Evaluation of the Efficacy of QUITOXIL® in Smoking Cessation

Sponsor
KLAVA Innovation
Study ID
NCT07722832
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Tobacco Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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
  • 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.

Study Details

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 Dates

First listed
Jul 23, 2026
Start date
Oct 1, 2026
Status verified
Jul 2026
Primary completion
Apr 1, 2028
Completion
Apr 1, 2028

Study Design

Enrollment
606 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Treated with TSN only at inclusion (from enrolment to 6 months)
  • Experimental: Managed by TSN in combination with the use of the Quitoxil® device

Primary Outcome Measure

Clinical impact of using the Quitoxil device in the management of smoking cessation [ Time Frame: 6 months ]

Related Studies