Can a smartphone app help smokers quit for good?
NCT ID NCT07722832
First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This trial tests whether a digital medical device called Quitoxil®, which offers cognitive behavioral therapy and connects users with trained patient experts, can improve smoking cessation rates when added to standard nicotine replacement therapy. About 600 adults who smoke at least 5 cigarettes daily and want to quit will be randomly assigned to receive either standard care alone or standard care plus the Quitoxil® program. The main question is whether more people in the Quitoxil® group can stay smoke-free for at least 7 consecutive days after 6 months, confirmed by a breath test.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a digital medical device called Quitoxil® that provides cognitive behavioral therapy support, plus nicotine replacement therapies
- What this could lead to
- If effective, Quitoxil® could offer a new, accessible digital tool to help people quit smoking when used with standard treatments.
- What could go wrong
- This is a post-market study, not a proof-of-concept trial. The device is already available, so the question is how much extra benefit it provides. Results may vary by individual.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 606 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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