Effects of Mindfulness Meditation in Virtual Reality on Craving and Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Relapse at 3 months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Interventional Group
Patients in this arm will have 6 sessions of virtual reality in a pod (1 session per week).
Patients will then have a visit at day 90 and day 180.
干预措施: Virtual reality pod (Other)
Control group
Patients in this arm will receive the gold standard of treatment for tobacco cessation (nicotine patches and chewing gum) from day 0 (inclusion visit) to day 90.
Patients will then have a visit at day 90 and day 180.
干预措施: nicotine patches and chewing gum (Other)
结局指标
主要结局
Relapse at 3 months
时间窗: 3 months
Relapse of patients by declaring their consumption at 3 months.
Relapse at 6 months
时间窗: 6 months
Relapse of patients by declaring their consumption at 6 months.
次要结局
未报告次要终点