Effectiveness of Combined Tobacco Treatment in Hospitalized Subjects
NCT06254001 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 134
Last updated 2024-02-23
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.
Conditions
- Tobacco Smoking
- Tobacco Withdrawal
- Nicotine Addiction
- Nicotine Withdrawal
- Nicotine Replacement Therapy
Interventions
- DRUG
-
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
Sponsors & Collaborators
-
National Institute of Respiratory Diseases, Mexico
lead OTHER_GOV
Principal Investigators
-
IRERI THIRION-ROMERO, DR · INER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-15
- Primary Completion
- 2025-01-15
- Completion
- 2026-06-15
Countries
- Mexico
Study Locations
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