Tobacco Use DisorderVIREAMINDNCT05766553
Effects of Mindfulness Meditation in Virtual Reality on Craving and Smoking Cessation
A study testing Virtual reality pod and nicotine patches and chewing gum in people with Tobacco Use Disorder, run by Centre Hospitalier Henri Laborit at 3 sites in France.
Trial summary
Investigators seek to propose a non-drug therapeutic alternative, namely a mindfulness meditation protocol based on virtual reality training in order to induce progressive modifications of various indicators of craving. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Virtual reality pod and nicotine patches and chewing gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesFrance
- Study dates
- 15 Jun 2023to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Any patient consuming 10 to 40 cigarettes per day
- Woman or man aged 18 to 75 inclusive
- Substance use disorder according to the DSM5 classification
- Benefit from social security or benefit from it through a third party in accordance with French law on research involving the human person
- Having signed the informed consent form after having received written information.
Who cannot join
- Disabling cognitive disorders
- Patient under 18 or over 75 years old.
- Patient with a psychological disorder or a psychiatric pathology requiring specialized follow-up
- Patient with addiction to another product.
- Cardiological pathologies that could compromise the participation of patients, detected by an ECG (only for patients who will be randomized in the experimental group).
- Advanced pulmonary, renal, and hepatic diseases, or any unstable and serious medical conditions that could compromise the patient's participation in the study, subject to the judgment of the doctor
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- Pregnant or breastfeeding woman
- Simultaneous participation in another trial
- Employee of the investigator or of the clinical trial site
- Patients protected by law
- Patients who do not speak the French language
- People not covered by state health insurance
- Patients who in the opinion of the investigator are unable to complete the questionnaires
- Patient claustrophobic or anxious about using the cabin
- Patient allergic to a molecule present in nicotine substitutes
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Cabinet Médical
Iteuil
Marc Besnier, MD, marc.besnier@hotmail.fr
- Recruiting
Cabinet médical des Couronneries
Poitiers
Lakshmipriya LE BONHEUR, MD, lak.lebonheur@gmail.com
- Recruiting
Centre Hospitalier Henri Laborit
Poitiers
Nemat Jaafari, PU-PH, nemat.jaafari@ch-poitiers.fr
About this study
Investigators seek to propose a non-drug therapeutic alternative, namely a mindfulness meditation protocol based on virtual reality training in order to induce progressive modifications of various indicators of craving.
The study hypothesis is that the practice of mindfulness meditation in a virtual reality environment reduces the craving induced by cues and stress and therefore ultimately smoking relapse.
Read more
The main objective of the protocol will be to demonstrate that mindfulness meditation can reduce long-term relapse (continuous cessation (> 30 days) of smoking cessation).
The participants will be randomized into two groups: the experimental group will perform six virtual reality sessions in a multisensory cabin at the rate of one session per week; the control group will be prescribed the gold standard treatment (nicotine patches and chewing gum).
Participants will be seen again at three and six months to assess whether or not there has been a smoking relapse.
- Conditions
- Tobacco Use Disorder
- Being tested
- Virtual reality pod, nicotine patches and chewing gum
- Keywords
- relapse, craving
- Medical subject headings
- Tobacco Use Disorder, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality podOther
The first two sessions provide guided training in relaxation and mindfulness through immersion in a virtual forest environment for the first session, and in a virtual beach environment for the second. Sessions 3 and 4 present environments with addiction-related stimuli (Cues). The session 3 consists of a walk through the virtual street environment, buying a bottle of water from the store, and then ordering a coffee from a virtual bar. The session 4 takes place in a virtual party environment in an apartment: people smoke and drink alcohol in the living room, the session consists of sitting with them, then going to the kitchen to get a water bottle. Sessions 5 and 6 present stressful environments. Session 5 consists of a virtual parachute jump. The 6th session takes place in a virtual airplane environment, which will encounter turbulence.
nicotine patches and chewing gumOther
Participants in this group will be prescribed a Gold Standard smoking cessation treatment with nicotine patches adapted to their consumption and 4mg nicotine chewing gum for a period of 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | Patients in this arm will have 6 sessions of virtual reality in a pod (1 session per week).
Patients will then have a visit at day 90 and day 180. Receives: Other: Virtual reality pod |
| Control group | Active comparator | Patients in this arm will receive the gold standard of treatment for tobacco cessation (nicotine patches and chewing gum) from day 0 (inclusion visit) to day 90.
Patients will then have a visit at day 90 and day 180. Receives: Other: nicotine patches and chewing gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse at 3 months
Relapse of patients by declaring their consumption at 3 months.
Measured: 3 months
Relapse at 6 months
Relapse of patients by declaring their consumption at 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start15 Jun 2023
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Henri Laborit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766553
- Sponsor's protocol ID
- 2022-A02004-39
- Acronym
- VIREAMIND
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2023
- Last updated
- 13 Jan 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 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mindfulness Meditation in Virtual Reality on Craving and Smoking Cessation
- ClinicalTrials.gov ID
- NCT05766553
- Acronym / sponsor ID
- VIREAMIND / 2022-A02004-39
- Conditions
- Tobacco Use Disorder
- Keywords
- relapse, craving
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Henri LaboritUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 13 Mar 2023 (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.
Investigators seek to propose a non-drug therapeutic alternative, namely a mindfulness meditation protocol based on virtual reality training in order to induce progressive modifications of various indicators of craving.
The study hypothesis is that the practice of mindfulness meditation in a virtual reality environment reduces the craving induced by cues and stress and therefore ultimately smoking relapse.
The main objective of the protocol will be to demonstrate that mindfulness meditation can reduce long-term relapse (continuous cessation (> 30 days) of smoking cessation).
The participants will be randomized into two groups: the experimental group will perform six virtual reality sessions in a multisensory cabin at the rate of one session per week; the control group will be prescribed the gold standard treatment (nicotine patches and chewing gum).
Participants will be seen again at three and six months to assess whether or not there has been a smoking relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Other: Virtual reality podPatients in this arm will have 6 sessions of virtual reality in a pod (1 session per week). Patients will then have a visit at day 90 and day 180. |
| Control group | Active comparator | Other: nicotine patches and chewing gumPatients in this arm will receive the gold standard of treatment for tobacco cessation (nicotine patches and chewing gum) from day 0 (inclusion visit) to day 90. Patients will then have a visit at day 90 and day 180. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Any patient consuming 10 to 40 cigarettes per day
- Woman or man aged 18 to 75 inclusive
- Substance use disorder according to the DSM5 classification
- Benefit from social security or benefit from it through a third party in accordance with French law on research involving the human person
- Having signed the informed consent form after having received written information.
Key exclusion criteria (15 listed)
- Disabling cognitive disorders
- Patient under 18 or over 75 years old.
- Patient with a psychological disorder or a psychiatric pathology requiring specialized follow-up
- Patient with addiction to another product.
- Cardiological pathologies that could compromise the participation of patients, detected by an ECG (only for patients who will be randomized in the experimental group).
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 podThe first two sessions provide guided training in relaxation and mindfulness through immersion in a virtual forest environment for the first session, and in a virtual beach environment for the second. Sessions 3 and 4 present environments with addiction-related stimuli (Cues). The session 3 consists of a walk through the virtual street environment, buying a bottle of water from the store, and then ordering a coffee from a virtual bar. The session 4 takes place in a virtual party environment in an apartment: people smoke and drink alcohol in the living room, the session consists of sitting with them, then going to the kitchen to get a water bottle. Sessions 5 and 6 present stressful environments. Session 5 consists of a virtual parachute jump. The 6th session takes place in a virtual airplane environment, which will encounter turbulence. | Other | Interventional Group |
| nicotine patches and chewing gumParticipants in this group will be prescribed a Gold Standard smoking cessation treatment with nicotine patches adapted to their consumption and 4mg nicotine chewing gum for a period of 3 months. | Other | Control group |
Primary outcome
Relapse at 3 months
Time frame: 3 months
Relapse of patients by declaring their consumption at 3 months.
Relapse at 6 months
Time frame: 6 months
Relapse of patients by declaring their consumption at 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality pod and nicotine patches and chewing gum in people with Tobacco Use Disorder, run by Centre Hospitalier Henri Laborit at 3 sites 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 5 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nematollah JAAFARI (+33 5 16 52 61 18, nemat.jaafari@ch-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse at 3 months (time frame: 3 months). The study lists 2 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 13 Jan 2026.