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

Last updated: August 19, 2024
Sponsor: Centre Hospitalier Henri Laborit
Overall Status: Active - Recruiting

Phase

N/A

Condition

Tobacco Use Disorder

Treatment

nicotine patches and chewing gum

Virtual reality pod

Clinical Study ID

NCT05766553
2022-A02004-39
  • Ages 18-75
  • All Genders

Study 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

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 accordancewith French law on research involving the human person

  • Having signed the informed consent form after having received written information.

Exclusion

Exclusion Criteria:

  • Disabling cognitive disorders

  • Patient under 18 or over 75 years old.

  • Patient with a psychological disorder or a psychiatric pathology requiringspecialized 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 experimentalgroup).

  • Advanced pulmonary, renal, and hepatic diseases, or any unstable and serious medicalconditions that could compromise the patient's participation in the study, subjectto 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 thequestionnaires

  • Patient claustrophobic or anxious about using the cabin

  • Patient allergic to a molecule present in nicotine substitutes

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: nicotine patches and chewing gum
Phase:
Study Start date:
June 15, 2023
Estimated Completion Date:
December 15, 2026

Connect with a study center

  • Cabinet Médical

    Iteuil,
    France

    Active - Recruiting

  • Cabinet médical des Couronneries

    Poitiers,
    France

    Active - Recruiting

  • Centre Hospitalier Henri Laborit

    Poitiers,
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.