NCT01734330

Cognitive Behaviour Therapy and Nicotine Replacement to Increase Tobacco Cessation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Hospital do Coracao · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Smokers

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive behavioral therapy in group
DRUG	Nicotine replacement

Timeline

• Start date: 2010-07-01
• Primary completion: 2012-09-01
• Completion: 2012-11-01
• First posted: 2012-11-27
• Last updated: 2012-11-27

Locations

2 sites across 1 country: Brazil