Evaluation of the Efficacy of QUITOXIL® in Smoking Cessation

Starting soon · Not applicable

Conditions studied: Tobacco Use Disorder

In brief

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.

Key facts

Study ID

NCT07722832

Run by

KLAVA Innovation

People needed

606

Starts

2026-10-01

Expected to finish

2028-04-01

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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