Cognitive Behaviour Therapy and Nicotine Replacement to Increase Tobacco Cessation

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.

Timeline

Start

2010-07

Primary completion

2012-09

Completion

2012-11

Drugs

Indications

No indication recorded.