Smokers Clinical Trial
Official title:
Efficacy of Cognitive Behaviour Therapy Associated to Nicotine Replacement in Tobacco Cessation: a Randomised Open Label Clinical Trial
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 |
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.
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; |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Instituto de Medicina Integral Professor Fernando Figueira - IMIP | Recife | Pernanbuco |
Brazil | Hospital do Coração | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Hospital do Coracao | Ministry of Health, Brazil |
Brazil,
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 |
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