Effectiveness of combined tobacco treatment for hospitalized smokers
Effectiveness of Combined Treatment of Bupropion and Nicotine Replacement Therapy in Hospitalized Subjects With Active Smoking in a Reference Center
This study is testing if a combination of nicotine replacement therapy and bupropion, along with counseling, can help hospitalized smokers quit smoking more effectively than just using nicotine replacement therapy alone.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institute of Respiratory Diseases, Mexico Government |
| Locations | 1 site (Mexico City) |
| Trial ID | NCT06254001 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a combined treatment approach for smoking cessation in hospitalized patients. Participants will be randomly assigned to receive either nicotine replacement therapy alone or in combination with bupropion, alongside counseling and behavioral therapy. Follow-up assessments will occur at 3, 6, and 12 months, including pulmonary function tests and verification of abstinence through urine cotinine and exhaled carbon monoxide tests. The study seeks to standardize interventions for this high-risk group to improve smoking cessation outcomes.
Who should consider this trial
Good fit: Ideal candidates are hospitalized adults over 18 years old who are active smokers and have not received pharmacological treatment for smoking cessation in the past month.
Not a fit: Patients who have contraindications for the medications used in the trial or who have recently undergone pharmacological treatment for smoking cessation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance smoking cessation rates among hospitalized patients, leading to improved health outcomes.
How similar studies have performed: Previous studies have shown varying effectiveness of smoking cessation interventions in hospitalized patients, but this combined approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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%.
Where this trial is running
Mexico City
- Instituto Nacional de Enfermedades Respiratorias — Mexico City, Mexico (Recruiting)
Study contacts
- Principal investigator: Ireri Thirion-Romero, Dr — Iner
- Study coordinator: Ireri Thirion, Dr
- Email: ireri.thirion@iner.gob.mx
- Phone: 55 5487 1700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.