Effectiveness of Combined Tobacco Treatment in Hospitalized Subjects

National Institute of Respiratory Diseases, Mexico

Status and phase: Enrolling; Phase 4

Conditions: Nicotine Addiction; Tobacco Smoking; Nicotine Withdrawal; Nicotine Replacement Therapy; Tobacco Withdrawal

Treatments: Drug: Nicotine replacement therapy (Nicotine patches); Drug: Bupropion

Study type: Interventional

Funder types: Other

Identifiers

NCT06254001

C80-23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

Nicotine replacement therapy

Active Comparator group

Description:

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

Treatment:

Drug: Nicotine replacement therapy (Nicotine patches)

Nicotine replacement therapy and Bupropion

Experimental group

Description:

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

Treatment:

Drug: Bupropion

Drug: Nicotine replacement therapy (Nicotine patches)