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Effectiveness of Combined Treatment of Bupropion and Nicotine Replacement Therapy in Hospitalized Subjects With Active Smoking in a Reference Center
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. Currently 8 million people die each year from smoking, 7 million are associated with active smoking, thus being the main risk factor for loss of disability-adjusted life years for men and the ninth most important risk factor for women. 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. 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.
The objective is to know the effectiveness of combined treatment to maintain abstinence in participants with active smoking who are hospitalized in a reference center. Bupropion and nicotine replacement therapy are the drugs used in this clinical trial. Participants will be randomly assigned to two groups: nicotine replacement therapy or nicotine replacement therapy plus bupropion. All participants 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Instituto Nacional de Enfermedades Respiratorias
Mexico City, Mexico
Start Date
January 15, 2024
Primary Completion Date
January 15, 2025
Completion Date
June 15, 2026
Last Updated
February 23, 2024
134
ESTIMATED participants
Bupropion
DRUG
Nicotine replacement therapy (Nicotine patches)
DRUG
Lead Sponsor
National Institute of Respiratory Diseases, Mexico
NCT07236580
NCT06798324
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06218056