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Augmented Reality 1 for Smoking
N/A
Waitlist Available
Led By Christine Vinci, Ph.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 7 - last day of app use, immediately following cue presentation
Awards & highlights
Study Summary
This trial is testing a new way to help people quit smoking using augmented reality.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 7 - last day of app use, immediately following cue presentation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 7 - last day of app use, immediately following cue presentation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Urge to Smoke - AR Stimuli Session 1
Urge to Smoke - AR Stimuli Session 2
Urge to Smoke - Pilot Testing
+1 moreSecondary outcome measures
Reality/Co-Existence - AR Stimuli Session 1
Reality/Co-Existence - AR Stimuli Session 2
Reality/Co-Existence - Pilot Testing
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Testing AR ApplicationExperimental Treatment1 Intervention
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.
Group II: Pilot Testing of AR ApplicationExperimental Treatment1 Intervention
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.
Group III: Laboratory Validation of AR Stimuli Session 2: ExtinctionExperimental Treatment1 Intervention
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.
Group IV: Laboratory Validation of AR Stimuli Session 1: Cue ReactivityExperimental Treatment1 Intervention
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.
Group V: Development of Augmented Reality (AR) ApplicationActive Control1 Intervention
Investigators will collaborate with an AR software specialist to develop AR stimuli that are embedded within a basic digital application.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Augmented Reality 4
2019
N/A
~200
Augmented Reality 3
2019
N/A
~200
Augmented Reality 1
2019
N/A
~200
Augmented Reality 2
2019
N/A
~200
Find a Location
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,534 Total Patients Enrolled
66 Trials studying Smoking
22,424 Patients Enrolled for Smoking
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,653 Total Patients Enrolled
35 Trials studying Smoking
14,018 Patients Enrolled for Smoking
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
543 Previous Clinical Trials
135,285 Total Patients Enrolled
3 Trials studying Smoking
2,156 Patients Enrolled for Smoking
Frequently Asked Questions
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