Utilizing Augmented Reality as an Adjunct for Smoking Cessation

NCT04101422 | Completed Results

• 2 other identifiers: MCC-20007R34DA047598-03
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking

Keywords

Quit Smoking; Augmented Reality; Smoking

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Reality/Co-Existence - Pilot Testing

  Day 1, immediately following cue presentation

• Reality/Co-Existence - AR Stimuli Session 1

  Day 1, immediately following cue presentation

• Reality/Co-Existence - AR Stimuli Session 2

  Day 1, immediately following cue presentation

Study Arms (5)

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.

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.

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.

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.

Behavioral: Augmented Reality 3

Interventions

Augmented Reality 1 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).

Pilot Testing of AR Application

Augmented Reality 2 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 1: Cue Reactivity

Augmented Reality 3 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.

Testing AR Application

Augmented Reality 4 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.

Laboratory Validation of AR Stimuli Session 2: Extinction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Publications (3)

• 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.

  PMID: 33277653 RESULT

• 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.

  PMID: 36345961 DERIVED

• 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.

  PMID: 35834198 DERIVED

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Christine Vinci
• Organization: Moffitt Cancer Center

Christine.Vinci@moffitt.org

813-745-5421

Study Officials

• Christine Vinci, Ph.D.

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

• Thomas Brandon, Ph.D.

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 24, 2019
• Study Start: October 7, 2019
• Primary Completion: February 14, 2022
• Study Completion: February 14, 2022
• Last Updated: May 22, 2023
• Results First Posted: May 22, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)