Smoking Cessation for Patients With Acute Coronary Syndrome (ACS)

NCT ID: NCT00987597

Last Updated: 2016-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-04-30

Brief 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.

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

Keywords

Smoking; nicotine replacement; psychological behaviour; Smoking > 5 cigarettes per day; Hospitalisation for acute coronary syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

cognitive behavioural approach

specific technique of cigarette exposure and nicotinic treatment adjustment

Group Type: EXPERIMENTAL

Technique of in-vivo exposure (cigarette) and mental image exposure (craving)

Intervention Type: BEHAVIORAL

Nicotine replacement

usual approach

recommendations and nicotinic substitutes

Group Type: ACTIVE_COMPARATOR

conventional follow-up

Intervention Type: BEHAVIORAL

nicotinic substitutes

Interventions

Technique of in-vivo exposure (cigarette) and mental image exposure (craving)

Nicotine replacement

Intervention Type: BEHAVIORAL

conventional follow-up

nicotinic substitutes

Intervention Type: BEHAVIORAL

Other Intervention Names

Reduce the urge to smoke; Strategies to avoid the relapse; recommendations

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

National Cancer Institute, France

OTHER_GOV

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick HENRY, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Laurent MAGNE

Role: STUDY_DIRECTOR

Cabinet MAGNE & GALLY

Olivia GALLY

Role: STUDY_DIRECTOR

Cabinet MAGNE & GALLY

Locations

CHU Lariboisière, APHP, Cardiology

Paris, Île-de-France Region, France

Countries

France

Other Identifiers

EUDRACT : 2008-00267712

Identifier Type: -

Identifier Source: secondary_id

ID RCB : 2008-A00509-46

Identifier Type: -

Identifier Source: secondary_id

LRB0801

Identifier Type: -

Identifier Source: org_study_id