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

Tobacco Use Disorder Clinical Trial

— VIREAMIND  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05766553
• Other study ID #: 2022-A02004-39
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: December 15, 2026

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Henri Laborit
• Contact: Nematollah JAAFARI
• Phone: +33 5 16 52 61 18
• Email: nemat.jaafari[@]ch-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 15, 2026
• Est. primary completion date: October 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Other:
• Virtual 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.
• nicotine 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.

Locations

Country	Name	City	State
France	Cabinet Médical	Iteuil
France	Cabinet médical des Couronneries	Poitiers
France	Centre Hospitalier Henri Laborit	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Henri Laborit

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse at 3 months	Relapse of patients by declaring their consumption at 3 months.	3 months
Primary	Relapse at 6 months	Relapse of patients by declaring their consumption at 6 months.	6 months