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Clinical Trial 20007

Cancer Type: Healthy Subjects
Study Type: Prevention
NCT#: NCT04101422

Phase: N/A
Principal Investigator: Vinci, Christine

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Study Title

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


The purpose of the study is to create stop-smoking treatments using Augmented Reality (AR).


Aim 1. Develop and pilot test the smoking and neutral AR stimuli. Working with AR software specialists, we will develop 6 smoking and 6 neutral AR stimuli imbedded within a digital application. We will then pilot test these stimuli on a set of smokers (N = 10), and modify based on their feedback. Aim 2. Validate the AR stimuli for eliciting cue-reactivity and extinction in the laboratory. Using a 2x2 factorial design, participants (N = 142) will receive all four cue stimuli sets (AR smoking; AR neutral; in vivo smoking; in vivo neutral) to assess the magnitude of AR smoking cue-reactivity. In a second session, participants will be repeatedly exposed to the AR smoking or AR neutral cues to assess extinction of urge. Hypothesis 1 (cue-reactivity): AR smoking stimuli will produce greater urge to smoke than AR neutral stimuli, with effect sizes comparable to both the existing literature and in vivo cues from this study, thus validating AR as a technique for producing cue-reactivity. Hypothesis 2 (extinction): Urge to smoke (primary outcome) will significantly decrease following a series of AR smoking stimulus exposure trials; latency to smoke (secondary outcome) following the last trial will be longer in the extinction group than the control group. Exploratory Tests: We will test theory-based variables as moderating (e.g., sex, nicotine dependence, cue-reactivity) and mediating variables (AR co-existence/immersion in the environment) to further elucidate boundary conditions and mechanisms of action Aim 3. Translate AR app into functional intervention adjuvant. Update the app for clinical use and conduct small-scale field tests with smokers (N = 20) in natural settings. This project is expected to validate AR as a strategy for conducting extinction trials that form the basis of cue-exposure therapy and set the stage for a randomized controlled trial to test AR as a component of a more comprehensive smoking cessation intervention.




Inclusion Criteria

  • Currently smoking 3 or more cigarettes per day for the past year
  • Breath carbon monoxide (CO) level ≥ 5 ppm
  • Motivated to quit smoking
  • Aim 1 & 2: 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

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