Cognitive Behaviour Therapy and Nicotine Replacement to Increase Tobacco Cessation

Not Applicable

Completed

• Conditions: Smokers
• Interventions: Behavioral: Cognitive behavioral therapy in group; Drug: Nicotine replacement

• Registration Number: NCT01734330
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2012-09
• Status Verified: 2012-11
• Study Completion: 2012-11
• Study First Submitted: 2012-11-22
• Study First Submitted QC: 2012-11-26
• Last Update Submitted: 2012-11-26
• Study First Posted: 2012-11-27
• Last Update Posted: 2012-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive behavior therapy	Cognitive behavioral therapy in group	Cognitive behavior therapy for 6 weeks associated to nicotine replacement for 12 weeks
Cognitive behavior therapy	Nicotine replacement	Cognitive behavior therapy for 6 weeks associated to nicotine replacement for 12 weeks
Nicotine replacement	Nicotine replacement	Nicotine replacement for 12 weeks

Primary Outcome Measures

Name	Time	Method
Smoking cessation	52 weeks

Secondary Outcome Measures

Name	Time	Method
Levels of anxiety	6 weeks	Evaluated by the State-Trait Anxiety Inventory
Levels of depression	6 weeks	Evaluated by Beck Depression Inventory
Smoking Relapse rates	52 weeks

Trial Locations

Locations (2)

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

Hospital do Coração; 🇧🇷 São Paulo, SP, Brazil