Smokers Clinical Trial
Official title:
Efficacy of Cognitive Behaviour Therapy Associated to Nicotine Replacement in Tobacco Cessation: a Randomised Open Label Clinical Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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