Clinical trial NCT05766553: Effects of Mindfulness Meditation in Virtual Reality on Craving and Smoking Cessation
Official title: Effects of Mindfulness Meditation in Virtual Reality on Craving and Smoking Cessation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Use Disorder
Keywords: relapse
craving
Lead sponsor: Centre Hospitalier Henri Laborit
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Relapse at 3 months
timeFrame: 3 months
measure: Relapse at 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Iteuil
country: France
facility: Cabinet Médical
city: Poitiers
country: France
facility: Cabinet médical des Couronneries
city: Poitiers
country: France
facility: Centre Hospitalier Henri Laborit
Study officials:
References: