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Cognitive Behaviour Therapy and Nicotine Replacement to Increase Tobacco Cessation

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ClinicalTrials.gov Identifier: NCT01734330
Recruitment Status : Completed
First Posted : November 27, 2012
Last Update Posted : November 27, 2012
Ministry of Health, Brazil
Information provided by (Responsible Party):
Hospital do Coracao

Brief Summary:

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.

Condition or disease Intervention/treatment
Smokers Behavioral: Cognitive behavioral therapy in group Drug: Nicotine replacement

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Cognitive Behaviour Therapy Associated to Nicotine Replacement in Tobacco Cessation: a Randomised Open Label Clinical Trial
Study Start Date : July 2010
Primary Completion Date : September 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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
Nicotine replacement
Nicotine replacement for 12 weeks
Drug: Nicotine replacement

Primary Outcome Measures :
  1. Smoking cessation [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Levels of anxiety [ Time Frame: 6 weeks ]
    Evaluated by the State-Trait Anxiety Inventory

  2. Levels of depression [ Time Frame: 6 weeks ]
    Evaluated by Beck Depression Inventory

  3. Smoking Relapse rates [ Time Frame: 52 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734330

Instituto de Medicina Integral Professor Fernando Figueira - IMIP
Recife, Pernanbuco, Brazil, 50070-550
Hospital do Coração
São Paulo, SP, Brazil, 04005000
Sponsors and Collaborators
Hospital do Coracao
Ministry of Health, Brazil
Study Chair: Silvia Ismael Hospital do Coração

Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT01734330     History of Changes
Other Study ID Numbers: 119/2010
First Posted: November 27, 2012    Key Record Dates
Last Update Posted: November 27, 2012
Last Verified: November 2012

Keywords provided by Hospital do Coracao:
behavior cognitive therapy
randomized clinical trial

Additional relevant MeSH terms:
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action