Evaluation of the Efficacy of QUITOXIL® in Smoking Cessation

Evaluation of the Impact of the QUITOXIL® System on Smoking Cessation in Patients With Tobacco Use Disorder : a Randomized Controlled Clinical Trial.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Drug: Nicotine Replacement Therapies; Device: Quitoxil®

• Study Type: Interventional
• Enrollment (Estimated): 606
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Treated with TSN only at inclusion (from enrolment to 6 months)	Drug: Nicotine Replacement Therapies; Nicotine replacement therapies (NRTs) are treatments that deliver controlled doses of nicotine without tobacco to help people reduce withdrawal symptoms and quit smoking.
Experimental: Managed by TSN in combination with the use of the Quitoxil® device	Drug: Nicotine Replacement Therapies; Nicotine replacement therapies (NRTs) are treatments that deliver controlled doses of nicotine without tobacco to help people reduce withdrawal symptoms and quit smoking.; Device: Quitoxil®; Quitoxil® is the first CE-marked (Class I) digital medical device in France dedicated to helping people quit smoking. Its support programme, structured around two modules and eight themes, offers an integrative approach specifically developed in line with the principles of cognitive behavioural therapy and facilitates contact with patient experts certified in addiction treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical impact of using the Quitoxil device in the management of smoking cessation	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.	6 months

Collaborators and Investigators

• Sponsor: KLAVA Innovation

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 23, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Tobacco Use Disorder; Therapeutics; Drug Therapy; Nicotine Replacement Therapy
• Other Study ID Numbers: KLAVA RCT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No