Cognitive Behaviour Therapy and Nicotine Replacement to Increase Tobacco Cessation
|ClinicalTrials.gov Identifier: NCT01734330|
Recruitment Status : Completed
First Posted : November 27, 2012
Last Update Posted : November 27, 2012
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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 for 12 weeks
|Drug: Nicotine replacement|
- Smoking cessation [ Time Frame: 52 weeks ]
- Levels of anxiety [ Time Frame: 6 weeks ]Evaluated by the State-Trait Anxiety Inventory
- Levels of depression [ Time Frame: 6 weeks ]Evaluated by Beck Depression Inventory
- Smoking Relapse rates [ Time Frame: 52 weeks ]
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|
|Study Chair:||Silvia Ismael||Hospital do Coração|