VR Smoking Cessation Program for Quitting Smoking

Recruiting in Palo Alto (17 mi)

Overseen by Belinda Borrelli, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Boston University

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this randomized controlled trial (RCT) is to test whether a smoking cessation induction intervention delivered during a dental cleaning appointment increases the utilization of evidence-based treatments (EBTs) for smoking cessation within 7 months post-dental cleaning appointment. Approximately 400 cigarette smokers who are scheduled for a dental cleaning appointment at the Boston University Goldman School of Dental Medicine (BUGSDM) patient treatment center will be recruited and enrolled. Participants will be randomized to either the intervention or control group

Do I have to stop taking my current medications to join the trial?

Yes, if you are currently using medications for smoking cessation or smoking reduction, you cannot participate in this trial.

What data supports the idea that VR Smoking Cessation Program for Quitting Smoking is an effective treatment?

The available research shows that text messaging, which is a part of the VR Smoking Cessation Program, is effective in helping people quit smoking. It has been shown to increase the likelihood of attending smoking cessation clinic appointments and can encourage people to use web-based tools for quitting. Text messaging is widely used and can be a helpful tool in supporting people to stop smoking. Compared to other methods like self-help booklets, web-based interventions with tailored messages, which can include text messaging, have been more effective in reducing tobacco use. ^{1 2 3 4 5}

What safety data exists for the VR Smoking Cessation Program?

The available research primarily focuses on text messaging programs for smoking cessation, which are related to the VR Smoking Cessation Program. These studies indicate that text messaging interventions are generally well-received and show promise in helping people quit smoking. Participants in these programs reported high satisfaction and engagement, with no significant safety concerns mentioned. However, specific safety data for the VR Smoking Cessation Program itself is not detailed in the provided research. ^{6 7 8 9 10}

Is the VR Smoking Cessation Program a promising treatment for quitting smoking?

Yes, the VR Smoking Cessation Program is a promising treatment. It uses virtual reality to engage smokers, even those not ready to quit, by showing them videos during dental cleanings. Participants found it satisfying and informative, and many reported increased motivation to quit smoking. Some even quit smoking after using the program. ^{2 7 8 11 12}

Research Team

Belinda Borrelli, PhD

Principal Investigator

Henry M Goldman School of Dental Medicine

Eligibility Criteria

This trial is for Massachusetts residents who smoke cigarettes, have smoked over 100 in their lifetime, and use text messaging. They must be patients at the Boston University Dental Medicine center with an upcoming dental appointment, able to understand study materials, watch a video, and wear headphones. Excluded are those already in smoking cessation studies or using cessation meds.

Inclusion Criteria

I have smoked cigarettes in the last week.

Patient of the Boston University, Henry M Goldman School of Dental Medicine treatment center with an upcoming dental hygiene appointment (dental prophylaxis or scaling and root planing)

Is able to understand written and spoken study materials

Exclusion Criteria

Failure to show up to scheduled dental appointment at the clinic

Previous participation in the pilot phase

Could not watch video during dental appointment

Treatment Details

Interventions

• Assessment text messages (Behavioural Intervention)
• Brochure of smoking cessation EBTs (Behavioural Intervention)
• Control video (Behavioural Intervention)
• Experimental smoking cessation video (Behavioural Intervention)
• Tailored text message program (Behavioural Intervention)

Trial Overview The study tests if a smoking cessation video and follow-up texts during a dental visit can increase the use of proven quitting methods within 7 months post-visit. Participants will either receive this intervention or control content randomly during their scheduled cleaning at BUGSDM.

Participant Groups

Group I: Intervention group Experimental Treatment 3 Interventions

Participants randomized into the intervention arm will watch smoking cessation videos (ready to quit or not ready to quit) during a dental cleaning clinic visit, receive a brochure about EBTs, and participate in a 4-week text message program which consists of automated and tailored text messages to motivate EBT utilization. After the 4-week program, the intervention group will receive monthly assessment text messages.

Group II: Control group Active Control 3 Interventions

Participants randomized into the control arm will watch a control video during a dental hygiene visit and receive a brochure about EBTs, and a 4-week assessment-only text message program.

Who Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials

494

Recruited

9,998,000+

Sophie Kornowski

Boston University

Chief Executive Officer since 2022

MBA from the University of Chicago, Doctorate in Pharmacy from Paris Descartes University

Dr. Patrizia Cavazzoni

Boston University

Chief Medical Officer

MD from McGill University

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Recruited

853,000+

Janice S. Lee

National Institute of Dental and Craniofacial Research (NIDCR)

Clinical Director

DDS, MD, MS

Jennifer Webster-Cyriaque

National Institute of Dental and Craniofacial Research (NIDCR)

Acting Director

DDS, PhD

Findings from Research

A text messaging (SMS) program developed for adult smokers in primary care received high ratings for clarity and usefulness, with 96% of messages rated positively by participants.

Patients expressed a desire for personalized messages, inclusion of e-cigarette information, and graphics, while also identifying gaps in knowledge about nicotine replacement therapy (NRT) safety and effectiveness, highlighting the importance of tailoring interventions to meet smokers' needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining Real-Time Ratings With Qualitative Interviews to Develop a Smoking Cessation Text Messaging Program for Primary Care Patients. Kruse, G., Park, ER., Shahid, NN., et al.[2023]

The study aims to enhance adherence to a web-based smoking cessation program by integrating a text messaging intervention, focusing on four key features: personalisation, integration, dynamic tailoring, and message intensity, with 860 adult smokers participating in the initial phase.

In the second phase, 600 adult smokers will be randomly assigned to either the web-based program alone or the program combined with the optimized text messaging intervention, with the goal of measuring the impact on smoking cessation rates after 9 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimising text messaging to improve adherence to web-based smoking cessation treatment: a randomised control trial protocol. Graham, AL., Jacobs, MA., Cohn, AM., et al.[2019]

The Tobacco Tactics website, designed for veterans, underwent usability testing and received positive feedback, leading to over 27 modifications to enhance user experience, with 83% of participants finding it enjoyable and easy to navigate.

In a pilot study, veterans using the Tobacco Tactics website along with nicotine replacement therapy achieved a 40% abstinence rate at 30 days, compared to only 13% in the control group, indicating its potential effectiveness in helping veterans quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of the tobacco tactics website. Duffy, SA., Fowler, KE., Flanagan, PS., et al.[2021]

A study involving 102 young adult smokers found that a smartphone application (REQ-Mobile) was feasible for smoking cessation support, with 75% of users rating it as user-friendly.

However, the text messaging system (onQ) was more effective in promoting abstinence, with a significant number of users reporting higher rates of quitting compared to those using the app.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of a smartphone mobile application compared to text messaging to support smoking cessation. Buller, DB., Borland, R., Bettinghaus, EP., et al.[2022]

In a study of 436 patients at a smoking cessation clinic, sending SMS reminders significantly improved attendance at follow-up visits, which was linked to higher smoking cessation rates.

Patients who attended at least one follow-up visit had a smoking cessation rate of 34.5%, compared to only 19.1% for those who did not attend any visits, highlighting the importance of appointment compliance in achieving smoking cessation success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Short Message Service Increase Adherence to Smoking Cessation Clinic Appointments and Quitting Smoking? Önür, ST., Uysal, MA., İliaz, S., et al.[2019]

The Text2Quit program, which sends personalized text messages and emails to support smoking cessation, was well-received by university students, with 90.5% liking the program at 2 weeks and 82.3% at 4 weeks after enrollment.

Participants engaged actively with the program, averaging 11.8 responses to texts in the first 4 weeks, indicating that the interactive features, especially tracking cigarette use, were effective in maintaining user involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text2Quit: results from a pilot test of a personalized, interactive mobile health smoking cessation program. Abroms, LC., Ahuja, M., Kodl, Y., et al.[2022]

The Quit the Vape (QTV) program, which includes automated text messaging for e-cigarette cessation, showed high engagement and satisfaction among participants, with over 85% responding to messages and 55.6% reporting satisfaction compared to only 17.7% in the control group.

Adding live text counseling (QTV-C) appeared to enhance quitting outcomes, with 27.8% of participants achieving 7-day point prevalence abstinence, compared to 11.1% for QTV alone and 5.9% for the control group, suggesting that this combination may be more effective for e-cigarette cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of automated and counselor-delivered text messages for e-cigarette cessation. Krishnan, N., Berg, CJ., Le, D., et al.[2023]

The automated txt2stop smoking cessation program delivered via text messaging significantly increased biochemically verified continuous abstinence rates at 6 months, with 10.7% of participants in the txt2stop group quitting compared to 4.9% in the control group.

This study, involving 5,800 participants, demonstrates that mobile phone text messaging can be an effective tool for supporting smoking cessation, suggesting its potential inclusion in public health smoking cessation services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation support delivered via mobile phone text messaging (txt2stop): a single-blind, randomised trial. Free, C., Knight, R., Robertson, S., et al.[2022]

In a study involving 924 smokers using the QuitTxt program, most participants (68.9%) preferred the default messaging frequency of 4-8 texts per day, and the median duration of use was 27 days, indicating a generally positive reception of the program.

Despite some users not fully reporting their quit status, many still found QuitTxt helpful, suggesting that consistent reporting may not be crucial for the program's effectiveness in supporting smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How do smokers use a smoking cessation text messaging intervention? Balmford, J., Borland, R.[2018]

A study involving 3971 participants showed that web-based tailored behavioral smoking cessation materials significantly improved continuous abstinence rates compared to non-tailored materials, with rates of 29.0% vs. 23.9% at 6 weeks and 22.8% vs. 18.1% at 12 weeks.

Participants using the tailored program reported higher satisfaction levels, indicating that personalized support in smoking cessation can enhance both effectiveness and user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a web-based computer-tailored smoking cessation program as a supplement to nicotine patch therapy. Strecher, VJ., Shiffman, S., West, R.[2015]

In a pilot study involving 120 participants, the virtual reality-based intervention Mindcotine led to a significantly higher rate of smoking abstinence at postintervention (23%) compared to the control group (5%), indicating its potential effectiveness in tobacco cessation.

Participants using Mindcotine also showed greater readiness to quit smoking and a higher adherence rate to the program, with 41% completing the recommended treatment, suggesting that digital interventions can enhance engagement in smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Smartphone-Based Intervention for Smoking Cessation: Pilot Randomized Controlled Trial on Initial Clinical Efficacy and Adherence. Goldenhersch, E., Thrul, J., Ungaretti, J., et al.[2020]

A study involving 23 adult smokers during dental cleanings showed that using a virtual reality (VR) headset to watch smoking cessation videos did not interfere with dental care and was well-received by participants, with an average satisfaction rating of 5.4 out of 7.

The intervention positively impacted participants' willingness to quit smoking, with 14 out of 23 reporting they intentionally quit for at least 24 hours, and many participants recalling key information from the videos, suggesting VR could be an effective tool for promoting smoking cessation in dental settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivery of a smoking cessation induction intervention via virtual reality headset during a dental cleaning. Borrelli, B., Rueras, N., Jurasic, M.[2021]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Combining Real-Time Ratings With Qualitative Interviews to Develop a Smoking Cessation Text Messaging Program for Primary Care Patients. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Optimising text messaging to improve adherence to web-based smoking cessation treatment: a randomised control trial protocol. [2019]

3. Canada pubmed.ncbi.nlm.nih.gov

The development of the tobacco tactics website. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Randomized trial of a smartphone mobile application compared to text messaging to support smoking cessation. [2022]

5. Turkey pubmed.ncbi.nlm.nih.gov

Does Short Message Service Increase Adherence to Smoking Cessation Clinic Appointments and Quitting Smoking? [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Text2Quit: results from a pilot test of a personalized, interactive mobile health smoking cessation program. [2022]

7. Greece pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of automated and counselor-delivered text messages for e-cigarette cessation. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Smoking cessation support delivered via mobile phone text messaging (txt2stop): a single-blind, randomised trial. [2022]

9. England pubmed.ncbi.nlm.nih.gov

How do smokers use a smoking cessation text messaging intervention? [2018]

10. England pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a web-based computer-tailored smoking cessation program as a supplement to nicotine patch therapy. [2015]

11. Canada pubmed.ncbi.nlm.nih.gov

Virtual Reality Smartphone-Based Intervention for Smoking Cessation: Pilot Randomized Controlled Trial on Initial Clinical Efficacy and Adherence. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Delivery of a smoking cessation induction intervention via virtual reality headset during a dental cleaning. [2021]