RecruitingPhase 4NCT06254001

Effectiveness of Combined Tobacco Treatment in Hospitalized Subjects

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


Sponsor

National Institute of Respiratory Diseases, Mexico

Enrollment

134 participants

Start Date

Jan 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • \>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 Criteria3

  • 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%.

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Interventions

DRUGBupropion

Bupropion will be added at doses of 150 mg to 300 mg per day in addition to nicotine replacement therapy, counseling and cognitive behavioral therapy

DRUGNicotine replacement therapy (Nicotine patches)

Nicotine replacement therapy (Nicotine patches) plus counseling and cognitive behavioral therapy


Locations(1)

Instituto Nacional de Enfermedades Respiratorias

Mexico City, Mexico

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NCT06254001


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