Stanford Tobacco Treatment Services - Virtual Reality Treatment for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

Stanford Tobacco Treatment Services - Virtual Reality Treatment for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05220254
• Other study ID #: IRB-60253
• Secondary ID: P30CA124435
• Status: Completed
• Phase: N/A
• Start date: October 18, 2021
• Est. completion date: October 27, 2022

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to see how feasible a mobile app based virtual reality program for smoking cessation (MindCotine) would be among Stanford cancer center patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 27, 2022
• Est. primary completion date: October 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Daily cigarette smoker or some day smoker (>9 cigarettes per week)

• Age 18+

• English or Spanish fluent

• Smartphone compatibility

• Available to interact with a smartphone app for 6-weeks

• Available to complete the EOT assessment at end of 6-weeks

• Ability to understand and the willingness to personally sign the written IRB-approved informed consent document.

• Confirm phone, email, address during consent

Exclusion Criteria:

• Ever had epilepsy

• Less than 10 cigarettes per week

• Not English or Spanish fluent

• No smartphone compatibility

• Unavailable to interact with the VR program,

• Unavailable to answer questions about the intervention post-treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• MindCotine's VR app
The MindCotine program would be a 6-week intervention to help users utilize mindfulness based skills, and involves virtual exposure therapy.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Who Registered With the MindCotine Application	Total number of patients who registered with the app, out of total number of participants who were enrolled (eligible and willing to accept help with quitting). This measure is to assess whether MindCotine is a feasible smoking cessation option among patients who smoke cigarettes.	6 weeks
Primary	Number of Patients With Interest in the MindCotine Application	Total number of patients who expressed interest in the app, out of total number of participants who were screened for enrollment. This measure is to assess whether MindCotine is a feasible smoking cessation option among patients who smoke cigarettes.	6 weeks
Primary	Number of Patients Who Would Recommend the MindCotine Application as a Measure of Feasibility Among Patients Who Smoke.	Learning whether MindCotine is a feasible smoking cessation option among patients who smoke cigarettes.; Interest in using the app will be calculated as total number of patients who recommend the app to others.	6 weeks
Secondary	Number of Patients Who Attempt to Quit Smoking by Using the Application	Measured as the number of participants who had a 24-hour quit attempt in the past 6-weeks prior to end of treatment survey	6 weeks prior to end of treatment survey
Secondary	Number of Patients Using Cessation Medication by End of Treatment	Number of participants using cessation medications among those who completed the end of treatment survey.	6 weeks
Secondary	Number of MindCotine App Program Activities Completed	Program activities include VR-MET exercises and guided mindfulness-based two-dimensional video, audio, and reflection exercises.	6 weeks
Secondary	Number of MindCotine App Journal Entries Completed	Journal Record refers to CBT-based self-reflections.	6 weeks
Secondary	Number of MindCotine App Coaching Engagements Completed	Coaching Engagement refers to communicating with a coach through the MindCotine mobile application.	6 weeks
Secondary	Average Change in Cigarette Use	Average change in cigarette use from baseline to end of treatment among patients using the MindCotine app.	baseline to end of treatment, up to 6 weeks
Secondary	MindCotine Dropout	Number of patients who withdrew or were removed from the study.	6 weeks