Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID06254001

Effectiveness of Combined Treatment of Bupropion and Nicotine Replacement Therapy in Hospitalized Subjects With Active Smoking in a Reference Center

Led by National Institute of Respiratory Diseases, Mexico · Updated on 2024-02-23

134

Participants Needed

1

Research Sites

73 weeks

Total Duration

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AI-Summary

What this Trial Is About

Tobacco smoking continues to be a leading cause of death worldwide, responsible for millions of deaths annually. This research aims to evaluate the effectiveness of combined treatments to help hospitalized active smokers maintain abstinence from smoking. The trial compares the use of nicotine replacement therapy alone versus nicotine replacement therapy combined with bupropion, alongside counseling and behavioral therapy. Participants will be randomly assigned to one of two groups: one receiving nicotine patches with counseling and cognitive behavioral therapy, and the other receiving nicotine patches plus bupropion at doses of 150 mg to 300 mg per day, along with counseling and behavioral therapy. Follow-up visits with a pulmonologist will occur at 3, 6, and 12 months, including pulmonary function tests. During the study, abstinence from smoking will be verified through urine cotinine tests and exhaled carbon monoxide tests at each follow-up. Participants will undergo regular assessments of lung function and receive behavioral support throughout the 12-month period. The main outcome measured is smoking abstinence at 12 months, confirmed by negative cotinine and exhaled carbon monoxide tests.

CONDITIONS

Brief Title

Effectiveness of Combined Tobacco Treatment in Hospitalized Subjects

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Active smokers who have consumed more than 100 cigarettes in their lifetime
  • Smoked cigarettes within the last 30 days
  • Currently hospitalized
  • Provided informed consent
Not Eligible

You will not qualify if you...

  • Used pharmacological treatment to stop smoking within the last month
  • Have contraindications for the study medications

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 12 months

Participants receive nicotine replacement therapy with counseling and cognitive behavioral therapy. Some participants also receive bupropion at doses of 150 mg to 300 mg per day in addition to nicotine replacement therapy and counseling.

Follow-up visits at 3, 6, and 12 months with a pulmonologist

Trial Site Locations

Total: 1 location

1

Instituto Nacional de Enfermedades Respiratorias

Mexico City, Mexico, 14080

Actively Recruiting

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Research Team

I

IRERI THIRION, DR

R

ROGELIO PEREZ-PADILLA, DR

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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