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OpenTrials
Completed

NCT Number: NCT01734330

Cognitive Behaviour Therapy and Nicotine Replacement to Increase Tobacco Cessation

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.

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Key information

Conditions

Smokers

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Medicina Integral Professor Fernando Figueira - IMIP, Recife, Pernanbuco, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Cognitive behavioral therapy in group

Behavioral

Nicotine Replacement

Drug

Primary outcomes

  1. Smoking cessation

    Time frame: 52 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital do Coracao

Other

Collaborators

  • Ministry of Health, Brazil

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 27, 2012
Registry last updated
Nov 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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