RecruitingNot ApplicableNCT05766553

Effects of Mindfulness Meditation in Virtual Reality on Craving and Smoking Cessation

Sponsor

Centre Hospitalier Henri Laborit

Enrollment

200 participants

Start Date

Jun 15, 2023

Study Type

INTERVENTIONAL

Conditions

Tobacco Use Disorder

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

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.

Exclusion Criteria15

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERVirtual reality pod

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.

OTHERnicotine patches and chewing gum

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.