MedDataX Logo

Cognitive Behaviour Therapy and Nicotine Replacement to Increase Tobacco Cessation

NCT ID: NCT01734330

Last Updated: 2012-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smokers

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

behavior cognitive therapy Smokers randomized clinical trial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cognitive behavior therapy

Cognitive behavior therapy for 6 weeks associated to nicotine replacement for 12 weeks

Group Type EXPERIMENTAL

Cognitive behavioral therapy in group

Intervention Type BEHAVIORAL

Nicotine replacement

Intervention Type DRUG

Nicotine replacement

Nicotine replacement for 12 weeks

Group Type OTHER

Nicotine replacement

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cognitive behavioral therapy in group

Intervention Type BEHAVIORAL

Nicotine replacement

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ministry of Health, Brazil

OTHER_GOV

Sponsor Role collaborator

Hospital do Coracao

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Silvia Ismael

Role: STUDY_CHAIR

Hospital do Coração

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Instituto de Medicina Integral Professor Fernando Figueira - IMIP

Recife, Pernanbuco, Brazil

Site Status

Hospital do Coração

São Paulo, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

119/2010

Identifier Type: -

Identifier Source: org_study_id