Smoking
Conditions
Keywords
Quit Smoking, Augmented Reality, Smoking
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.
Interventions
BEHAVIORALAugmented 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).
BEHAVIORALAugmented 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.
BEHAVIORALAugmented 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.
BEHAVIORALAugmented 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.
Sponsors
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urge to Smoke - Pilot Testing | 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). |
| Urge to Smoke - AR Stimuli Session 1 | 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). |
| Urge to Smoke - AR Stimuli Session 2 | 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). |
| Urge to Smoke - Testing AR Application | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reality/Co-Existence - AR Stimuli Session 1 | 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). |
| Reality/Co-Existence - AR Stimuli Session 2 | 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). |
| Reality/Co-Existence - Pilot Testing | 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). |
Countries
United States
Participant flow
Pre-assignment details
The 17 participants in the Laboratory Validation of AR Stimuli Session 1: Cue Reactivity group were then randomized into either the Laboratory Validation of AR Stimuli Session 2: Extinction group or Control group.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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). | 11 |
| 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.
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. | 17 |
| Laboratory Validation of AR Stimuli Session 2: Extinction or Control 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.
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. | 126 |
| 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.
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. | 43 |
| Total | 197 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Did not download app | 0 | 0 | 0 | 17 |
| Overall Study | Did not use app on 4 or more occasions per protocol | 0 | 0 | 0 | 3 |
| Overall Study | Ineligible | 1 | 0 | 9 | 0 |
| Overall Study | Not attending to the stimuli | 0 | 0 | 4 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Pilot Testing of AR Application | Laboratory Validation of AR Stimuli Session 1: Cue Reactivity | Laboratory Validation of AR Stimuli Session 2: Extinction or Control | Testing AR Application | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 9 Participants | 1 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 17 Participants | 117 Participants | 42 Participants | 187 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 8 Participants | 5 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 16 Participants | 117 Participants | 38 Participants | 180 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 8 Participants | 45 Participants | 10 Participants | 67 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 7 Participants | 9 Participants | 78 Participants | 29 Participants | 123 Participants |
| Region of Enrollment United States | 11 participants | 17 participants | 126 participants | 43 participants | 197 participants |
| Sex: Female, Male Female | 4 Participants | 12 Participants | 61 Participants | 27 Participants | 104 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 65 Participants | 16 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 17 | 0 / 126 | 0 / 43 |
| other Total, other adverse events | 0 / 11 | 0 / 17 | 0 / 126 | 0 / 43 |
| serious Total, serious adverse events | 0 / 11 | 0 / 17 | 0 / 126 | 0 / 43 |
Outcome results
Primary
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).
Time frame: Post-cue presentation on Day 1, immediately following cue presentation
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Pilot Testing of AR Application | Urge to Smoke - AR Stimuli Session 1 | Smoking Related AR Images | 7.50 score on a scale |
| Pilot Testing of AR Application | Urge to Smoke - AR Stimuli Session 1 | Neutral Images | 3.33 score on a scale |
Primary
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).
Time frame: Post-cue presentation on Day 1, immediately following cue presentation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pilot Testing of AR Application | Urge to Smoke - AR Stimuli Session 2 | Extinction condition | 5.3 score on a scale | Standard Deviation 2.9 |
| Pilot Testing of AR Application | Urge to Smoke - AR Stimuli Session 2 | Control condition | 6.4 score on a scale | Standard Deviation 3.3 |
Primary
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).
Time frame: Post-cue presentation on Day 1, immediately following cue presentation
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Pilot Testing of AR Application | Urge to Smoke - Pilot Testing | Smoking Stimuli | 4.58 score on a scale |
| Pilot Testing of AR Application | Urge to Smoke - Pilot Testing | Neutral Stimuli | 1.42 score on a scale |
Primary
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).
Time frame: Up to Day 7 - Last Day of App Use, immediately following cue presentation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pilot Testing of AR Application | Urge to Smoke - Testing AR Application | 7.28 score on a scale |
Primary
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).
Time frame: Day 1 - First Day of App Use, immediately following cue presentation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pilot Testing of AR Application | Urge to Smoke - Testing AR Application | 7.61 score on a scale |
Secondary
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).
Time frame: Day 1, immediately following cue presentation
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Pilot Testing of AR Application | Reality/Co-Existence - AR Stimuli Session 1 | Realism | 7.83 score on a scale |
| Pilot Testing of AR Application | Reality/Co-Existence - AR Stimuli Session 1 | User Coexistence | 7.17 score on a scale |
| Pilot Testing of AR Application | Reality/Co-Existence - AR Stimuli Session 1 | Environmental Coexistence | 7.83 score on a scale |
Secondary
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).
Time frame: Day 1, immediately following cue presentation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pilot Testing of AR Application | Reality/Co-Existence - AR Stimuli Session 2 | Realism | 7.91 score on a scale | Standard Deviation 1.88 |
| Pilot Testing of AR Application | Reality/Co-Existence - AR Stimuli Session 2 | Enviromental Coexistence | 7.96 score on a scale | Standard Deviation 2.31 |
| Pilot Testing of AR Application | Reality/Co-Existence - AR Stimuli Session 2 | User Coexistence | 8.04 score on a scale | Standard Deviation 2.12 |
Secondary
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).
Time frame: Day 1, immediately following cue presentation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pilot Testing of AR Application | Reality/Co-Existence - Pilot Testing | Realistic | 6.49 score on a scale | Standard Deviation 3.11 |
| Pilot Testing of AR Application | Reality/Co-Existence - Pilot Testing | Environmental Coexistence | 6.93 score on a scale | Standard Deviation 3.04 |
| Pilot Testing of AR Application | Reality/Co-Existence - Pilot Testing | User Coexistence | 6.38 score on a scale | Standard Deviation 3.27 |