Tobacco AddictionTABAPSYNCT06926153
Interventional Study on Smoking Reduction in Psychiatry
A study testing TABAPSY in people with Tobacco Addiction, run by GCS-CCOMS at 22 sites in 3 countries.
Trial summary
The smoking rate among people with mental disorders is higher than in the general population. Greater exposure to the harmful effects of tobacco partly explains the major inequality in life expectancy observed among people with mental disorders who, depending on the disorder and the study, live 10 to 25 years less… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Addiction
- What is being tested?
- TABAPSY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,500 participants
- Where
- 22 sitesin 3 countries
- Study dates
- 15 Jan 2025to 14 Nov 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Regular smokers (at least one cigarette per day)
- Followed in psychiatric ambulatory care at one of the participating sectors' CMPs
- Adults (18 years or older)
- Covered by the statuary health insurance
- Who gave their informed consent to participate to the study
Who cannot join
- Users under guardianship or legal protection,
- Psychological state incompatible with completing the questionnaire,
- Persons with no command or understanding of the French language
Trial locations and contacts
22 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 3 countries
France19 sites, 1 recruiting
- Completed
Public mental health establishment of Lille Metropole (59G16-G17)
Armentières, 59280
- Completed
Public mental health establishment of Lille Metropole (59G21)
Armentières, 59280
- Completed
Flanders public mental health establishment (59G05/06)
Bailleul, 59270
- Recruiting
Barthelemy Durand public health establishment (91G05)
Étampes, 91150
Amina AMRANDI, MD, + 33 1 69 46 86 66, amina.amrandi@eps-etampes.fr
Amina AMRANDI, MD
- Completed
Psychotherapeutic center of Nancy (54G02-06)
Laxou, 54520
- Withdrawn
University Hospital Center of Lille (59G08)
Lille, 59000
- Completed
Hospital Care Center of Nanterre (92G10)
Nanterre, 92014
- Completed
University Hospital Group Paris Neurosciences & Psychiatry (75G04)
Paris, 75014
- Completed
Hospital Center of Rouffach (68G02/03)
Rouffach, 68250
- Completed
Hospital Center of Rouffach (68G08/09)
Rouffach, 68250
- Completed
Hospital Center of Rouffach (Pôle LTD - 68G04/05)
Rouffach, 68250
- Completed
Hospitals of Paris Est Val de Marne (94G01)
Saint-Maurice, 94410
- Completed
Hospitals of Paris Est Val de Marne (94G16)
Saint-Maurice, 94410
- Completed
Hospitals of Paris Est Val de Marne (Paris 11)
Saint-Maurice, 94410
- Completed
Hospitals of Paris Est Val de Marne (Paris 12)
Saint-Maurice, 94410
- Completed
Hospitals of Paris Est Val de Marne (Paris Centre)
Saint-Maurice, 94410
- Completed
Public mental health establishment of Val de Lys Artois (62G09)
Saint-Venant, 62350
- Completed
Public mental health establishment of Val de Lys Artois (62G12)
Saint-Venant, 62350
- Completed
Public mental health establishment of Val de Lys Artois (Pôle du Ternois)
Saint-Venant, 62350
Guadeloupe2 sites, 2 recruiting
- Recruiting
Public mental health establishment of Guadeloupe (96G01)
Saint-Claude, 97122
Daniel CAPERET, MD, +590 5 90 80 52 62, Daniel.CAPERET@epsm-guadeloupe.fr
Magloire MPEMBI, MD
- Recruiting
Public mental health establishment of Guadeloupe (96G06)
Saint-Claude, 97122
Isabelle DELAROZIERE, MD, +590 5 90 41 48 68, isabelle.delaroziere@epsm-guadeloupe.fr
Isabelle DELAROZIERE, MD
Reunion1 site
- Completed
Public mental health establishment of Reunion Island (Pôle Nord)
Saint-Paul, 97460
About this study
Official title: Evaluation of an Intervention to Reduce Smoking Among Mental Health Users Treated in Ambulatory Psychiatry
The smoking rate among people with mental disorders is higher than in the general population. Greater exposure to the harmful effects of tobacco partly explains the major inequality in life expectancy observed among people with mental disorders who, depending on the disorder and the study, live 10 to 25 years less than the general population, a gap mainly due to the occurrence of cardiovascular and respiratory pathologies, notably bronchial cancers. However, tobacco reduction actions specifically targeting these people remain insufficiently developed, particularly in psychiatry where this addiction is often banalized and its treatment neglected.
The objective of this study is to evaluate an intervention ('Tabapsy') co-constructed with mental health services users, mental health professionals, and general practitioners and targeting adult patients followed in ambulatory psychiatry. The main objective is to evaluate the effectiveness of the intervention on short-term smoking cessation (cessation for at least 7 days) among regular smokers at 3 months. Secondary objectives include evaluation of its cost-effectiveness and implementation. To this end, a national cluster-randomized controlled study will be carried out, supplemented by qualitative interviews to study the implementation of the intervention.
Read the detailed description
The smoking rate among people with mental disorders is higher than in the general population. Greater exposure to the harmful effects of tobacco partly explains the major inequality in life expectancy observed among people with mental disorders who, depending on the disorder and the study, live 10 to 20 years less than the general population, a gap mainly due to the occurrence of cardiovascular and respiratory pathologies, notably bronchial cancers.
While studies found that people under psychiatric care are as motivated as others to stop smoking, the literature also shows that psychiatric care systems tolerate, underestimate and even encourage smoking among users, despite the fact that psychiatric care, whether at hospital or in an ambulatory setting, is conducive to changes in smoking behaviour and to the implementation of a smoking cessation approach, notably because of anti-smoking regulations in hospitals. In addition, withdrawal symptoms is stronger in this population and smoking cessation would therefore need to be adapted.
Against this backdrop, a smoking cessation intervention ('Tabapsy') was co-constructed with the various stakeholders (users with mental disorders, mental health professionals and general practitioners). Its aim is to encourage and support smoking cessation among people with mental disorders followed in ambulatory psychiatry by medical psychological centers (CMP). It consists of two parts: a campaign to promote smoking cessation within the CMP, and the setting up of an intervention to help people stop smoking. The latter comprises of:
- A general information meeting, to encourage motivation to start smoking cessation;
- An assessment workshop, to evaluate level of dependence using validated tests and establish a personalized cessation program based on the results obtained;
- Five thematic workshops to support cessation, covering 1/ nicotine replacement treatments, electronic cigarettes and other drug treatments available for smoking cessation, 2/ emotional management, 3/ weight gain, 4/ physical activities, and 5/ manual occupations;
- Peer support groups, based on the sharing of experiences, to encourage mutual aid and solidarity between people with mental disorders who are trying to quit smoking.
The intervention also relies on a facilitator specifically recruited to set up the intervention and run the various workshops in the CMP. It is complemented by a website that will contain all the resources and information presented during the meetings/workshops.
The primary objective of the study is to evaluate the effectiveness of the "Tabapsy" intervention on short-term smoking cessation (cessation for at least 7 days) at 3 months among regular smokers followed by adult psychiatric CMPs. Secondary objectives include assessing its cost-effectiveness and implementation.
A cluster-randomized controlled trial will be carried out to evaluate the intervention. The cluster is the "psychiatric sector", i.e., the public care entity responsible for organizing the mental health care of a population within a pre-specified geographical area (including hospital and ambulatory care) in France. A psychiatric sector may include one or multiple CMPs depending on the size of the population it serves. Psychiatric sectors will be randomized into one of two groups (intervention or usual practice).
It will be supplemented by a qualitative study to study the implementation of the intervention.
All regular smokers (at least one cigarette a day) who agree to participate will be asked to complete questionnaires on a WebApp at inclusion, and again at 3 and 6 months. Additional questionnaires will be available in the intervention group. Questions will focus on user characteristics, tobacco consumption, level of nicotine dependence, motivation to quit, use of cessation aids, level of mental and physical well-being, smoking-related knowledge and representations, and in the intervention group, participation in the intervention and satisfaction.
6,250 participants will be included over 12 months, in 22 participating sectors.
- Conditions
- Tobacco Addiction
- Being tested
- TABAPSY, Usual Care
- Keywords
- Smoking reduction, People with mental disorders, Psychiatry
- Medical subject headings
- Smoking Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TABAPSYOther
The Tabapsy intervention consists in a campaign to promote smoking cessation within the CMP, and an intervention to help people stop smoking which comprises of a) A general information meeting; b) An assessment workshop, to evaluate level of dependence using validated tests and establish a personalized cessation program based on the results obtained; c) Five thematic workshops to support cessation, covering 1/ nicotine replacement treatments, electronic cigarettes and other drug treatments available for smoking cessation, 2/ emotional management, 3/ weight gain, 4/ physical activities, and 5/ manual occupations; d) Peer support groups, based on the sharing of experiences, to encourage mutual aid and solidarity between people with mental disorders who are trying to quit smoking.
The intervention relies on a facilitator specifically recruited to implement and run the intervention in the CMP. It is complemented by a website that will contain all the resources and information presented dur
Usual CareOther
Usual care corresponds to usual practices regarding smoking cessation activities in participating sectors. Those practices may vary (enquiring whether a patient is a smoker or not, offering smoking cessation if they are or only if the patient asks, etc.)
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Sectors randomized to the intervention group will implement the 'Tabapsy' intervention. Receives: Other: TABAPSY |
| Usual care | Other | Sectors randomized to the control group will continue implementing their usual smoking cessation promotion. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term smoking cessation
Short-term smoking cessation corresponds to a smoking cessation of at least 7 days, assessed among regular smoker (at least one cigarette a day) included in the study.
Measured: 3 months
Secondary outcomes (17)
Motivation to stop smoking
The motivation to stop smoking will be assessed using the Q-Mat ("Questionnaire de motivation à l'arrêt du tabac") scale. The computed score ranges from 0 to 20, 20 representing the highest motivation.
Measured: 3 and 6 months
Voluntary quit attempts lasting at least 24 hours in the last 3 months
Number of voluntary quit attempts assessed both as percentage of users reporting at least one quit attempt and mean number of quit attempts per use
Measured: 3 and 6 months
Voluntary quit attempts lasting at least 7 days in the last 3 months
Number of voluntary quit attempts assessed both as percentage of users reporting at least one quit attempt and mean number of quit attempts per user.
Measured: 3 and 6 months
Tobacco consumption
Number of cigarettes smoked per day
Measured: 3 and 6 months
Nicotine dependence
Nicotine dependence will be measured by the 6-question Fagerström test.
Measured: 3 and 6 months
Short-term smoking cessation
Short-term smoking cessation corresponds to a smoking cessation of at least 7 days, assessed among regular smoker (at least one cigarette a day) included in the study.
Measured: 6 months
Medium-term smoking cessation
Medium-term smoking cessation corresponds to a smoking cessation of at least 30 days, assessed among regular smoker (at least one cigarette a day) included in the study.
Measured: At 3 and 6 months
Use of smoking cessation aids
Number of participants using smoking cessation aids (nicotine replacement therapy and other smoking cessation medications (varenicline or bupropion), electronic cigarettes, and health professionals, assessed together and separately
Measured: 3 and 6 months
Level of mental well-being
Level of mental well-being assessed with a visual analog scale ranging from 1 to 10, 10 representing the highest level of mental well-being
Measured: 3 and 6 months
Level of physical well-being
Level of physical well-being assessed with a visual analog scale ranging from 1 to 10, 10 representing the highest level of physical well-being
Measured: 3 and 6 months
Knowledge and representations surrounding tobacco use
Knowledge and representations surrounding tobacco use will be assessed using a dedicated questionnaire addressed to all the included population as well as to patients who participated to a given workshop
Measured: 3 and 6 months
Cost-effectiveness (short-term)
Incremental cost-effectiveness ratio in cost per additional weaning of at least 7 days.
Measured: A 6 months
Cost-effectiveness (long-term)
Incremental cost-effectiveness ratio in cost per life-year gained over the entire life of users, using extrapolated data and economic modeling (Markov model) to assess lifetime costs and effectiveness 'till all patients in the model are deceased.
Measured: 6 months
Budgetary impact (costs)
Direct costs will be calculated with and without the Tabapsy intervention to assess the budgetary impact of its generalization.
Measured: 5 years after hypothetical generalization
Budgetary impact (health benefits)
The number of users who have stopped smoking for at least 7 days will be calculated with and without the Tabapsy intervention to assess the health gains associated with its generalization.
Measured: 5 years after hypothetical generalization
Implementation
The implementation of the intervention and its components will be assessed using qualitative methods through semi-structured interviews conducted with 25 mental health users et 25 mental health professionnals of the intervention group).
Measured: 6 months
Satisfaction level
Users who participated in one of the components of the intervention will be asked to rate their satisfaction using a visual analog scale ranging from 0 to 10, with 10 corresponding to the highest satisfaction.
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start15 Jan 2025
- Primary completion15 Jul 2026
- Study completion14 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco AddictionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GCS-CCOMS
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM ECEVE 1123
- Responsible party
- Sponsor
- Investigators
- Jean-Luc ROELANDT, MD, Principal investigator, GCS-CCOMS & INSERM ECEVE 1123Karine CHEVREUL, MD and Pr of public health, Study director, Evaluation and research in health services and policies for vulnerable populations, French National Institute for Health and Medical Research (INSERM ECEVE 11 23)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926153
- Sponsor's protocol ID
- 2024-A01474-43
- Other IDs
- A19017HS
- Acronym
- TABAPSY
- Status last verified
- Oct 2026
- First submitted
- 18 Feb 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Intervention to Reduce Smoking Among Mental Health Users Treated in Ambulatory Psychiatry
- ClinicalTrials.gov ID
- NCT06926153
- Acronym / sponsor ID
- TABAPSY / 2024-A01474-43
- Conditions
- Tobacco Addiction
- Keywords
- Smoking reduction, People with mental disorders, Psychiatry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,500 participants (estimated)
- Lead sponsor
- GCS-CCOMSUniversity, hospital or other
- Collaborators
- INSERM ECEVE 1123
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 14 Nov 2026 (estimated)
- First posted
- 13 Apr 2025 (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.
The smoking rate among people with mental disorders is higher than in the general population. Greater exposure to the harmful effects of tobacco partly explains the major inequality in life expectancy observed among people with mental disorders who, depending on the disorder and the study, live 10 to 25 years less than the general population, a gap mainly due to the occurrence of cardiovascular and respiratory pathologies, notably bronchial cancers. However, tobacco reduction actions specifically targeting these people remain insufficiently developed, particularly in psychiatry where this addiction is often banalized and its treatment neglected.
The objective of this study is to evaluate an intervention ('Tabapsy') co-constructed with mental health services users, mental health professionals, and general practitioners and targeting adult patients followed in ambulatory psychiatry. The main objective is to evaluate the effectiveness of the intervention on short-term smoking cessation (cessation for at least 7 days) among regular smokers at 3 months. Secondary objectives include evaluation of its cost-effectiveness and implementation. To this end, a national cluster-randomized controlled study will be carried out, supplemented by qualitative interviews to study the implementation of the intervention.
Detailed description
The smoking rate among people with mental disorders is higher than in the general population. Greater exposure to the harmful effects of tobacco partly explains the major inequality in life expectancy observed among people with mental disorders who, depending on the disorder and the study, live 10 to 20 years less than the general population, a gap mainly due to the occurrence of cardiovascular and respiratory pathologies, notably bronchial cancers.
While studies found that people under psychiatric care are as motivated as others to stop smoking, the literature also shows that psychiatric care systems tolerate, underestimate and even encourage smoking among users, despite the fact that psychiatric care, whether at hospital or in an ambulatory setting, is conducive to changes in smoking behaviour and to the implementation of a smoking cessation approach, notably because of anti-smoking regulations in hospitals. In addition, withdrawal symptoms is stronger in this population and smoking cessation would therefore need to be adapted.
Against this backdrop, a smoking cessation intervention ('Tabapsy') was co-constructed with the various stakeholders (users with mental disorders, mental health professionals and general practitioners). Its aim is to encourage and support smoking cessation among people with mental disorders followed in ambulatory psychiatry by medical psychological centers (CMP). It consists of two parts: a campaign to promote smoking cessation within the CMP, and the setting up of an intervention to help people stop smoking. The latter comprises of:
- A general information meeting, to encourage motivation to start smoking cessation;
- An assessment workshop, to evaluate level of dependence using validated tests and establish a personalized cessation program based on the results obtained;
- Five thematic workshops to support cessation, covering 1/ nicotine replacement treatments, electronic cigarettes and other drug treatments available for smoking cessation, 2/ emotional management, 3/ weight gain, 4/ physical activities, and 5/ manual occupations;
- Peer support groups, based on the sharing of experiences, to encourage mutual aid and solidarity between people with mental disorders who are trying to quit smoking.
The intervention also relies on a facilitator specifically recruited to set up the intervention and run the various workshops in the CMP. It is complemented by a website that will contain all the resources and information presented during the meetings/workshops.
The primary objective of the study is to evaluate the effectiveness of the "Tabapsy" intervention on short-term smoking cessation (cessation for at least 7 days) at 3 months among regular smokers followed by adult psychiatric CMPs. Secondary objectives include assessing its cost-effectiveness and implementation.
A cluster-randomized controlled trial will be carried out to evaluate the intervention. The cluster is the "psychiatric sector", i.e., the public care entity responsible for organizing the mental health care of a population within a pre-specified geographical area (including hospital and ambulatory care) in France. A psychiatric sector may include one or multiple CMPs depending on the size of the population it serves. Psychiatric sectors will be randomized into one of two groups (intervention or usual practice).
It will be supplemented by a qualitative study to study the implementation of the intervention.
All regular smokers (at least one cigarette a day) who agree to participate will be asked to complete questionnaires on a WebApp at inclusion, and again at 3 and 6 months. Additional questionnaires will be available in the intervention group. Questions will focus on user characteristics, tobacco consumption, level of nicotine dependence, motivation to quit, use of cessation aids, level of mental and physical well-being, smoking-related knowledge and representations, and in the intervention group, participation in the intervention and satisfaction.
6,250 participants will be included over 12 months, in 22 participating sectors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: TABAPSYSectors randomized to the intervention group will implement the 'Tabapsy' intervention. |
| Usual care | Other | Other: Usual CareSectors randomized to the control group will continue implementing their usual smoking cessation promotion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Regular smokers (at least one cigarette per day)
- Followed in psychiatric ambulatory care at one of the participating sectors' CMPs
- Adults (18 years or older)
- Covered by the statuary health insurance
- Who gave their informed consent to participate to the study
Key exclusion criteria (3 listed)
- Users under guardianship or legal protection,
- Psychological state incompatible with completing the questionnaire,
- Persons with no command or understanding of the French language
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 |
|---|---|---|
| TABAPSYThe Tabapsy intervention consists in a campaign to promote smoking cessation within the CMP, and an intervention to help people stop smoking which comprises of a) A general information meeting; b) An assessment workshop, to evaluate level of dependence using validated tests and establish a personalized cessation program based on the results obtained; c) Five thematic workshops to support cessation, covering 1/ nicotine replacement treatments, electronic cigarettes and other drug treatments available for smoking cessation, 2/ emotional management, 3/ weight gain, 4/ physical activities, and 5/ manual occupations; d) Peer support groups, based on the sharing of experiences, to encourage mutual aid and solidarity between people with mental disorders who are trying to quit smoking. The intervention relies on a facilitator specifically recruited to implement and run the intervention in the CMP. It is complemented by a website that will contain all the resources and information presented dur | Other | Intervention arm |
| Usual CareUsual care corresponds to usual practices regarding smoking cessation activities in participating sectors. Those practices may vary (enquiring whether a patient is a smoker or not, offering smoking cessation if they are or only if the patient asks, etc.) | Other | Usual care |
Primary outcome
Short-term smoking cessation
Time frame: 3 months
Short-term smoking cessation corresponds to a smoking cessation of at least 7 days, assessed among regular smoker (at least one cigarette a day) included in the study.
17 secondary outcomes
Motivation to stop smoking
Time frame: 3 and 6 months
Voluntary quit attempts lasting at least 24 hours in the last 3 months
Time frame: 3 and 6 months
Voluntary quit attempts lasting at least 7 days in the last 3 months
Time frame: 3 and 6 months
Tobacco consumption
Time frame: 3 and 6 months
Nicotine dependence
Time frame: 3 and 6 months
Short-term smoking cessation
Time frame: 6 months
Medium-term smoking cessation
Time frame: At 3 and 6 months
Use of smoking cessation aids
Time frame: 3 and 6 months
Level of mental well-being
Time frame: 3 and 6 months
Level of physical well-being
Time frame: 3 and 6 months
Knowledge and representations surrounding tobacco use
Time frame: 3 and 6 months
Cost-effectiveness (short-term)
Time frame: A 6 months
Cost-effectiveness (long-term)
Time frame: 6 months
Budgetary impact (costs)
Time frame: 5 years after hypothetical generalization
Budgetary impact (health benefits)
Time frame: 5 years after hypothetical generalization
Implementation
Time frame: 6 months
Satisfaction level
Time frame: 3 and 6 months
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 8 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Jean-Luc ROELANDT, MD principal investigator
GCS-CCOMS & INSERM ECEVE 1123
Karine CHEVREUL, MD and Pr of public health study director
Evaluation and research in health services and policies for vulnerable populations, French National Institute for Health and Medical Research (INSERM ECEVE 11 23)
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TABAPSY in people with Tobacco Addiction, run by GCS-CCOMS at 22 sites in 3 countries.
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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in France, Guadeloupe, Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Contact Jean-Luc ROELANDT, MD (+33 3 20 43 71 00, jean-luc.roelandt@ghtpsy-npdc.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term smoking cessation (time frame: 3 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 8 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.