Cognitive Behaviour Therapy and Nicotine Replacement to Increase Tobacco Cessation

Smokers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01734330
• Other study ID #: 119/2010
• Status: Completed
• Phase: N/A
• First received: November 22, 2012
• Last updated: November 26, 2012
• Start date: July 2010
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smokers

Intervention

Behavioral:
• Cognitive behavioral therapy in group

Drug:
• Nicotine replacement

Locations

Country	Name	City	State
Brazil	Instituto de Medicina Integral Professor Fernando Figueira - IMIP	Recife	Pernanbuco
Brazil	Hospital do Coração	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Hospital do Coracao	Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking cessation		52 weeks	No
Secondary	Levels of anxiety	Evaluated by the State-Trait Anxiety Inventory	6 weeks	No
Secondary	Levels of depression	Evaluated by Beck Depression Inventory	6 weeks	No
Secondary	Smoking Relapse rates		52 weeks	No