NCT05766553

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Centre Hospitalier Henri Laborit · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tobacco Use Disorder

Interventions

Type	Name	Description
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.
OTHER	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.

Timeline

• Start date: 2023-06-15
• Primary completion: 2026-10-15
• Completion: 2026-12-15
• First posted: 2023-03-13
• Last updated: 2026-01-13

Locations

3 sites across 1 country: France