Clinical trial NCT01734330: Cognitive Behaviour Therapy and Nicotine Replacement to Increase Tobacco Cessation
Official title: Efficacy of Cognitive Behaviour Therapy Associated to Nicotine Replacement in Tobacco Cessation: a Randomised Open Label Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smokers
Keywords: behavior cognitive therapy
Smokers
randomized clinical trial
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2012-11-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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;

Primary outcomes:
measure: Smoking cessation
timeFrame: 52 weeks
Secondary outcomes:
measure: Levels of anxiety
timeFrame: 6 weeks
measure: Levels of depression
timeFrame: 6 weeks
measure: Smoking Relapse rates
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Instituto de Medicina Integral Professor Fernando Figueira - IMIP
state: Pernanbuco
city: São Paulo
country: Brazil
facility: Hospital do Coração
state: SP
Study officials:
affiliation: Hospital do Coração
name: Silvia Ismael
role: STUDY_CHAIR
References: