Clinical trial NCT06254001: Effectiveness of Combined Tobacco Treatment in Hospitalized Subjects
Official title: Effectiveness of Combined Treatment of Bupropion and Nicotine Replacement Therapy in Hospitalized Subjects With Active Smoking in a Reference Center
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Tobacco Smoking
Tobacco Withdrawal
Nicotine Addiction
Nicotine Withdrawal
Nicotine Replacement Therapy
Keywords: tobacco
bupropion
nicotine replacement therapy
abstinence
Lead sponsor: National Institute of Respiratory Diseases, Mexico
Sponsor class: OTHER_GOV
First posted: 2024-02-12
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups:

1. Nicotine replacement therapy
2. Nicotine replacement therapy and bupropion
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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%.

Primary outcomes:
measure: Abstinence at 12 months. Negative cotinine test and negative an exhaled carbon monoxide test
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ciudad de mexico
country: Mexico
facility: Instituto Nacional de Enfermedades Respiratorias
Study officials:
affiliation: INER
name: IRERI THIRION-ROMERO, DR
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.