Cognitive Behaviour Therapy and Nicotine Replacement to Increase Tobacco Cessation

November 26, 2012 updated by: Hospital do Coracao

Efficacy of Cognitive Behaviour Therapy Associated to Nicotine Replacement in Tobacco Cessation: a Randomised Open Label Clinical Trial

Background: Pharmacological strategies to improve smoking cessation have been largely studied. The efficacy of cognitive behavior therapy associated to nicotine replacement in tobacco cessation has not yet been demonstrated.

Objective: Evaluate if cognitive behavior therapy during six weeks associated to nicotine replacement for twelve weeks is able to contribute to tobacco cessation at the end of 52 weeks.

Methods: Multicentre, open-label, and pragmatic randomized controlled trial will include 334 patients. Analysis will follow intention-to-treat principle.

Patients older than 18 years old and who had smoked at least 5 cigarettes in the past year before randomization will be included.

All of them will receive nicotine replacement therapy with patches and gum. They will be randomized 1:1 ratio to attend or not cognitive behavior therapy once a week for the first six weeks of the treatment. Every two weeks all of the patients will be evaluated by a physician in order to access any adverse effects from the nicotine replacement.

All patients will have carbon monoxide levels accessed at baseline and after 6 weeks. Telephonic interview will be done at 16, 28, and 52 weeks to access the rates of tobacco cessation, relapses episodes and abstinence maintenance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

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

  • Brazil
    • Pernanbuco
      • Recife, Pernanbuco, Brazil, 50070-550
        • Instituto de Medicina Integral Professor Fernando Figueira - IMIP
    • SP
      • São Paulo, SP, Brazil, 04005000
        • Hospital do Coracao

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Smokers (≥ 5 cigarettes/day during the previous year) who had not had a period of abstinence greater than 3 months before randomization
  • Age ≥ 18 years < 75 years;
  • Capable of reading and understanding Portuguese;
  • Willing to quit smoking.

Exclusion Criteria:

  • Dementia;
  • Alcoholism;
  • Regular use of illicit drugs;
  • Panic disorders;
  • Psychosis;
  • Current pregnancy;
  • History of bipolar disturbance;
  • Contraindication to nicotine patches;
  • Prior use of bupropion and/or varenicline in the previous 12 months before randomization;
  • Patients who refused to provide informed consent;

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive behavior therapy
Cognitive behavior therapy for 6 weeks associated to nicotine replacement for 12 weeks
Behavioral: Cognitive behavioral therapy in group
Drug: Nicotine replacement
Other: Nicotine replacement
Nicotine replacement for 12 weeks
Drug: Nicotine replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Smoking cessation
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of anxiety
Time Frame: 6 weeks
Evaluated by the State-Trait Anxiety Inventory
6 weeks
Levels of depression
Time Frame: 6 weeks
Evaluated by Beck Depression Inventory
6 weeks
Smoking Relapse rates
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

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

Sponsor

Hospital do Coracao

Collaborators

Ministry of Health, Brazil

Investigators

  • Study Chair: Silvia Ismael, Hospital do Coracao

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

July 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

November 22, 2012

First Submitted That Met QC Criteria

November 26, 2012

First Posted (Estimate)

November 27, 2012

Study Record Updates

Last Update Posted (Estimate)

November 27, 2012

Last Update Submitted That Met QC Criteria

November 26, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 119/2010

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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