NCT07722832尚未招募不适用
Evaluation of the Impact of the QUITOXIL® System on Smoking Cessation in Patients With Tobacco Use Disorder : a Randomized Controlled Clinical Trial.
KLAVA Innovation0 个研究点目标入组 606 人开始时间: 2026年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 606
- 主要终点
- Clinical impact of using the Quitoxil device in the management of smoking cessation
研究概览
简要总结
As part of post-marketing clinical monitoring and with a view to applying for the digital medical device Quitoxil® to be included on the LPPR list, this prospective, multicentre, controlled, randomised clinical trial aims to evaluate the clinical impact of support provided by Quitoxil® as an adjunct to conventional management for patients undergoing smoking cessation who have a tobacco use disorder.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged between 18 and 65
- •Who have understood and signed the informed consent form
- •With a tobacco use disorder according to the diagnostic criteria of the DSM-5 and ICD-
- •Daily smoker of manufactured or hand-roll , consuming at least 5 cigarettes per day for ≥ 12 months.
- •Expressing a desire to stop smoking
- •Having undergone a motivational interview, having completed, or completing during the inclusion visit, a Richmond Test with a score > 5 as part of the smoking cessation process.
- •Starting, at the inclusion visit or at , first-line nicotine replacement therapy (NRT), with a duration of use not exceeding one month prior to inclusion.
- •Available to attend the scheduled visits and assessments, including setting aside 10 to 30 minutes per week throughout the study.
- •Owns a compatible smartphone (iOS ≥ 13.4 or Android ≥ 6.0) and has a valid email address.
- •Understand and be proficient in the French language, and be able to understand the study instructions.
- •Enrolled in or covered by a social security scheme, in accordance with local requirements
排除标准
- •Individuals who, at the time of inclusion ( ), have been receiving another form of non-pharmacological support for smoking cessation for more than one month (e.g. cognitive-behavioural therapy, psychotherapy, therapeutic education programmes, hypnosis, acupuncture, support groups, digital apps or tools to aid cessation, helplines, or any other behavioural or non-pharmacological intervention).
- •Anyone deemed by the investigator to lack autonomy.
- •Difficulties using a smartphone
- •Presenting with severe, unstabilised psychiatric disorders (defined as a patient admitted to a psychiatric ward), in particular: acute or transient psychotic disorders, bipolar disorder type I or II, other unstabilised bipolar or related disorders.
- •Participating in another interventional research trial (with the exception of the IMPULSION programme - Implementation of lung cancer screening in the population)
- •A person subject to a compulsory treatment order under a court order.
- •A person under guardianship, curatorship, judicial protection, or any other administrative or judicial measure resulting in a partial or total deprivation of rights and freedoms.
研究组 & 干预措施
Managed by TSN in combination with the use of the Quitoxil® device
Experimental
干预措施: Quitoxil® (Device)
Treated with TSN only at inclusion (from enrolment to 6 months)
Sham Comparator
干预措施: Nicotine Replacement Therapies (Drug)
Managed by TSN in combination with the use of the Quitoxil® device
Experimental
干预措施: Nicotine Replacement Therapies (Drug)
结局指标
主要结局
Clinical impact of using the Quitoxil device in the management of smoking cessation
时间窗: 6 months
Self-reported smoking abstinence at 6 months (24 weeks) for 7 consecutive days prior to the visit, confirmed by a biochemical measurement of exhaled carbon monoxide (CO) ≤ 10 ppm.
次要结局
未报告次要终点
研究者
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