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Utilizing Augmented Reality as an Adjunct for Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04101422
Recruitment Status : Completed
First Posted : September 24, 2019
Last Update Posted : January 9, 2023
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

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.

Condition or disease Intervention/treatment Phase
Smoking Behavioral: Augmented Reality 1 Behavioral: Augmented Reality 2 Behavioral: Augmented Reality 3 Behavioral: Augmented Reality 4 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Utilizing Augmented Reality as an Adjunct for Smoking Cessation; Development and Initial Validation
Actual Study Start Date : October 7, 2019
Actual Primary Completion Date : February 14, 2022
Actual Study Completion Date : February 14, 2022

Resource links provided by the National Library of Medicine


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 1: Cue Reactivity
142 study 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: 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: Testing AR Application
20 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.




Primary Outcome Measures :
  1. Urge to Smoke [ Time Frame: Pilot Testing and Laboratory Validation Sessions 1 and 2: Base line and post-cue presentation. Testing AR Application: Baseline to up to day 7 ]
    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).


Secondary Outcome Measures :
  1. Reality/Co-Existence [ Time Frame: Base line to post image presentation or post session ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04101422


Locations
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United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Christine Vinci, Ph.D. Moffitt Cancer Center
Principal Investigator: Thomas Brandon, Ph.D. Moffitt Cancer Center
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT04101422    
Other Study ID Numbers: MCC-20007
R34DA047598-03 ( U.S. NIH Grant/Contract )
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: January 9, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Quit Smoking
Augmented Reality
Smoking