORAL

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).

Laboratory Validation of AR Stimuli Session 1: Cue Reactivity

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.

Group Type EXPERIMENTAL

Augmented Reality 2

Intervention Type BEHAVIORAL

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.

Laboratory Validation of AR Stimuli Session 2: Extinction

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.

Group Type EXPERIMENTAL

Augmented Reality 4

Intervention Type BEHAVIORAL

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.

Testing AR Application

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.

Group Type EXPERIMENTAL

Augmented Reality 3

Intervention Type BEHAVIORAL

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.

Interventions

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Augmented Reality 1

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).

Intervention Type BEHAVIORAL

Augmented Reality 2

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.

Intervention Type BEHAVIORAL

Augmented Reality 3

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.

Intervention Type BEHAVIORAL

Augmented Reality 4

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine Vinci, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Thomas Brandon, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

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Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 33277653 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36345961 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35834198 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R34DA047598-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MCC-20007

Identifier Type: -

Identifier Source: org_study_id

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