Utilizing Augmented Reality as an Adjunct for Smoking Cessation

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04101422
• Other study ID #: MCC-20007
• Secondary ID: R34DA047598-03
• Status: Completed
• Phase: N/A
• Start date: October 7, 2019
• Est. completion date: February 14, 2022

Study information

• Verified date: April 2023
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: February 14, 2022
• Est. primary completion date: February 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• 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).
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Post-cue presentation on Day 1, immediately following cue presentation
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).	Post-cue presentation on Day 1, immediately following cue presentation
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).	Post-cue presentation on Day 1, immediately following cue presentation
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).	Day 1 - First Day of App Use, immediately following cue presentation
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).	Up to Day 7 - Last Day of App Use, immediately following cue presentation
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).	Day 1, immediately following cue presentation
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).	Day 1, immediately following cue presentation
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).	Day 1, immediately following cue presentation