Cognitive Behaviour Therapy and Nicotine Replacement to Increase Tobacco Cessation

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital do Coracao
• Collaborator: Ministry of Health, Brazil
• Treatments: Nicotine

Criteria

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;