Evaluation of the Efficacy of QUITOXIL® in Smoking Cessation

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.

Inclusion Criteria: * 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-10. * 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 Exclusion Criteria: * 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.