Stanford Tobacco Treatment Services - Virtual Reality Treatment for Smoking Cessation

• Sponsor: Stanford University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05220254
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 11.1
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation	Behavioral: MindCotine's VR app	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Stanford Tobacco Treatment Services - Virtual Reality Treatment for Smoking Cessation
• Actual Study Start Date: Oct 18, 2021
• Anticipated Primary Completion Date: Aug 31, 2022
• Anticipated Study Completion Date: Sep 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MindCotine mobile app program	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.

Outcome Measures

Primary Outcome Measures

1. MindCotine Application acceptability among smoking patients [6 weeks]

   Learning whether MindCotine is a feasible smoking cessation option among patients from the who smoke cigarettes daily. Interest in using the app will be calculated as 19 out of out of the total number of patients invited to use the app minus 1

Secondary Outcome Measures

1. Number of patients who attempt to quit smoking by using the application [6 weeks]

   Calculation of the mean change in reported cigarettes per day from baseline to EOT

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Daily cigarette smoker

• 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:

• Had epilepsy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Palo Alto	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

None specified.

Study Documents (Full-Text)

• Informed Consent Form - May 17, 2022

More Information

Publications

None provided.

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT05220254
• Other Study ID Numbers: IRB-60253
• First Posted: Feb 2, 2022
• Last Update Posted: Aug 24, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Stanford University: MindCotine

Study Results

No Results Posted as of Aug 24, 2022