Effectiveness of Combined Treatment of Bupropion and Nicotine Replacement Therapy in Hospitalized Subjects With Active Smoking in a Reference Center

C80-23

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.

2024-01-15

2025-01-15

2026-06-15

Recruiting

Early phase I

134

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%.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups:\n\n1. Nicotine replacement therapy\n2. Nicotine replacement therapy and bupropion', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 134, 'type': 'ESTIMATED'}}

2024-02-23