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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

606 Participants

are divided into 2 treatment groups

Group A: Treated with TSN only at inclusion (from enrolment to 6 months)Sham comparator 1 intervention

Group B: Managed by TSN in combination with the use of the Quitoxil® deviceExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame

6 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

KLAVA Innovation

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: