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Completed

NCT Number: NCT04101422

Utilizing Augmented Reality as an Adjunct for Smoking Cessation

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.

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Key information

Conditions

Smoking Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

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.

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.

Primary outcomes

  1. Urge to Smoke - Pilot Testing

    Time frame: Post-cue presentation on Day 1, immediately following cue presentation

    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).

  2. Urge to Smoke - AR Stimuli Session 1

    Time frame: Post-cue presentation on Day 1, immediately following cue presentation

    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).

  3. Urge to Smoke - AR Stimuli Session 2

    Time frame: Post-cue presentation on Day 1, immediately following cue presentation

    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).

  4. Urge to Smoke - Testing AR Application

    Time frame: Day 1 - First Day of App Use, immediately following cue presentation

    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).

  5. Urge to Smoke - Testing AR Application

    Time frame: Up to Day 7 - Last Day of App Use, immediately following cue presentation

    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 outcomes

  1. Reality/Co-Existence - Pilot Testing

    Time frame: Day 1, immediately following cue presentation

    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).

  2. Reality/Co-Existence - AR Stimuli Session 1

    Time frame: Day 1, immediately following cue presentation

    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).

  3. Reality/Co-Existence - AR Stimuli Session 2

    Time frame: Day 1, immediately following cue presentation

    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).

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 24, 2019
Registry last updated
May 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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