Effects of Mindfulness Meditation in Virtual Reality on Craving and Smoking Cessation
VIREAMIND
1 other identifier
interventional
200
1 country
3
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2023
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2023
CompletedFirst Posted
Study publicly available on registry
March 13, 2023
CompletedStudy Start
First participant enrolled
June 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 15, 2026
January 13, 2026
January 1, 2026
3.3 years
January 18, 2023
January 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Relapse at 3 months
Relapse of patients by declaring their consumption at 3 months.
3 months
Relapse at 6 months
Relapse of patients by declaring their consumption at 6 months.
6 months
Study Arms (2)
Interventional Group
EXPERIMENTALPatients 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 COMPARATORPatients 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Cabinet Médical
Iteuil, France
Cabinet médical des Couronneries
Poitiers, France
Centre Hospitalier Henri Laborit
Poitiers, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2023
First Posted
March 13, 2023
Study Start
June 15, 2023
Primary Completion (Estimated)
October 15, 2026
Study Completion (Estimated)
December 15, 2026
Last Updated
January 13, 2026
Record last verified: 2026-01