Utilizing Augmented Reality as an Adjunct for Smoking Cessation

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Behavioral: Augmented Reality 1; Behavioral: Augmented Reality 2; Behavioral: Augmented Reality 4; Behavioral: Augmented Reality 3

• Study Type: Interventional
• Enrollment (Actual): 197
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Behavioral: 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).
Experimental: 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.	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.
Experimental: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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).	Up to Day 7 - Last Day of App Use, immediately following cue presentation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	Day 1, immediately following cue presentation

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Christine Vinci, Ph.D., Moffitt Cancer Center; Principal Investigator: Thomas Brandon, Ph.D., Moffitt Cancer Center

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2019
• Primary Completion (Actual): February 14, 2022
• Study Completion (Actual): February 14, 2022

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Smoking; Augmented Reality; Quit Smoking
• Other Study ID Numbers: MCC-20007; R34DA047598-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No