Tobacco UsePriSanTabacNCT06873009
Can Cognitive Behavioural Therapy Help Incarcerated Men Quit Smoking? Efficacy and Predictors of Treatment Outcomes
A study testing Cognitive-Behavioral Therapy (CBT) for Smoking Cessation and Health Education Session on Tobacco Use in people with Tobacco Use and Smoking Cessation, run by Centre Hospitalier St Anne at 1 site in France.
Trial summary
The goal of this clinical trial is to evaluate whether a brief group-based psychological intervention using cognitive-behavioral therapy (CBT) helps people in prison quit smoking. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Tobacco Use, Smoking Cessation, Cognitive Behavioral Therapy
- What is being tested?
- Cognitive-Behavioral Therapy (CBT) for Smoking Cessation and Health Education Session on Tobacco Use
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2025to Mar 2027
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male individuals currently incarcerated at Maison d'Arrêt Paris-La Santé.
- Aged 18 years or older at the time of inclusion.
- Current smoker, defined as having smoked daily in the past 30 days, or having an occasional smoking pattern of at least 5 cigarettes during the past 30 days.
- Able to speak and understand French well enough to follow the study procedures and actively participate in group sessions.
- Sentence length of at least 6 months, or if in pretrial detention, having a scheduled trial date within at least 6 months.
Who cannot join
- Age under 18 years at the time of inclusion.
- Inability to speak and understand French well enough to follow the study procedures and actively participate in group sessions.
- Sentence length of less than 6 months, or if in pretrial detention, having a scheduled trial date in less than 6 months or no available information about the trial date.
- Severe cognitive impairment that affects comprehension and participation in the study.
- Unstable psychiatric conditions (including acute psychotic disorders, severe mood disorders, severe anxiety disorders).
- Individuals under legal guardianship or conservatorship (e.g., placed under tutelage, curatorship, or temporary guardianship).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre pénitentiaire Paris-La Santé (Paris-La Santé prison)
Paris, Île-de-France Region, 75014
About this study
Official title: Cognitive Behavioural Therapy for Smoking Cessation in Incarcerated Men: Efficacy and Predictors of Treatment Outcomes
The goal of this clinical trial is to evaluate whether a brief group-based psychological intervention using cognitive-behavioral therapy (CBT) helps people in prison quit smoking. Researchers will compare this intervention to a health education program and a control group (waitlist) to see which approach is most effective.
The main questions this study aims to answer are:
Read more
- Does the CBT-based group intervention help more participants quit smoking compared to the health education group and the control group?
- Do participants in the CBT-based group intervention smoke fewer cigarettes per day one month after the intervention compared to the other groups?
- Do participants in the CBT-based group intervention have lower nicotine dependence ?
- What individual factors (e.g., motivation to quit, nicotine dependence, craving intensity, self-efficacy, withdrawal symptoms, anxiety, depression, ADHD, and PTSD) predict success in the CBT and Health education groups?
Participants will be randomly assigned to one of three groups:
- CBT group: Three group sessions (1.5 hours each) using CBT and motivational approaches to quitting smoking.
- Health education group: One group session (1 hour) providing information on smoking and its health risks.
- Control group: No intervention for three months (waitlist). All participants will complete an initial assessment, attend their assigned group sessions, and return for follow-up visits at 1 month and 3 months. Their smoking status will be measured through self-reports and carbon monoxide (CO) expired levels.
- Being tested
- Cognitive-Behavioral Therapy (CBT) for Smoking Cessation, Health Education Session on Tobacco Use
- Keywords
- Tobacco use, Smoking cessation, Cognitive Behavioral Therapy, Prisoners
- Medical subject headings
- Tobacco Use, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral Therapy (CBT) for Smoking CessationBehavioural
A structured three-session group intervention (1.5 hours per session over three weeks) using cognitive-behavioral and motivational strategies to enhance motivation, manage cravings, and prevent relapse.
Associated Arm: CBT Group
Health Education Session on Tobacco UseOther
A single-session group intervention (1 hour) providing information on the health risks of tobacco use, addiction mechanisms, and the long-term benefits of quitting smoking.
Associated Arm: Health Education Group
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Behavioral Therapy (CBT) group | Experimental | Participants in this group will receive a cognitive-behavioral therapy (CBT)-based intervention designed to help them quit smoking. The intervention consists of three structured group sessions (1.5 hours each) over three weeks, incorporating cognitive-behavioral, motivational, and emotional strategies.
The sessions focus on:
* Increasing motivation to quit smoking,
* Managing cravings and withdrawal symptoms,
* Developing coping strategies for stress,
* Preventing relapse through behavioral and cognitive techniques. This program is adapted from Richmond et al. (2013) The program is based on Richmond et al. (2013) and has been further adapted for the specific context of this study and to align with current recommendations. Receives: Behavioral: Cognitive-Behavioral Therapy (CBT) for Smoking Cessation |
| Health Education Group | Active comparator | Participants in this group will receive a single-session health education program (1 hour) focused on the risks of smoking and the mechanisms of tobacco addiction. The session is conducted in a group format by a psychologist-nurse team and aims to provide participants with knowledge about the effects of smoking on health. Receives: Other: Health Education Session on Tobacco Use |
| Waitlist Control Group | No intervention | Participants in this group will not receive any intervention during the 3-month study period. They will be placed on a waitlist and will have the opportunity to participate in one of the two interventions (CBT or Health Education or both) after the study follow-up is completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Abstinence Verified by Carbon Monoxide (CO) Measurement at 1-Month Follow-Up
Smoking abstinence will be assessed through self-reported smoking status and verified by exhaled carbon monoxide (CO) levels measured using a CO monitor. Participants who self-report smoking abstinence and have a CO level below 8 parts per million (ppm) will be classified as abstinent. A CO level ≥8 ppm will indicate continued smoking.
Measured: baseline to 1-month follow-up
Smoking Abstinence Verified by Carbon Monoxide (CO) Measurement at 3-Month Follow-Up
Smoking abstinence will be assessed through self-reported smoking status and verified by exhaled carbon monoxide (CO) levels measured using a CO monitor. Participants who self-report smoking abstinence and have a CO level below 8 parts per million (ppm) will be classified as abstinent. A CO level ≥8 ppm will indicate continued smoking.
Measured: baseline to 3-month follow-up
Secondary outcomes (10)
Number of Cigarettes Smoked Per Day at 1-Month Follow-Up
The average number of cigarettes smoked per day, as self-reported by participants, will be assessed to evaluate changes in tobacco use. This outcome will be compared to baseline and between treatment groups (CBT, health education, control) at 1-month follow-up.
Measured: Baseline to 1-month follow-up
Number of Cigarettes Smoked Per Day at 3-Month Follow-Up
The average number of cigarettes smoked per day, as self-reported by participants, will be assessed to evaluate changes in tobacco use. This outcome will be compared to baseline and between treatment groups (CBT, health education, control) at 3-month follow-up.
Measured: Baseline to 3-month follow-up
Nicotine Dependence (FTND Score) at 1-Month Follow-Up
Nicotine dependence will be assessed using the Fagerström Test for Nicotine Dependence (FTND), with scores ranging from 0 (no dependence) to 10 (high dependence). Changes in scores will be compared from baseline to follow-up assessments and between treatment groups (CBT, health education, control).
Measured: Baseline to 1-month follow-up
Nicotine Dependence (FTND Score) at 3-Month Follow-Up
Nicotine dependence will be assessed using the Fagerström Test for Nicotine Dependence (FTND), with scores ranging from 0 (no dependence) to 10 (high dependence). Changes in scores will be compared from baseline to follow-up assessments and between treatment groups (CBT, health education, control).
Measured: Baseline to 3-month follow-up
Smoking Craving (FTCQ-12 Score) at 1-Month Follow-Up
Craving levels will be assessed using the French Tobacco Craving Questionnaire - 12 items (FTCQ-12), with total scores ranging from 12 (lowest craving) to 60 (highest craving). Changes in scores will be compared from baseline to follow-up assessments and between treatment groups (CBT, health education, control).
Measured: Baseline to 1-month follow-up
Smoking Craving (FTCQ-12 Score) at 3-Month Follow-Up
Craving levels will be assessed using the French Tobacco Craving Questionnaire - 12 items (FTCQ-12), with total scores ranging from 12 (lowest craving) to 60 (highest craving). Changes in scores will be compared from baseline to follow-up assessments and between treatment groups (CBT, health education, control).
Measured: Baseline to 3-month follow-up
Self-Efficacy for Smoking Cessation at 1-Month Follow-Up
Self-efficacy will be assessed using a Visual Analog Scale (VAS) ranging from 0 (not confident at all) to 10 (very confident). Changes in self-efficacy scores will be compared from baseline to follow-up assessments and between treatment groups (CBT, health education, control).
Measured: Baseline to 1-month follow-up
Self-Efficacy for Smoking Cessation at 3-Month Follow-Up
Self-efficacy will be assessed using a Visual Analog Scale (VAS) ranging from 0 (not confident at all) to 10 (very confident). Changes in self-efficacy scores will be compared from baseline to follow-up assessments and between treatment groups (CBT, health education, control).
Measured: Baseline to 3-month follow-up
Predictors of smoking abstinence at 1-month follow-up
Logistic regression will be used to examine predictors of abstinence (defined as self-reported 7-day abstinence confirmed by CO ≤ 8 ppm) at 1-month follow-up. Candidate predictors include baseline impulsivity (UPPS), anxiety and depression (HADS), nicotine dependence (FTND), education level, self-efficacy (VAS), motivation (ASSIST), ADHD symptoms (ASRS), PTSD symptoms (PCL-5), other substance use (ASSIST), and withdrawal symptoms (MNWS).
Measured: Baseline to 1 month follow-up
Predictors of smoking abstinence at 3-month follow-up
Logistic regression will be used to examine predictors of abstinence (defined as self-reported 7-day abstinence confirmed by CO ≤ 8 ppm) at 3-month follow-up. Candidate predictors include baseline impulsivity (UPPS), anxiety and depression (HADS), nicotine dependence (FTND), education level, self-efficacy (VAS), motivation (ASSIST), ADHD symptoms (ASRS), PTSD symptoms (PCL-5), other substance use (ASSIST), and withdrawal symptoms (MNWS).
Measured: Baseline to 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start18 Jun 2025
- Primary completionSep 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- 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
- Model description
- This study is a three-arm randomized controlled trial (RCT) with a parallel design. Participants are randomly assigned to one of three groups: a cognitive-behavioral therapy (CBT) intervention, a health education program, or a waitlist control group. The study aims to evaluate the efficacy of the CBT intervention in helping incarcerated individuals quit smoking, compared to a health education program and a waitlist control group.
- Masking
- None (open label)
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Collaborators
- Paris Nanterre University
- Responsible party
- Sponsor
- Investigators
- Xavier Laqueille, MD, Head of Department, Principal investigator, GHU Paris Psychiatrie et Neurosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873009
- Sponsor's protocol ID
- 24.05937.000428
- Acronym
- PriSanTabac
- Status last verified
- Feb 2025
- First submitted
- 7 Mar 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Investigators do not plan to share individual participant data (IPD) for this study. The protocol submitted to the Ethics Committee (CPP) does not include any specific provision regarding data sharing, and participants were neither informed nor consented to such use. In accordance with ethical and regulatory requirements, as well as principles of confidentiality and data protection, investigators are therefore unable to make these data available to other researchers.
Publications
Richmond R, Indig D, Butler T, Wilhelm K, Archer V, Wodak A. A randomized controlled trial of a smoking cessation intervention conducted among prisoners. Addiction. 2013 May;108(5):966-74. doi: 10.1111/add.12084. Epub 2013 Mar 11.
PubMed 23228222
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioural Therapy for Smoking Cessation in Incarcerated Men: Efficacy and Predictors of Treatment Outcomes
- ClinicalTrials.gov ID
- NCT06873009
- Acronym / sponsor ID
- PriSanTabac / 24.05937.000428
- Keywords
- Tobacco use, Smoking cessation, Cognitive Behavioral Therapy, Prisoners
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Collaborators
- Paris Nanterre University
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 12 Mar 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 goal of this clinical trial is to evaluate whether a brief group-based psychological intervention using cognitive-behavioral therapy (CBT) helps people in prison quit smoking. Researchers will compare this intervention to a health education program and a control group (waitlist) to see which approach is most effective.
The main questions this study aims to answer are:
- Does the CBT-based group intervention help more participants quit smoking compared to the health education group and the control group?
- Do participants in the CBT-based group intervention smoke fewer cigarettes per day one month after the intervention compared to the other groups?
- Do participants in the CBT-based group intervention have lower nicotine dependence ?
- What individual factors (e.g., motivation to quit, nicotine dependence, craving intensity, self-efficacy, withdrawal symptoms, anxiety, depression, ADHD, and PTSD) predict success in the CBT and Health education groups?
Participants will be randomly assigned to one of three groups:
- CBT group: Three group sessions (1.5 hours each) using CBT and motivational approaches to quitting smoking.
- Health education group: One group session (1 hour) providing information on smoking and its health risks.
- Control group: No intervention for three months (waitlist). All participants will complete an initial assessment, attend their assigned group sessions, and return for follow-up visits at 1 month and 3 months. Their smoking status will be measured through self-reports and carbon monoxide (CO) expired levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study is a three-arm randomized controlled trial (RCT) with a parallel design. Participants are randomly assigned to one of three groups: a cognitive-behavioral therapy (CBT) intervention, a health education program, or a waitlist control group. The study aims to evaluate the efficacy of the CBT intervention in helping incarcerated individuals quit smoking, compared to a health education program and a waitlist control group.
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Behavioral Therapy (CBT) group | Experimental | Behavioral: Cognitive-Behavioral Therapy (CBT) for Smoking CessationParticipants in this group will receive a cognitive-behavioral therapy (CBT)-based intervention designed to help them quit smoking. The intervention consists of three structured group sessions (1.5 hours each) over three weeks, incorporating cognitive-behavioral, motivational, and emotional strategies. The sessions focus on: * Increasing motivation to quit smoking, * Managing cravings and withdrawal symptoms, * Developing coping strategies for stress, * Preventing relapse through behavioral and cognitive techniques. This program is adapted from Richmond et al. (2013) The program is based on Richmond et al. (2013) and has been further adapted for the specific context of this study and to align with current recommendations. |
| Health Education Group | Active comparator | Other: Health Education Session on Tobacco UseParticipants in this group will receive a single-session health education program (1 hour) focused on the risks of smoking and the mechanisms of tobacco addiction. The session is conducted in a group format by a psychologist-nurse team and aims to provide participants with knowledge about the effects of smoking on health. |
| Waitlist Control Group | No intervention | –Participants in this group will not receive any intervention during the 3-month study period. They will be placed on a waitlist and will have the opportunity to participate in one of the two interventions (CBT or Health Education or both) after the study follow-up is completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male individuals currently incarcerated at Maison d'Arrêt Paris-La Santé.
- Aged 18 years or older at the time of inclusion.
- Current smoker, defined as having smoked daily in the past 30 days, or having an occasional smoking pattern of at least 5 cigarettes during the past 30 days.
- Able to speak and understand French well enough to follow the study procedures and actively participate in group sessions.
- Sentence length of at least 6 months, or if in pretrial detention, having a scheduled trial date within at least 6 months.
Key exclusion criteria (6 listed)
- Age under 18 years at the time of inclusion.
- Inability to speak and understand French well enough to follow the study procedures and actively participate in group sessions.
- Sentence length of less than 6 months, or if in pretrial detention, having a scheduled trial date in less than 6 months or no available information about the trial date.
- Severe cognitive impairment that affects comprehension and participation in the study.
- Unstable psychiatric conditions (including acute psychotic disorders, severe mood disorders, severe anxiety disorders).
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 |
|---|---|---|
| Cognitive-Behavioral Therapy (CBT) for Smoking CessationA structured three-session group intervention (1.5 hours per session over three weeks) using cognitive-behavioral and motivational strategies to enhance motivation, manage cravings, and prevent relapse. Associated Arm: CBT Group | Behavioural | Cognitive-Behavioral Therapy (CBT) group |
| Health Education Session on Tobacco UseA single-session group intervention (1 hour) providing information on the health risks of tobacco use, addiction mechanisms, and the long-term benefits of quitting smoking. Associated Arm: Health Education Group | Other | Health Education Group |
Primary outcome
Smoking Abstinence Verified by Carbon Monoxide (CO) Measurement at 1-Month Follow-Up
Time frame: baseline to 1-month follow-up
Smoking abstinence will be assessed through self-reported smoking status and verified by exhaled carbon monoxide (CO) levels measured using a CO monitor. Participants who self-report smoking abstinence and have a CO level below 8 parts per million (ppm) will be classified as abstinent. A CO level ≥8 ppm will indicate continued smoking.
Smoking Abstinence Verified by Carbon Monoxide (CO) Measurement at 3-Month Follow-Up
Time frame: baseline to 3-month follow-up
Smoking abstinence will be assessed through self-reported smoking status and verified by exhaled carbon monoxide (CO) levels measured using a CO monitor. Participants who self-report smoking abstinence and have a CO level below 8 parts per million (ppm) will be classified as abstinent. A CO level ≥8 ppm will indicate continued smoking.
10 secondary outcomes
Number of Cigarettes Smoked Per Day at 1-Month Follow-Up
Time frame: Baseline to 1-month follow-up
Number of Cigarettes Smoked Per Day at 3-Month Follow-Up
Time frame: Baseline to 3-month follow-up
Nicotine Dependence (FTND Score) at 1-Month Follow-Up
Time frame: Baseline to 1-month follow-up
Nicotine Dependence (FTND Score) at 3-Month Follow-Up
Time frame: Baseline to 3-month follow-up
Smoking Craving (FTCQ-12 Score) at 1-Month Follow-Up
Time frame: Baseline to 1-month follow-up
Smoking Craving (FTCQ-12 Score) at 3-Month Follow-Up
Time frame: Baseline to 3-month follow-up
Self-Efficacy for Smoking Cessation at 1-Month Follow-Up
Time frame: Baseline to 1-month follow-up
Self-Efficacy for Smoking Cessation at 3-Month Follow-Up
Time frame: Baseline to 3-month follow-up
Predictors of smoking abstinence at 1-month follow-up
Time frame: Baseline to 1 month follow-up
Predictors of smoking abstinence at 3-month follow-up
Time frame: Baseline to 3 month follow-up
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 3 Sep 2025.
- Background: PubMed 23228222Richmond R, Indig D, Butler T, Wilhelm K, Archer V, Wodak A. A randomized controlled trial of a smoking cessation intervention conducted among prisoners. Addiction. 2013 May;108(5):966-74. doi: 10.1111/add.12084. Epub 2013 Mar 11.
- Individual participant dataSharing planned: No. Investigators do not plan to share individual participant data (IPD) for this study. The protocol submitted to the Ethics Committee (CPP) does not include any specific provision regarding data sharing, and participants were neither informed nor consented to such use. In accordance with ethical and regulatory requirements, as well as principles of confidentiality and data protection, investigators are therefore unable to make these data available to other researchers.
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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.
Xavier Laqueille, MD, Head of Department principal investigator
GHU Paris Psychiatrie et Neurosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Therapy (CBT) for Smoking Cessation and Health Education Session on Tobacco Use in people with Tobacco Use and Smoking Cessation, run by Centre Hospitalier St Anne at 1 site in France.
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 6 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: enrolling by invitation, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
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?
Smoking Abstinence Verified by Carbon Monoxide (CO) Measurement at 1-Month Follow-Up (time frame: baseline to 1-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06873009, which also lists 1 linked publication.
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 3 Sep 2025.