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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01734330
Other study ID # 119/2010
Secondary ID
Status Completed
Phase N/A
First received November 22, 2012
Last updated November 26, 2012
Start date July 2010
Est. completion date November 2012

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Cognitive behavioral therapy in group

Drug:
Nicotine replacement


Locations

Country Name City State
Brazil Instituto de Medicina Integral Professor Fernando Figueira - IMIP Recife Pernanbuco
Brazil Hospital do Coração São Paulo SP

Sponsors (2)

Lead Sponsor Collaborator
Hospital do Coracao Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

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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