Tobacco Use Cessation3DSmokeNCT04610931
Study of the Effectiveness of a Virtual Reality Treatment in the Management of Smoking Cessation
A study testing Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT) and cognitive behavior therapy in people with Tobacco Use Cessation, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Tobacco is an addiction with serious consequences: somatic, psychiatric... The number of requests for treatment for tobacco addiction is gradually increasing from year to year, but conventional treatments have limited effectiveness. New tools such as virtual reality could be used in this treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT) and cognitive behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2021to 7 Jan 2026
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female between 18 and 75 years of age
- Who smokes 10 or more cigarettes per day in the month prior to inclusion
- Who wants to quit smoking
- Who has a diagnosis of a smoking disorder with "craving" criteria according to DSM 5 criteria
- Who is able to speak and read French
- Who is covered by the French national health insurance system
- Who has a signed consent form
Who cannot join
- Subjects with decompensated psychiatric co-morbidities (DSM 5) or unstable organic disease
- Subjects at serious suicide risk
- Subjects with other substance use disorders (DSM 5)
- Problems that interact with 3D exposure: tendency to dissociation; interceptive phobias (panic attacks and hypochondria...); severe dizziness.
- Cognitive problems that limit or prevent the ability to implement coping strategies or the management of emotions or stimuli and disabilities to complete the questionnaires
- Subjects belonging to a protected population such as pregnant women, breastfeeding women, guardians
- Subjects deprived of liberty by judicial or administrative decision, subject to psychiatric treatment under duress, minor subject, or unable to express their consent
- Who refuses to participate
Trial locations and contacts
1 site in 1 country.
France1 site
Clermont-Ferrand University Hospital
Clermont-Ferrand, Auvergne, 63000
About this study
Tobacco is an addiction with serious consequences: somatic, psychiatric... The number of requests for treatment for tobacco addiction is gradually increasing from year to year, but conventional treatments have limited effectiveness. New tools such as virtual reality could be used in this treatment. We propose to create a virtual reality program based on the analysis of high-risk relapse situations. The investigator will then evaluate the effect of this cybertherapy on patients' relapse time and their desire to smoke.
Read the detailed description
Smoking is the leading cause of morbidity and mortality, making it one of the most serious public health problems in the world. The majority of smokers would like to stop smoking and the number of smokers seeking treatment has increased by 25% between 2017 and 2018 in France. Indeed, many effective interventions have been developed to stop smoking, but many patients continue to relapse after a quit attempt. Only 10% to 30% achieve long-term abstinence and the majority relapse.
The therapeutic approach to addiction is based on a bio-psycho-social model. It aims to limit the runaway of subcortical processes (the cause of craving) via a medicinal approach and to strengthen the cortical control mechanisms via a psychotherapeutic approach.
As far as psychotherapeutic approaches are concerned, they seek to obtain a modification of cognitions and emotions related to tobacco through, for example, a relearning of the management of the product mediated by evocation or exposure. This may involve, for example, the repeated presentation (or evocation) of a signal (e.g. a place of consumption...), previously linked to consumption but in the absence of a reinforcer (product consumption). Most addiction remediation therapies have been developed and practiced with "imagination" (the patient is asked to think of stimulating situations) but they are difficult to control (because the patient's imagination can be more or less large) and are rarely used with situations that induce consumption. In this context the use of a 3Dimension (3D) tool, which allows a controlled and progressive exposure without confrontation, seems an interesting perspective. Virtual reality is recognized as a "tool" in the fields of neuroscience and psychology. It allows a patient-controlled exposure to complex, dynamic and three-dimensional stimuli.
Thus, virtual reality has logically been proposed as a tool in exposure therapies and its benefit has been measured in substance dependencies (Hone-Blanchet et al 2014). Since 2000, several researchers have successfully used virtual reality applications in addictions, but there is little data on objective evaluations of the effectiveness of cybertherapy in the treatment of tobacco addiction, particularly in association with the two reference treatments for smoking cessation that are nicotine substitution associated with cognitive behavioural therapy. For tobacco, the results are heterogeneous and did not take into account the different factors for maintaining tobacco use (Lee et al 2004, Choi et al 2011, Park et al 2014). Virtual therapy appears to be more effective when combined with other relapse prevention techniques such as cognitive behavioural therapy (CBT).
- Conditions
- Tobacco Use Cessation
- Being tested
- Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT), cognitive behavior therapy
- Keywords
- Addiction, Tobacco, Virtual Reality Exposure Therapy, Cognitive Behaviour Therapy
- Medical subject headings
- Tobacco Use Cessation, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT)Behavioural
Participants are smokers seeking treatment. Patients will be randomized into one of the 2 intervention groups.
In all cases, patients will receive nicotine replacement therapy. The second physician in charge of the usual tobacco monitoring will adjust the dosage.
Subjects in the usual treatment group will receive 6 weekly individual cognitive behavior therapy sessions lead by a psychologist. The content of CBT is similar in both groups. Subjects in the Virtual Reality group will receive 6 weekly individual CBT sessions followed by 6 virtual therapy sessions. Virtual therapy consists of exposing the patient to 3D situations considered to cause a high risk of smoking relapse and aiming to reduce signal reactivity by extinction. At each session, a neutral exposure will be given at the beginning to facilitate immersion and emergence of the session with a duration determined according to the sensitivity of each patient. Exposure is stopped when the craving approaches the baseline level.
cognitive behavior therapyBehavioural
Participants are smokers seeking treatment. Patients will be randomized into one of the 2 intervention groups. In all cases, patients will receive nicotine replacement therapy. The second physician in charge of the usual tobacco monitoring will adjust the dosage.
Subjects in the usual treatment group will receive 6 weekly individual cognitive behavior therapy sessions lead by a psychologist. The content of CBT is similar in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Cybertherapy | Experimental | use of cybertherapy (6 sessions) in addition to cognitive behavioral therapy (6 sessions) + pharmacological treatment Receives: Behavioral: Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT) |
| Treatment as usual | Active comparator | Treatment as usual is a cognitive behavioral therapy (6 sessions) + pharmacological treatment Receives: Behavioral: cognitive behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who quit smoking
Comparison of proportion of patients who quit smoking after 6 weeks after intervention in the 2 arms (declarative status verified by measurement of carbon monoxide level in the expired air) and until one year.
Measured: Day 43
Percentage of patients who quit smoking
Comparison of proportion of patients who quit smoking after 6 weeks after intervention in the 2 arms (declarative status verified by measurement of carbon monoxide level in the expired air) and until one year.
Measured: Day 136
Percentage of patients who quit smoking
Comparison of proportion of patients who quit smoking after 6 weeks after intervention in the 2 arms (declarative status verified by measurement of carbon monoxide level in the expired air) and until one year.
Measured: Day 229
Percentage of patients who quit smoking
Comparison of proportion of patients who quit smoking after 6 weeks after intervention in the 2 arms (declarative status verified by measurement of carbon monoxide level in the expired air) and until one year.
Measured: Day 408
Secondary outcomes (7)
smoking decreasing
Comparison between arms of mean/median number of cigarette smoke per day (declarative status and measurement of carbon monoxide level in the expired air)
Measured: Day 229, Day 408
Craving score
evaluation of craving score with Tabacco Craving Questionnary sort Form questionnaire (7 to 84; 7 no craving and 84 highest craving) ; comparison between arms at different endpoints
Measured: Day 1, Day 43, Day 74, Day 136, Day 229, Day 408
Needing score
It is evaluated with an analogical visual scale (1 to 10; 1 the lowest 10 the highest); comparison between arms at different endpoints
Measured: Day 1, Day 43, Day 74, Day 136, Day 229, Day 408
e-health score
It is evaluated with disease simulation questionnaire (French Speach Spatial en Quality -SSQ-vf- questionnaire)(/16)
Measured: Day 1, Day 43
Follow-up of all virtual reality sessions
Follow-up of all virtual reality sessions is assessed at 6 weeks post-inclusion
Measured: Day 43
Relapse rate
Relapse rate is the percentage of participants who are abstinent at the end of treatment and who relapse during the follow-up period; comparison between arms at different endpoints
Measured: Day 1, Day 43, Day 74, Day 136, Day 229, Day 408
Level of anxiety and depression
It is evaluated with the Hospital Anxiety and Depression - HAD scale (1 to 21; 1 no anxiety and depression , 21 highest symptoms); comparison between arms at different endpoints
Measured: Day 1, Day 43, Day 74, Day 136, Day 229, Day 408
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start2 Sep 2021
- Primary completion7 Jan 2026
- Study completion7 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random-sized block randomization, stratified on the number of previous relapses, will be performed for the inclusions of patients within the "cybertherapy" group or "Treatment as usual" group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610931
- Sponsor's protocol ID
- RBHP 2020 BROUSSE
- Acronym
- 3DSmoke
- Status last verified
- Feb 2026
- First submitted
- 16 Oct 2020
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effectiveness of a Virtual Reality Treatment in the Management of Smoking Cessation
- ClinicalTrials.gov ID
- NCT04610931
- Acronym / sponsor ID
- 3DSmoke / RBHP 2020 BROUSSE
- Conditions
- Tobacco Use Cessation
- Keywords
- Addiction, Tobacco, Virtual Reality Exposure Therapy, Cognitive Behaviour Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 7 Jan 2026 (actual)
- Study completion
- 7 Jan 2026 (actual)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tobacco is an addiction with serious consequences: somatic, psychiatric... The number of requests for treatment for tobacco addiction is gradually increasing from year to year, but conventional treatments have limited effectiveness. New tools such as virtual reality could be used in this treatment. We propose to create a virtual reality program based on the analysis of high-risk relapse situations. The investigator will then evaluate the effect of this cybertherapy on patients' relapse time and their desire to smoke.
Detailed description
Smoking is the leading cause of morbidity and mortality, making it one of the most serious public health problems in the world. The majority of smokers would like to stop smoking and the number of smokers seeking treatment has increased by 25% between 2017 and 2018 in France. Indeed, many effective interventions have been developed to stop smoking, but many patients continue to relapse after a quit attempt. Only 10% to 30% achieve long-term abstinence and the majority relapse.
The therapeutic approach to addiction is based on a bio-psycho-social model. It aims to limit the runaway of subcortical processes (the cause of craving) via a medicinal approach and to strengthen the cortical control mechanisms via a psychotherapeutic approach.
As far as psychotherapeutic approaches are concerned, they seek to obtain a modification of cognitions and emotions related to tobacco through, for example, a relearning of the management of the product mediated by evocation or exposure. This may involve, for example, the repeated presentation (or evocation) of a signal (e.g. a place of consumption...), previously linked to consumption but in the absence of a reinforcer (product consumption). Most addiction remediation therapies have been developed and practiced with "imagination" (the patient is asked to think of stimulating situations) but they are difficult to control (because the patient's imagination can be more or less large) and are rarely used with situations that induce consumption. In this context the use of a 3Dimension (3D) tool, which allows a controlled and progressive exposure without confrontation, seems an interesting perspective. Virtual reality is recognized as a "tool" in the fields of neuroscience and psychology. It allows a patient-controlled exposure to complex, dynamic and three-dimensional stimuli.
Thus, virtual reality has logically been proposed as a tool in exposure therapies and its benefit has been measured in substance dependencies (Hone-Blanchet et al 2014). Since 2000, several researchers have successfully used virtual reality applications in addictions, but there is little data on objective evaluations of the effectiveness of cybertherapy in the treatment of tobacco addiction, particularly in association with the two reference treatments for smoking cessation that are nicotine substitution associated with cognitive behavioural therapy. For tobacco, the results are heterogeneous and did not take into account the different factors for maintaining tobacco use (Lee et al 2004, Choi et al 2011, Park et al 2014). Virtual therapy appears to be more effective when combined with other relapse prevention techniques such as cognitive behavioural therapy (CBT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Random-sized block randomization, stratified on the number of previous relapses, will be performed for the inclusions of patients within the "cybertherapy" group or "Treatment as usual" group
| Arm | Type | Receives |
|---|---|---|
| Cybertherapy | Experimental | Behavioral: Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT)use of cybertherapy (6 sessions) in addition to cognitive behavioral therapy (6 sessions) + pharmacological treatment |
| Treatment as usual | Active comparator | Behavioral: cognitive behavior therapyTreatment as usual is a cognitive behavioral therapy (6 sessions) + pharmacological treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female between 18 and 75 years of age
- Who smokes 10 or more cigarettes per day in the month prior to inclusion
- Who wants to quit smoking
- Who has a diagnosis of a smoking disorder with "craving" criteria according to DSM 5 criteria
- Who is able to speak and read French
Key exclusion criteria (8 listed)
- Subjects with decompensated psychiatric co-morbidities (DSM 5) or unstable organic disease
- Subjects at serious suicide risk
- Subjects with other substance use disorders (DSM 5)
- Problems that interact with 3D exposure: tendency to dissociation; interceptive phobias (panic attacks and hypochondria...); severe dizziness.
- Cognitive problems that limit or prevent the ability to implement coping strategies or the management of emotions or stimuli and disabilities to complete the questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT)Participants are smokers seeking treatment. Patients will be randomized into one of the 2 intervention groups. In all cases, patients will receive nicotine replacement therapy. The second physician in charge of the usual tobacco monitoring will adjust the dosage. Subjects in the usual treatment group will receive 6 weekly individual cognitive behavior therapy sessions lead by a psychologist. The content of CBT is similar in both groups. Subjects in the Virtual Reality group will receive 6 weekly individual CBT sessions followed by 6 virtual therapy sessions. Virtual therapy consists of exposing the patient to 3D situations considered to cause a high risk of smoking relapse and aiming to reduce signal reactivity by extinction. At each session, a neutral exposure will be given at the beginning to facilitate immersion and emergence of the session with a duration determined according to the sensitivity of each patient. Exposure is stopped when the craving approaches the baseline level. | Behavioural | Cybertherapy |
| cognitive behavior therapyParticipants are smokers seeking treatment. Patients will be randomized into one of the 2 intervention groups. In all cases, patients will receive nicotine replacement therapy. The second physician in charge of the usual tobacco monitoring will adjust the dosage. Subjects in the usual treatment group will receive 6 weekly individual cognitive behavior therapy sessions lead by a psychologist. The content of CBT is similar in both groups. | Behavioural | Treatment as usual |
Primary outcome
Percentage of patients who quit smoking
Time frame: Day 43
Comparison of proportion of patients who quit smoking after 6 weeks after intervention in the 2 arms (declarative status verified by measurement of carbon monoxide level in the expired air) and until one year.
Percentage of patients who quit smoking
Time frame: Day 136
Comparison of proportion of patients who quit smoking after 6 weeks after intervention in the 2 arms (declarative status verified by measurement of carbon monoxide level in the expired air) and until one year.
Percentage of patients who quit smoking
Time frame: Day 229
Comparison of proportion of patients who quit smoking after 6 weeks after intervention in the 2 arms (declarative status verified by measurement of carbon monoxide level in the expired air) and until one year.
Percentage of patients who quit smoking
Time frame: Day 408
Comparison of proportion of patients who quit smoking after 6 weeks after intervention in the 2 arms (declarative status verified by measurement of carbon monoxide level in the expired air) and until one year.
7 secondary outcomes
smoking decreasing
Time frame: Day 229, Day 408
Craving score
Time frame: Day 1, Day 43, Day 74, Day 136, Day 229, Day 408
Needing score
Time frame: Day 1, Day 43, Day 74, Day 136, Day 229, Day 408
e-health score
Time frame: Day 1, Day 43
Follow-up of all virtual reality sessions
Time frame: Day 43
Relapse rate
Time frame: Day 1, Day 43, Day 74, Day 136, Day 229, Day 408
Level of anxiety and depression
Time frame: Day 1, Day 43, Day 74, Day 136, Day 229, Day 408
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT) and cognitive behavior therapy in people with Tobacco Use Cessation, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 7 inclusion and 8 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 4 Feb 2026. 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 France. 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?
Percentage of patients who quit smoking (time frame: Day 43). 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?
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 4 Feb 2026.