Smoking Cessation for Patients With Acute Coronary Syndrome (ACS) (PATPAC)

December 23, 2016 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile de France
      • Paris, Ile de France, France, 75010
        • CHU Lariboisière, APHP, Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cognitive behavioural approach
specific technique of cigarette exposure and nicotinic treatment adjustment
Behavioral: Technique of in-vivo exposure (cigarette) and mental image exposure (craving)
Nicotine replacement
Other Names:
  • Reduce the urge to smoke
  • Strategies to avoid the relapse
Active Comparator: usual approach
recommendations and nicotinic substitutes
Behavioral: conventional follow-up
nicotinic substitutes
Other Names:
  • recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment depending of age classes, sex, anxiety scale and other psychological characteristics
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Ministry of Health, France
National Cancer Institute, France

Investigators

  • Principal Investigator: Patrick HENRY, MD,PhD, Assistance Publique - Hôpitaux de Paris
  • Study Director: Laurent MAGNE, Cabinet MAGNE & GALLY
  • Study Director: Olivia GALLY, Cabinet MAGNE & GALLY

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

September 30, 2009

First Submitted That Met QC Criteria

September 30, 2009

First Posted (Estimate)

October 1, 2009

Study Record Updates

Last Update Posted (Estimate)

December 26, 2016

Last Update Submitted That Met QC Criteria

December 23, 2016

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LRB0801
  • EUDRACT : 2008-00267712
  • ID RCB : 2008-A00509-46

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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