Effectiveness of Combined Tobacco Treatment in Hospitalized Subjects

NCT06254001 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2024-02-23

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06254001 on ClinicalTrials.gov