Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05766553

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

Led by Centre Hospitalier Henri Laborit · Updated on 2026-01-13

200

Participants Needed

3

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Smoking 10 to 40 cigarettes per day
  • Men or women aged 18 to 75 years inclusive
  • Diagnosed with substance use disorder according to DSM5
  • Covered by social security or eligible through a third party as per French law on human research
  • Provided signed informed consent after receiving written information
Not Eligible

You will not qualify if you...

  • Disabling cognitive disorders
  • Under 18 or over 75 years old
  • Psychological or psychiatric disorder requiring specialized follow-up
  • Addiction to substances other than tobacco
  • Cardiological conditions detected by ECG that could affect participation (for experimental group)
  • Advanced pulmonary, renal, hepatic diseases, or other serious unstable medical conditions judged by doctor
  • Pregnant or breastfeeding women
  • Participating in another clinical trial simultaneously
  • Employees of the investigator or trial site
  • Legally protected individuals
  • Do not speak French
  • Not covered by state health insurance
  • Unable to complete study questionnaires
  • Claustrophobic or anxious about using the virtual reality cabin
  • Allergic to any component in nicotine substitutes

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Cabinet Médical

Iteuil, France

Actively Recruiting

2

Cabinet médical des Couronneries

Poitiers, France

Actively Recruiting

3

Centre Hospitalier Henri Laborit

Poitiers, France

Actively Recruiting

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Research Team

N

Nematollah JAAFARI

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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