Evaluation of the Efficacy of QUITOXIL® in Smoking Cessation
ConditionTobacco Use Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKLAVA Innovation
About this 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Quitoxil®
- Nicotine Replacement Therapies
Treatment groups
606 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov