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Smoking CessationNCT07013084

Study on the Effect of Digital Smoking Cessation Education Intervention on Outpatients

A study testing 3D VR smoking cessation program in people with Smoking Cessation, run by National Taiwan Normal University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aimed to assess the novel approach of an immersive three-dimensional (3D) virtual reality (VR) smoking cessation program and its effectiveness on smoking outpatients Read more about this study

Who is it for?
Ages 20 to 64 years
Conditions the study is for
Smoking Cessation
What is being tested?
3D VR smoking cessation program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteTaiwan
Study dates
12 Oct 2020to 4 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • currently receiving outpatient care at the smoking cessation clinic
  • self-reported current tobacco use
  • aged between 20 and 64 years
  • no participation in any smoking cessation intervention within the past 12 months

Who cannot join

  • Patients with medical contraindications that could prevent them from engaging with the VR equipment

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Tri-Service General Hospital SongShan Branch ,Taipei,Taiwan

    Taipei

Other trials in Taiwan

About this study

This study aimed to assess the novel approach of an immersive three-dimensional (3D) virtual reality (VR) smoking cessation program and its effectiveness on smoking outpatients

Read the detailed description

A randomized controlled trial (RCT) was conducted with 100 outpatients from a smoking cessation clinic in Taiwan. Participants were randomly assigned to either the experimental group (n=50) or the comparison group (n=50) through a coin toss. The experimental group received standard outpatient smoking cessation services in combination with an immersive 3D VR smoking cessation program, while the comparison group received only standard outpatient services. The VR program included five interactive modules that used immersive scenarios to simulate smoking-related cues and provide educational content, employing cognitive-behavioral techniques and practicing coping strategies to promote behavior change.

Being tested
3D VR smoking cessation program
Keywords
smoking cessation, virtual reality, outpatient
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3D VR smoking cessation programBehavioural

    Participants in the experimental group engaged with the VR system using a head-mounted display, allowing for full immersion in the virtual environment.

Study groups in NCT07013084
Study groupRoleWhat they receive
3D VR smoking cessation interventionExperimentalThe program consists of five sequential VR modules, each structured as an interactive game scenario targeting specific aspects of smoking behavior and cessation motivation.
Receives: Behavioral: 3D VR smoking cessation program
comparison groupNo interventionno 3D VR smoking cessation program intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. smoking status indicator1

    Participants reported the number of days they smoked in the past 30 days

    Measured: From enrollment to the end of intervention at 12 weeks

  2. smoking status indicator2

    Participants reported the average number of cigarettes consumed per day in the past 30 days

    Measured: From enrollment to the end of intervention at 12 weeks

  3. smoking status indicator3

    Nicotine dependence was measured using the FTND.

    Measured: From enrollment to the end of intervention at 12 weeks

  4. smoking status indicator4

    exhaled CO levels were measured using a handheld CO monitor

    Measured: From enrollment to the end of intervention at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2025
  2. Study start12 Oct 2020
  3. Primary completion23 May 2023
  4. Study completion4 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07013084
Sponsor's protocol ID
C202005128
Status last verified
May 2025
First submitted
26 May 2025
Last updated
10 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chun HR, Cheon E, Hwang JE. Systematic review of changed smoking behaviour, smoking cessation and psychological states of smokers according to cigarette type during the COVID-19 pandemic. BMJ Open. 2022 Jun 14;12(6):e055179. doi: 10.1136/bmjopen-2021-055179.

    PubMed 35701057

  • Keijsers M, Vega-Corredor MC, Tomintz M, Hoermann S. Virtual Reality Technology Use in Cigarette Craving and Smoking Interventions (I "Virtually" Quit): Systematic Review. J Med Internet Res. 2021 Sep 17;23(9):e24307. doi: 10.2196/24307.

    PubMed 34533471

  • Ebbert JO, Severson HH, Croghan IT, Danaher BG, Schroeder DR. Comparative effectiveness of the nicotine lozenge and tobacco-free snuff for smokeless tobacco reduction. Addict Behav. 2013 May;38(5):2140-5. doi: 10.1016/j.addbeh.2013.01.023. Epub 2013 Feb 4.

    PubMed 23454876

  • Tonnesen P, Lauri H, Perfekt R, Mann K, Batra A. Efficacy of a nicotine mouth spray in smoking cessation: a randomised, double-blind trial. Eur Respir J. 2012 Sep;40(3):548-54. doi: 10.1183/09031936.00155811. Epub 2012 Feb 9.

    PubMed 22323576

  • Caponnetto P, Cibella F, Mancuso S, Campagna D, Arcidiacono G, Polosa R. Effect of a nicotine-free inhalator as part of a smoking-cessation programme. Eur Respir J. 2011 Nov;38(5):1005-11. doi: 10.1183/09031936.00109610. Epub 2011 May 12.

    PubMed 21565921

  • Ward KD, Asfar T, Al Ali R, Rastam S, Weg MW, Eissenberg T, Maziak W. Randomized trial of the effectiveness of combined behavioral/pharmacological smoking cessation treatment in Syrian primary care clinics. Addiction. 2013 Feb;108(2):394-403. doi: 10.1111/j.1360-0443.2012.04048.x. Epub 2012 Nov 19.

    PubMed 22882805

  • Karekla M, Savvides SN, Gloster A. An Avatar-Led Intervention Promotes Smoking Cessation in Young Adults: A Pilot Randomized Clinical Trial. Ann Behav Med. 2020 Oct 1;54(10):747-760. doi: 10.1093/abm/kaaa013.

    PubMed 32383736

  • Goldenhersch E, Thrul J, Ungaretti J, Rosencovich N, Waitman C, Ceberio MR. Virtual Reality Smartphone-Based Intervention for Smoking Cessation: Pilot Randomized Controlled Trial on Initial Clinical Efficacy and Adherence. J Med Internet Res. 2020 Jul 29;22(7):e17571. doi: 10.2196/17571.

    PubMed 32723722

  • Pericot-Valverde I, Secades-Villa R, Gutierrez-Maldonado J. A randomized clinical trial of cue exposure treatment through virtual reality for smoking cessation. J Subst Abuse Treat. 2019 Jan;96:26-32. doi: 10.1016/j.jsat.2018.10.003. Epub 2018 Oct 16.

    PubMed 30466545

  • Guo JL, Liao JY, Chang LC, Wu HL, Huang CM. The effectiveness of an integrated multicomponent program for adolescent smoking cessation in Taiwan. Addict Behav. 2014 Oct;39(10):1491-9. doi: 10.1016/j.addbeh.2014.05.009. Epub 2014 May 28.

    PubMed 24949950

  • Borrelli B, Rueras N, Jurasic M. Delivery of a smoking cessation induction intervention via virtual reality headset during a dental cleaning. Transl Behav Med. 2021 Feb 11;11(1):182-188. doi: 10.1093/tbm/ibz144.

    PubMed 31665495

  • Giovancarli C, Malbos E, Baumstarck K, Parola N, Pelissier MF, Lancon C, Auquier P, Boyer L. Virtual reality cue exposure for the relapse prevention of tobacco consumption: a study protocol for a randomized controlled trial. Trials. 2016 Feb 19;17:96. doi: 10.1186/s13063-016-1224-5.

    PubMed 26892001

  • Park CB, Choi JS, Park SM, Lee JY, Jung HY, Seol JM, Hwang JY, Gwak AR, Kwon JS. Comparison of the effectiveness of virtual cue exposure therapy and cognitive behavioral therapy for nicotine dependence. Cyberpsychol Behav Soc Netw. 2014 Apr;17(4):262-7. doi: 10.1089/cyber.2013.0253. Epub 2014 Feb 20.

    PubMed 24555521

  • Bordnick PS, Traylor AC, Carter BL, Graap KM. A Feasibility Study of Virtual Reality-Based Coping Skills Training for Nicotine Dependence. Res Soc Work Pract. 2012 May;22(3):293-300. doi: 10.1177/1049731511426880.

    PubMed 25484549

  • Pericot-Valverde I, Garcia-Rodriguez O, Gutierrez-Maldonado J, Ferrer-Garcia M, Secades-Villa R. Evolution of smoking urge during exposure through virtual reality. Stud Health Technol Inform. 2011;167:74-9.

    PubMed 21685645

Questions about this trial

What is this clinical trial studying?

A study testing 3D VR smoking cessation program in people with Smoking Cessation, run by National Taiwan Normal University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

smoking status indicator1 (time frame: From enrollment to the end of intervention at 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07013084, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.

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