Study of the Effectiveness of a Virtual Reality Treatment in the Management of Smoking Cessation (NCT04610931) | Clinical Trial Compass
CompletedNot Applicable
Study of the Effectiveness of a Virtual Reality Treatment in the Management of Smoking Cessation
France74 participantsStarted 2021-09-02
Plain-language summary
Tobacco is an addiction with serious consequences: somatic, psychiatric... The number of requests for treatment for tobacco addiction is gradually increasing from year to year, but conventional treatments have limited effectiveness. New tools such as virtual reality could be used in this treatment. We propose to create a virtual reality program based on the analysis of high-risk relapse situations. The investigator will then evaluate the effect of this cybertherapy on patients' relapse time and their desire to smoke.
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:
* Male or female between 18 and 75 years of age
* Who smokes 10 or more cigarettes per day in the month prior to inclusion
* Who wants to quit smoking
* Who has a diagnosis of a smoking disorder with "craving" criteria according to DSM 5 criteria
* Who is able to speak and read French
* Who is covered by the French national health insurance system
* Who has a signed consent form
Exclusion Criteria:
* Subjects with decompensated psychiatric co-morbidities (DSM 5) or unstable organic disease
* Subjects at serious suicide risk
* Subjects with other substance use disorders (DSM 5)
* Problems that interact with 3D exposure: tendency to dissociation; interceptive phobias (panic attacks and hypochondria...); severe dizziness.
* Cognitive problems that limit or prevent the ability to implement coping strategies or the management of emotions or stimuli and disabilities to complete the questionnaires
* Subjects belonging to a protected population such as pregnant women, breastfeeding women, guardians
* Subjects deprived of liberty by judicial or administrative decision, subject to psychiatric treatment under duress, minor subject, or unable to express their consent
* Who refuses to participate
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.