Overview
In the 20th century, tobacco caused the death of 100 million people worldwide and it is estimated that it will be responsible for 1 billion deaths in the 21st century[1]. Currently 8 million people die each year from smoking, 7 million are associated with active smoking [2], thus being the main risk factor for loss of disability-adjusted life years for men and the ninth most important risk factor for women[2]. In previous studies it has been reported that approximately 21% (14%-30%) of subjects who have required hospitalization are active smokers, being higher in men than in women (28% vs 14%). The initiation of treatment for smoking cessation in this group of subjects has shown an effectiveness rate of up to 65% to maintain abstinence 6 to 12 months after discharge[3]. The effectiveness has been analyzed in scenarios with only brief advice, in some others with the use of medications such as varenicline, bupropion and nicotine replacement therapy, however, the interventions have not been standardized for adequate analysis, which could contribute to the different results[4].
Description
Our objective is to know the effectiveness of combined treatment to maintain abstinence in subjects with active smoking who are hospitalized in a reference center.
Bupropion and nicotine replacement therapy are the drugs used in this clinical trial.
Subjects will be randomly assigned to two groups: nicotine replacement therapy or nicotine replacement therapy plus bupropion. All subjects will have counseling, conductive behavioral therapy, follow-up at 3, 6 and 12 months with a pulmonologist. Pulmonary function tests will be performed every 3, 6, and 12 months. Abstinence will be corroborated with a cotinine (urine) test and an exhaled carbon monoxide test.
Eligibility
Inclusion Criteria:
>18 years Active smokers (consumption of more than 100 cigarettes in their entire life, and
who have consumed cigarettes in the last 30 days) Hospitalized subjects Informed consent
Exclusion Criteria:
- Subjects who have had pharmacological treatment to stop smoking in the last month
- Subjects with contraindications for medications.
Sample size calculation, 80% power, unilateral, due to difference in proportions, estimated
loss of 25%.