Smoking Cessation for Patients With Acute Coronary Syndrome (ACS)

NCT00987597 — Not applicable, Completed, 144 participants, Assistance Publique - Hôpitaux de Paris

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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

RegistryNCT00987597, acronym PATPAC
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, prevention
Enrollment144 (Actual)
SponsorAssistance Publique - Hôpitaux de Paris (Other); collaborators: Ministry of Health, France, National Cancer Institute, France
ConditionsSmoking, Acute Coronary Syndrome
InterventionsTechnique of in-vivo exposure (cigarette) and mental image exposure (craving), conventional follow-up (Behavioral)
Datesstart 2008-09-01, primary completion 2009-10-01, completion 2010-04-01, first posted 2009-10-01, last updated 2016-12-26
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for Smoking All trials for Acute Coronary Syndrome All trials of Technique of in-vivo exposure (cigarette) and mental image exposure (craving) All trials of conventional follow-up

-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. 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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
cognitive behavioural approachExperimentalBehavioral: Technique of in-vivo exposure (cigarette) and mental image exposure (craving)specific technique of cigarette exposure and nicotinic treatment adjustment
usual approachActive comparatorBehavioral: conventional follow-uprecommendations and nicotinic substitutes
  • Technique of in-vivo exposure (cigarette) and mental image exposure (craving) (Behavioral), also known as Reduce the urge to smoke, Strategies to avoid the relapse: Nicotine replacement
  • conventional follow-up (Behavioral), also known as recommendations: nicotinic substitutes

+Outcome measures

Primary outcomes

  • 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). [6 month]

Secondary outcomes

  • Assessment depending of age classes, sex, anxiety scale and other psychological characteristics [6 month]

+Eligibility

Sex: All, ages: 18 Years to 70 Years

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Patient which cannot understand or read French
* Patient with possible side-effect to nicotine substitute
* Patient unaffiliated to any social security regime

+Locations (1)

FacilityCityCountryStatus
CHU Lariboisière, APHP, CardiologyParis, Île-de-France RegionFrance

+Investigators

  • 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