Effectiveness of Combined Tobacco Treatment in Hospitalized Subjects

Tobacco Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06254001
• Other study ID #: C80-23
• Status: Recruiting
• Phase: Phase 4
• Start date: January 15, 2024
• Est. completion date: June 15, 2026

Study information

• Verified date: February 2024
• Source: National Institute of Respiratory Diseases, Mexico
• Contact: IRERI THIRION, DR
• Phone: 55 5487 1700
• Email: ireri.thirion[@]iner.gob.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: June 15, 2026
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%.

Related Conditions & MeSH terms

• Nicotine Addiction
• Nicotine Replacement Therapy
• Nicotine Withdrawal
• Tobacco Smoking
• Tobacco Use Disorder
• Tobacco Withdrawal

Intervention

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

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Enfermedades Respiratorias	Ciudad de mexico

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Respiratory Diseases, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

Makate M, Whetton S, Tait RJ, Dey T, Scollo M, Banks E, Norman R, Pidd K, Roche AM, Allsop S. Tobacco Cost of Illness Studies: A Systematic Review. Nicotine Tob Res. 2020 Apr 17;22(4):458-465. doi: 10.1093/ntr/ntz038. — View Citation

Martinez C, Fu M, Castellano Y, Riccobene A, Fernandez P, Cabrera S, Gavilan E, Feliu A, Puig-Llobet M, Fuster P, Martinez-Sanchez JM, Montes J, Estrada JM, Moreno C, Falco-Pegueroles A, Galimany J, Brando C, Suner-Soler R, Capsada A, Fernandez E; y Grupo de Coordinadores de la Red Catalana de Hospitales sin Humo (XCHsF). Smoking among hospitalized patients: A multi-hospital cross-sectional study of a widely neglected problem. Tob Induc Dis. 2018 Jul 30;16:34. doi: 10.18332/tid/92927. eCollection 2018. — View Citation

Rigotti NA, Clair C, Munafo MR, Stead LF. Interventions for smoking cessation in hospitalised patients. Cochrane Database Syst Rev. 2012 May 16;5(5):CD001837. doi: 10.1002/14651858.CD001837.pub3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abstinence at 12 months. Negative cotinine test and negative an exhaled carbon monoxide test	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

External Links

•   Tobacco Control is an international peer-reviewed journal covering the nature and consequences of tobacco use worldwide