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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCentre Hospitalier Henri Laborit

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual reality pod

    Other intervention

    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

    Other intervention

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Interventional GroupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Relapse at 3 months

Relapse of patients by declaring their consumption at 3 months.

Time frame
3 months
2

Relapse at 6 months

Relapse of patients by declaring their consumption at 6 months.

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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