Effectiveness of Combined Tobacco Treatment in Hospitalized Subjects

NCT06254001 | Recruiting Phase 4 DMC

• 1 other identifier: C80-23
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

tobacco; bupropion; nicotine replacement therapy; abstinence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Nicotine replacement therapy

ACTIVE COMPARATOR

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

Drug: Nicotine replacement therapy (Nicotine patches)

Nicotine replacement therapy and Bupropion

EXPERIMENTAL

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

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

Interventions

Bupropion 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 and Bupropion

Nicotine replacement therapy (Nicotine patches) DRUG

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

Nicotine replacement therapy; Nicotine replacement therapy and Bupropion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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%.

Sponsors & Collaborators

• National Institute of Respiratory Diseases, Mexico: lead

Study Sites (1)

Instituto Nacional de Enfermedades Respiratorias

Mexico City, 14080, Mexico

RECRUITING

Related Publications (3)

• 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.

  PMID: 31516433 BACKGROUND

• 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.

  PMID: 22592676 BACKGROUND

• 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.

  PMID: 30874290 RESULT

Related Links

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

MeSH Terms

Conditions

Tobacco Smoking; Tobacco Use Disorder

Interventions

Bupropion; Nicotine Replacement Therapy; Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Drug Therapy; Therapeutics

Study Officials

• IRERI THIRION-ROMERO, DR

  INER

  PRINCIPAL INVESTIGATOR

Central Study Contacts

IRERI THIRION, DR

CONTACT

55 5487 1700; ireri.thirion@iner.gob.mx

ROGELIO PEREZ-PADILLA, DR

CONTACT

55 5487 1700; perezpad@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two groups: 1. Nicotine replacement therapy 2. Nicotine replacement therapy and bupropion

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: January 15, 2024
• Primary Completion: January 15, 2025
• Study Completion (Estimated): June 15, 2026
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

ME (1)