Effectiveness of Combined Tobacco Treatment in Hospitalized Subjects

February 21, 2024 updated by: Ireri Thirion Romero, National Institute of Respiratory Diseases, Mexico

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Estimated)

134

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
      • Ciudad de mexico, Mexico, 14080
        • Recruiting
        • Instituto Nacional De Enfermedades Respiratorias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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%.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nicotine replacement therapy
Nicotine replacement therapy (Nicotine patches) plus counseling and cognitive behavioral therapy
Drug: Nicotine replacement therapy (Nicotine patches)
Nicotine replacement therapy (Nicotine patches) plus counseling and cognitive behavioral therapy
Experimental: Nicotine replacement therapy and Bupropion
Nicotine replacement therapy (Nicotine patches) plus Bupropion and counseling and cognitive behavioral therapy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abstinence at 12 months. Negative cotinine test and negative an exhaled carbon monoxide test
Time Frame: 12 months
Abstinence will be corroborated with a cotinine test and an exhaled carbon monoxide test. Negative urine cotinine test and an exhaled carbon monoxide test less than 6 ppb.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Respiratory Diseases, Mexico

Investigators

  • Principal Investigator: IRERI THIRION-ROMERO, DR, INER

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Estimated)

January 15, 2025

Study Completion (Estimated)

June 15, 2026

Study Registration Dates

First Submitted

February 2, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C80-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be collected on the redCap platform, and may be shared in Excel CSV format as well as related dictionaries. SAP, ICF, CSR information will be shared after the results are published.

IPD Sharing Time Frame

The IPD data will be available when the study is published in December 2026 and will remain for an additional year until December 2027.

IPD Sharing Access Criteria

The information may be requested by researchers who wish to carry out meta-analysis or researchers related to the area of secondary prevention of smoking. They may request it from the main or corresponding author who will review the applications.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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