SmokingPATPACNCT00987597
Smoking Cessation for Patients With Acute Coronary Syndrome (ACS)
A study testing Technique of in-vivo exposure (cigarette) and mental image exposure (craving) and conventional follow-up in people with Smoking and Acute Coronary Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of the present study is to assess if a personal care program of smokers hospitalised for acute coronary syndrome can change the smoking habits as compared with similar patients in conventional care program at 6 months. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Smoking, Acute Coronary Syndrome
- What is being tested?
- Technique of in-vivo exposure (cigarette) and mental image exposure (craving) and conventional follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2008to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are men and women of less than 70 years old
- Hospitalised for acute coronary syndrome in cardiology Intensive Care Unit
- Active smoking >5 cigarettes/day
- Has given consent to participate in the study and haven't expressed its opposition the exploitation of data as part of the study
Who cannot join
- Presence of another dependence : alcohol abuse avowed or strongly suspected, addiction to drugs, high dose benzodiazepine dependence. clinical assessment
- Major psychiatric disorders or history. clinical assessment
- Treatment with lithium and neuroleptic. clinical assessment
- Patient whose cardiac problem could lead to hemodynamic instability during 48 h after admission.
- Patient scheduled for programmed hospitalisation within 6 months after release from hospital (>3 days long, including coronary bypass)
- Patients presenting another severe pathology requiring 6 months specific treatments. clinical assessment
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- Patient which cannot understand or read French
- Patient with possible side-effect to nicotine substitute
- Patient unaffiliated to any social security regime
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Lariboisière, APHP, Cardiology
Paris, Île-de-France Region, 75010
About this study
Official title: Effectiveness of a Managed Care Smoking Cessation Program in Patients With Acute Coronary Syndrome Based on Nicotine Replacement as a Treatment and a Cognitive-behavioral Approach
The aim of the present study is to assess if a personal care program of smokers hospitalised for acute coronary syndrome can change the smoking habits as compared with similar patients in conventional care program at 6 months. The program includes a cognitive-behavioural approach associated with a nicotine replacement treatment presented as an obligatory non optional treatment. Patients are men and women of less than 70 years old hospitalised for acute coronary syndrome. Major exclusion criteria is the presence of another dependence. The program includes a cognitive-behavioural approach based on the specific technique of "exposure" and the prescription of nicotine patch considered as other usual cardiologic treatments for at least 6 months. The end point is the smoking habits at 6 months classified as: no smoking confirmed by CO measurement, smoking or doubtful (declaration of no smoking by the patient but a CO level > 10 ppm). 72 patients in each group will be included in 2 majors sites.
Read the detailed description
The cognitive behavioural approach group : This group will receive an inclusion visit at first, then two "cigaret exposures cessions" during hospitalisation. Thereafter-one week after he's out- the patient will come for 5 follow up visits consisting in the specific technique of cigaret exposure and nicotinic treatment adjustment. Then the last visit, at six months, will tell us if the patient is an effective non smoker or not; We'll be also collecting psychological and medical informations (such as the treatment, IMC, cardiovascular check up and psychological tests). The control group : This group is managed as "usual" : the nurse gives very rapid recommendations to the patients concerning smoking cessation. Nicotinic substitutes are proposed to the patients but the patient must find them by itself.
- Conditions
- Smoking, Acute Coronary Syndrome
- Being tested
- Technique of in-vivo exposure (cigarette) and mental image exposure (craving), conventional follow-up
- Keywords
- Smoking, nicotine replacement, psychological behaviour, Smoking > 5 cigarettes per day, Hospitalisation for acute coronary syndrome
- Medical subject headings
- Smoking, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technique of in-vivo exposure (cigarette) and mental image exposure (craving)Behavioural
Also called Reduce the urge to smoke, Strategies to avoid the relapse
Nicotine replacement
conventional follow-upBehavioural
Also called recommendations
nicotinic substitutes
| Study group | Role | What they receive |
|---|---|---|
| cognitive behavioural approach | Experimental | specific technique of cigarette exposure and nicotinic treatment adjustment Receives: Behavioral: Technique of in-vivo exposure (cigarette) and mental image exposure (craving) |
| usual approach | Active comparator | recommendations and nicotinic substitutes Receives: Behavioral: conventional follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
The smoking habits at 6 months classified as : no smoking confirmed by CO measurement, smoking or doubtful (declaration of no smoking by the patient but a CO level > 10 ppm).
Measured: 6 month
Secondary outcomes (1)
Assessment depending of age classes, sex, anxiety scale and other psychological characteristics
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startSep 2008
- Primary completionOct 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Patrick HENRY, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisLaurent MAGNE, Study director, Cabinet MAGNE & GALLYOlivia GALLY, Study director, Cabinet MAGNE & GALLY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987597
- Sponsor's protocol ID
- LRB0801
- Other IDs
- EUDRACT : 2008-00267712, ID RCB : 2008-A00509-46
- Acronym
- PATPAC
- Status last verified
- Nov 2013
- First submitted
- 30 Sep 2009
- Last updated
- 26 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Managed Care Smoking Cessation Program in Patients With Acute Coronary Syndrome Based on Nicotine Replacement as a Treatment and a Cognitive-behavioral Approach
- ClinicalTrials.gov ID
- NCT00987597
- Acronym / sponsor ID
- PATPAC / LRB0801
- Conditions
- Smoking, Acute Coronary Syndrome
- Keywords
- Smoking, nicotine replacement, psychological behaviour, Smoking > 5 cigarettes per day, Hospitalisation for acute coronary syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France, National Cancer Institute, France
- Study start
- Sep 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 1 Oct 2009 (estimated)
- 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 aim of the present study is to assess if a personal care program of smokers hospitalised for acute coronary syndrome can change the smoking habits as compared with similar patients in conventional care program at 6 months. The program includes a cognitive-behavioural approach associated with a nicotine replacement treatment presented as an obligatory non optional treatment. Patients are men and women of less than 70 years old hospitalised for acute coronary syndrome. Major exclusion criteria is the presence of another dependence. The program includes a cognitive-behavioural approach based on the specific technique of "exposure" and the prescription of nicotine patch considered as other usual cardiologic treatments for at least 6 months. The end point is the smoking habits at 6 months classified as: no smoking confirmed by CO measurement, smoking or doubtful (declaration of no smoking by the patient but a CO level > 10 ppm). 72 patients in each group will be included in 2 majors sites.
Detailed description
The cognitive behavioural approach group : This group will receive an inclusion visit at first, then two "cigaret exposures cessions" during hospitalisation. Thereafter-one week after he's out- the patient will come for 5 follow up visits consisting in the specific technique of cigaret exposure and nicotinic treatment adjustment. Then the last visit, at six months, will tell us if the patient is an effective non smoker or not; We'll be also collecting psychological and medical informations (such as the treatment, IMC, cardiovascular check up and psychological tests). The control group : This group is managed as "usual" : the nurse gives very rapid recommendations to the patients concerning smoking cessation. Nicotinic substitutes are proposed to the patients but the patient must find them by itself.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cognitive behavioural approach | Experimental | Behavioral: Technique of in-vivo exposure (cigarette) and mental image exposure (craving)specific technique of cigarette exposure and nicotinic treatment adjustment |
| usual approach | Active comparator | Behavioral: conventional follow-uprecommendations and nicotinic substitutes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients are men and women of less than 70 years old
- Hospitalised for acute coronary syndrome in cardiology Intensive Care Unit
- Active smoking >5 cigarettes/day
- Has given consent to participate in the study and haven't expressed its opposition the exploitation of data as part of the study
Key exclusion criteria (9 listed)
- Presence of another dependence : alcohol abuse avowed or strongly suspected, addiction to drugs, high dose benzodiazepine dependence. clinical assessment
- Major psychiatric disorders or history. clinical assessment
- Treatment with lithium and neuroleptic. clinical assessment
- Patient whose cardiac problem could lead to hemodynamic instability during 48 h after admission.
- Patient scheduled for programmed hospitalisation within 6 months after release from hospital (>3 days long, including coronary bypass)
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 |
|---|---|---|
| Technique of in-vivo exposure (cigarette) and mental image exposure (craving)Also: Reduce the urge to smoke, Strategies to avoid the relapseNicotine replacement | Behavioural | cognitive behavioural approach |
| conventional follow-upAlso: recommendationsnicotinic substitutes | Behavioural | usual approach |
Primary outcome
The smoking habits at 6 months classified as : no smoking confirmed by CO measurement, smoking or doubtful (declaration of no smoking by the patient but a CO level > 10 ppm).
Time frame: 6 month
1 secondary outcome
Assessment depending of age classes, sex, anxiety scale and other psychological characteristics
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2016.
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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. This study is not recruiting at the moment.
Patrick HENRY, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Laurent MAGNE study director
Cabinet MAGNE & GALLY
Olivia GALLY study director
Cabinet MAGNE & GALLY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technique of in-vivo exposure (cigarette) and mental image exposure (craving) and conventional follow-up in people with Smoking and Acute Coronary Syndrome, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 26 Dec 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The smoking habits at 6 months classified as : no smoking confirmed by CO measurement, smoking or doubtful (declaration of no smoking by the patient but a CO level > 10 ppm). (time frame: 6 month). 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 26 Dec 2016.