Effects of Mindfulness Meditation in Virtual Reality on Craving and Smoking Cessation (NCT05766553) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Mindfulness Meditation in Virtual Reality on Craving and Smoking Cessation
France200 participantsStarted 2023-06-15
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.