Tobacco Use DisorderNCT07722832
Evaluation of the Efficacy of QUITOXIL® in Smoking Cessation
A study testing Quitoxil® and Nicotine Replacement Therapies in people with Tobacco Use Disorder, run by KLAVA Innovation.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Quitoxil® and Nicotine Replacement Therapies
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 606 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Tobacco Use Disorder
- Being tested
- Quitoxil®, Nicotine Replacement Therapies
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 TherapiesDrug
Nicotine replacement therapies (NRTs) are treatments that deliver controlled doses of nicotine without tobacco to help people reduce withdrawal symptoms and quit smoking.
| Study group | Role | What they receive |
|---|---|---|
| Treated with TSN only at inclusion (from enrolment to 6 months) | Sham comparator | Not described Receives: Drug: Nicotine Replacement Therapies |
| Managed by TSN in combination with the use of the Quitoxil® device | Experimental | Not described Receives: Device: Quitoxil®; Drug: Nicotine Replacement Therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 606 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KLAVA Innovation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722832
- Sponsor's protocol ID
- KLAVA RCT
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of the QUITOXIL® System on Smoking Cessation in Patients With Tobacco Use Disorder : a Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT07722832
- Acronym / sponsor ID
- KLAVA RCT
- Conditions
- Tobacco Use Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 606 participants (estimated)
- Lead sponsor
- KLAVA InnovationIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quitoxil®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 | Device | Managed by TSN in combination with the use of the Quitoxil® device |
| Nicotine Replacement TherapiesNicotine replacement therapies (NRTs) are treatments that deliver controlled doses of nicotine without tobacco to help people reduce withdrawal symptoms and quit smoking. | Drug | Managed by TSN in combination with the use of the Quitoxil® device, Treated with TSN only at inclusion (from enrolment to 6 months) |
Primary outcome
Clinical impact of using the Quitoxil device in the management of smoking cessation
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Quitoxil® and Nicotine Replacement Therapies in people with Tobacco Use Disorder, run by KLAVA Innovation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical impact of using the Quitoxil device in the management of smoking cessation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.