NCT06254001

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: National Institute of Respiratory Diseases, Mexico · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Tobacco Smoking
• Tobacco Withdrawal
• Nicotine Addiction
• Nicotine Withdrawal
• Nicotine Replacement Therapy

Interventions

Type	Name	Description
DRUG	Bupropion	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
DRUG	Nicotine replacement therapy (Nicotine patches)	Nicotine replacement therapy (Nicotine patches) plus counseling and cognitive behavioral therapy

Timeline

• Start date: 2024-01-15
• Primary completion: 2025-01-15
• Completion: 2026-06-15
• First posted: 2024-02-12
• Last updated: 2024-02-23

Locations

1 site across 1 country: Mexico