Effectiveness of Combined Tobacco Treatment in Hospitalized Subjects

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06254001
Study type	Interventional
Source	National Institute of Respiratory Diseases, Mexico
Contact	IRERI THIRION, DR
Phone	55 5487 1700
Email	ireri.thirion@iner.gob.mx
Status	Recruiting
Phase	Phase 4
Start date	January 15, 2024
Completion date	June 15, 2026

View Details

See also
Status	Clinical Trial	Phase
Enrolling by invitation	`NCT05415371` - Persistent Poverty Counties Pregnant Women With Medicaid	N/A
Recruiting	`NCT04038255` - Mindfulness Based Smoking Cessation Among Cancer Survivors	Phase 4
Completed	`NCT04123041` - Characterize the Nicotine Uptake and Subjective Effects With Use of JUUL Electronic Nicotine Delivery Systems	N/A
Completed	`NCT02735382` - EHR-Based and Fax-Based Referral to a Tobacco Quitline: A Comparative Study	N/A
Completed	`NCT02139930` - Project 2: Strategies for Reducing Nicotine Content in Cigarettes	N/A
Completed	`NCT04107779` - Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to JUUL ENDS	N/A
Completed	`NCT05037656` - Testing a School-Based E-cigarette, Tobacco, and Betel (Areca) Nut Use Prevention Curriculum for Guam Youths	N/A
Completed	`NCT04200157` - Testing the Decoy Effect to Increase Tobacco Treatment Uptake
Enrolling by invitation	`NCT06042361` - Enhancing Equity in Smoke-free Housing	N/A
Completed	`NCT02841683` - Pragmatic Randomised Controlled Trial Evaluating Effectiveness of a Smoking Cessation e- Intervention " Tabac Info Service "	N/A
Completed	`NCT03151421` - Air Quality Feedback to Reduce Second-hand Smoke (SHS) Exposure in the Home	N/A
Completed	`NCT04104152` - CSD190203: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting	N/A
Recruiting	`NCT05306158` - Dual Use Approach Bias Training for Nicotine Addiction	N/A
Completed	`NCT04143256` - Evaluating Selected Constituents in the Exhaled Breath Samples	N/A
Completed	`NCT04094363` - CSD190202: Study to Assess Elements of Abuse Liability for Two Electronic Nicotine Delivery Systems	N/A
Completed	`NCT03553992` - An Extended Facebook Intervention for Young Sexual and Gender Minority Smokers	N/A
Completed	`NCT05102786` - CSD210904: Study to Assess Actual Use of a Heated Tobacco Product With Four Non-Combusted Cigarette Variants in Current Adult Smokers
Terminated	`NCT04396847` - Laboratory Screening of Lorcaserin for Alcohol Use Disorder	Phase 2
Completed	`NCT03694327` - Innovative Digital Therapeutic for Smoking Cessation	N/A
Completed	`NCT05030194` - Comparing Nicotine Delivery, Subjective Effects, and Sensory Experiences of Tobacco Users Using Oral Nicotine Products and Electronic Cigarettes [ZYN Study]	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.