- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07722832
Evaluation of the Efficacy of QUITOXIL® in Smoking Cessation
23. juli 2026 opdateret af: KLAVA Innovation
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
606
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Sham-komparator: Treated with TSN only at inclusion (from enrolment to 6 months)
|
Nicotine replacement therapies (NRTs) are treatments that deliver controlled doses of nicotine without tobacco to help people reduce withdrawal symptoms and quit smoking.
|
|
Eksperimentel: Managed by TSN in combination with the use of the Quitoxil® device
|
Nicotine replacement therapies (NRTs) are treatments that deliver controlled doses of nicotine without tobacco to help people reduce withdrawal symptoms and quit smoking.
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical impact of using the Quitoxil device in the management of smoking cessation
Tidsramme: 6 months
|
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. oktober 2026
Primær færdiggørelse (Anslået)
1. april 2028
Studieafslutning (Anslået)
1. april 2028
Datoer for studieregistrering
Først indsendt
20. juli 2026
Først indsendt, der opfyldte QC-kriterier
20. juli 2026
Først opslået (Faktiske)
23. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KLAVA RCT
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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