Clinical trial NCT04101422: Utilizing Augmented Reality as an Adjunct for Smoking Cessation
Official title: Utilizing Augmented Reality as an Adjunct for Smoking Cessation; Development and Initial Validation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Quit Smoking
Augmented Reality
Smoking
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2019-09-24
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Urge to Smoke - Pilot Testing
timeFrame: Post-cue presentation on Day 1, immediately following cue presentation
measure: Urge to Smoke - AR Stimuli Session 1
timeFrame: Post-cue presentation on Day 1, immediately following cue presentation
measure: Urge to Smoke - AR Stimuli Session 2
timeFrame: Post-cue presentation on Day 1, immediately following cue presentation
measure: Urge to Smoke - Testing AR Application
timeFrame: Day 1 - First Day of App Use, immediately following cue presentation
measure: Urge to Smoke - Testing AR Application
timeFrame: Up to Day 7 - Last Day of App Use, immediately following cue presentation
Secondary outcomes:
measure: Reality/Co-Existence - Pilot Testing
timeFrame: Day 1, immediately following cue presentation
measure: Reality/Co-Existence - AR Stimuli Session 1
timeFrame: Day 1, immediately following cue presentation
measure: Reality/Co-Existence - AR Stimuli Session 2
timeFrame: Day 1, immediately following cue presentation
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Christine Vinci, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Moffitt Cancer Center
name: Thomas Brandon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brandon KO, Vinci C, Kleinjan M, Hernandez LM, Sawyer LE, Sutton SK, Brandon TH. Testing Augmented Reality for Eliciting Cue-Provoked Urges to Smoke: Toward Moving Cue-Exposure Into the Real World. Nicotine Tob Res. 2021 May 4;23(5):861-865. doi: 10.1093/ntr/ntaa259.
citation: Yang MJ, Brandon KO, Sutton SK, Kleinjan M, Sawyer LE, Brandon TH, Vinci C. Augmented reality as a novel approach for addiction treatment: development of a smoking cessation app. Ann Med. 2022 Dec;54(1):3096-3106. doi: 10.1080/07853890.2022.2140451.
citation: Yang MJ, Brandon KO, Sutton SK, Kleinjan M, Hernandez LM, Sawyer LE, Brandon TH, Vinci C. Augmented reality for extinction of cue-provoked urges to smoke: Proof of concept. Psychol Addict Behav. 2022 Dec;36(8):990-998. doi: 10.1037/adb0000868. Epub 2022 Jul 14.