Effectiveness of Combined Tobacco Treatment in Hospitalized Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2026-06-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tobacco Smoking Tobacco Withdrawal Nicotine Addiction Nicotine Withdrawal Nicotine Replacement Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups:

1. Nicotine replacement therapy
2. Nicotine replacement therapy and bupropion

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nicotine replacement therapy

Nicotine replacement therapy (Nicotine patches) plus counseling and cognitive behavioral therapy

Group Type ACTIVE_COMPARATOR

Nicotine replacement therapy (Nicotine patches)

Intervention Type DRUG

Nicotine replacement therapy (Nicotine patches) plus counseling and cognitive behavioral therapy

Nicotine replacement therapy and Bupropion

Nicotine replacement therapy (Nicotine patches) plus Bupropion and counseling and cognitive behavioral therapy

Group Type EXPERIMENTAL

Bupropion

Intervention Type DRUG

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

Nicotine replacement therapy (Nicotine patches)

Intervention Type DRUG

Nicotine replacement therapy (Nicotine patches) plus counseling and cognitive behavioral therapy

Interventions

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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

Intervention Type DRUG

Nicotine replacement therapy (Nicotine patches)

Nicotine replacement therapy (Nicotine patches) plus counseling and cognitive behavioral therapy

Intervention Type DRUG

Eligibility Criteria

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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%.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No