Cognitive Behaviour Therapy and Nicotine Replacement to Increase Tobacco Cessation

Study Overview
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Brief Summary
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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.

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

Conditions
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Smokers

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy in group
* Drug: Nicotine replacement


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking cessation |  | 52 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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behavior cognitive therapy, Smokers, randomized clinical trial