Evaluation of the Efficacy of QUITOXIL® in Smoking Cessation

NCT07722832 | Not Yet Recruiting

• 1 other identifier: KLAVA RCT
• Study Type: interventional
• Target: 606
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Tobacco Use Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Treated with TSN only at inclusion (from enrolment to 6 months)

SHAM COMPARATOR

Drug: Nicotine Replacement Therapies

Managed by TSN in combination with the use of the Quitoxil® device

EXPERIMENTAL

Device: Quitoxil®; Drug: Nicotine Replacement Therapies

Interventions

Nicotine Replacement Therapies DRUG

Nicotine replacement therapies (NRTs) are treatments that deliver controlled doses of nicotine without tobacco to help people reduce withdrawal symptoms and quit smoking.

Managed by TSN in combination with the use of the Quitoxil® device; Treated with TSN only at inclusion (from enrolment to 6 months)

Quitoxil® DEVICE

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

Managed by TSN in combination with the use of the Quitoxil® device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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:

• 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.

Sponsors & Collaborators

• KLAVA Innovation: lead

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: July 24, 2026

Record last verified: 2026-07