NCT05220254

Stanford Tobacco Treatment Services - Virtual Reality Treatment for Smoking Cessation

Completed NA Results posted Last updated 18 December 2023

What this trial tests

NA trial testing MindCotine's VR app in Smoking Cessation in 20 participants. Completed in 27 October 2022.

Timeline

18 October 2021

Primary endpoint
27 October 2022

27 October 2022

Quick facts

Lead sponsor	Stanford University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	20
Start date	18 October 2021
Primary completion	27 October 2022
Estimated completion	27 October 2022
Sites	1 location across United States

Drugs / interventions tested

• MindCotine's VR app

Conditions studied

• Smoking Cessation — all drugs for Smoking Cessation →
• MindCotine Virtual Reality Mindful Exposure Therapy — all drugs for MindCotine Virtual Reality Mindful Exposure Therapy →

Sponsor

Stanford University

Who can join

18 and older, any sex, with Smoking Cessation or MindCotine Virtual Reality Mindful Exposure Therapy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients Who Registered With the MindCotine Application Primary · 6 weeks

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.

Group	Value	95% CI
MindCotine Mobile App Program	9

Number of Patients With Interest in the MindCotine Application Primary · 6 weeks

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.

Group	Value	95% CI
MindCotine Mobile App Program	27

Number of Patients Who Would Recommend the MindCotine Application as a Measure of Feasibility Among Patients Who Smoke. Primary · 6 weeks

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.

Group	Value	95% CI
MindCotine Mobile App Program	7

Number of Patients Who Attempt to Quit Smoking by Using the Application Secondary · 6 weeks prior to end of treatment survey

Measured as the number of participants who had a 24-hour quit attempt in the past 6-weeks prior to end of treatment survey

Group	Value	95% CI
MindCotine Mobile App Program	4

Number of Patients Using Cessation Medication by End of Treatment Secondary · 6 weeks

Number of participants using cessation medications among those who completed the end of treatment survey.

Group	Value	95% CI
MindCotine Mobile App Program	5

Number of MindCotine App Program Activities Completed Secondary · 6 weeks

Program activities include VR-MET exercises and guided mindfulness-based two-dimensional video, audio, and reflection exercises.

Group	Value	95% CI
MindCotine Mobile App Program	13	± 20.2

Number of MindCotine App Journal Entries Completed Secondary · 6 weeks

Journal Record refers to CBT-based self-reflections.

Group	Value	95% CI
MindCotine Mobile App Program	19	± 26

Number of MindCotine App Coaching Engagements Completed Secondary · 6 weeks

Coaching Engagement refers to communicating with a coach through the MindCotine mobile application.

Group	Value	95% CI
MindCotine Mobile App Program	11	± 12.3

Average Change in Cigarette Use Secondary · baseline to end of treatment, up to 6 weeks

Average change in cigarette use from baseline to end of treatment among patients using the MindCotine app.

Group	Value	95% CI
MindCotine Mobile App Program	-4.1	± 8

MindCotine Dropout Secondary · 6 weeks

Number of patients who withdrew or were removed from the study.

Group	Value	95% CI
MindCotine Mobile App Program	5

Adverse events — posted to ClinicalTrials.gov

Time frame: 9 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MindCotine Mobile App Program

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (6 terms — click to expand)

Reaction	System	MindCotine Mobile App Prog…
Dizziness	Nervous system disorders	—
Nausea	Gastrointestinal disorders	—
Disorientation	Nervous system disorders	—
Double vision	Nervous system disorders	—
Headache	Nervous system disorders	—
Lighheadedness	Nervous system disorders	—

Data from ClinicalTrials.gov NCT05220254 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Adding Virtual Reality Mindful Exposure Therapy to a Cancer Center's Tobacco Treatment Offerings: Feasibility and Acceptability Single-Group Pilot Study.
   Jackson RW, Cao-Nasalga A, Chieng A, Pirkl A, et al · · 2024 · cited 1× · PMID 39042439 · DOI 10.2196/54817