Tobacco SmokingPhase 4NCT06254001
Effectiveness of Combined Tobacco Treatment in Hospitalized Subjects
A Phase 4 study testing Bupropion and Nicotine replacement therapy (Nicotine patches) in people with Tobacco Smoking and Tobacco Withdrawal, run by National Institute of Respiratory Diseases, Mexico at 1 site in Mexico.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Smoking, Tobacco Withdrawal, Nicotine Addiction
- What is being tested?
- Bupropion and Nicotine replacement therapy (Nicotine patches)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteMexico
- Study dates
- 15 Jan 2024to 15 Jun 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Enfermedades Respiratorias
Mexico City, 14080
About this study
Official title: Effectiveness of Combined Treatment of Bupropion and Nicotine Replacement Therapy in Hospitalized Subjects With Active Smoking in a Reference Center
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.
Read the 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.
- Conditions
- Tobacco Smoking, Tobacco Withdrawal, Nicotine Addiction, Nicotine Withdrawal, Nicotine Replacement Therapy
- Being tested
- Bupropion, Nicotine replacement therapy (Nicotine patches)
- Keywords
- tobacco, bupropion, nicotine replacement therapy, abstinence
- Medical subject headings
- Tobacco Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
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)Drug
Nicotine replacement therapy (Nicotine patches) plus counseling and cognitive behavioral therapy
| Study group | Role | What they receive |
|---|---|---|
| Nicotine replacement therapy | Active comparator | Nicotine replacement therapy (Nicotine patches) plus counseling and cognitive behavioral therapy Receives: 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 Receives: Drug: Bupropion; Drug: Nicotine replacement therapy (Nicotine patches) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start15 Jan 2024
- Primary completion15 Jan 2025 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups: 1. Nicotine replacement therapy 2. Nicotine replacement therapy and bupropion
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Respiratory Diseases, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ireri Thirion Romero, National Institute of Respiratory Diseases, Mexico
- Investigators
- IRERI THIRION-ROMERO, DR, Principal investigator, INER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254001
- Sponsor's protocol ID
- C80-23
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be collected on the redCap platform, and may be shared in Excel CSV format as well as related dictionaries. SAP, ICF, CSR information will be shared after the results are published.
Publications
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.
PubMed 31516433Rigotti 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.
PubMed 22592676Makate 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.
PubMed 30874290
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Combined Treatment of Bupropion and Nicotine Replacement Therapy in Hospitalized Subjects With Active Smoking in a Reference Center
- ClinicalTrials.gov ID
- NCT06254001
- Acronym / sponsor ID
- C80-23
- Conditions
- Tobacco Smoking, Tobacco Withdrawal, Nicotine Addiction, Nicotine Withdrawal, Nicotine Replacement Therapy
- Keywords
- tobacco, bupropion, nicotine replacement therapy, abstinence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- National Institute of Respiratory Diseases, MexicoOther government
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups: 1. Nicotine replacement therapy 2. Nicotine replacement therapy and bupropion
| Arm | Type | Receives |
|---|---|---|
| Nicotine replacement therapy | Active comparator | Drug: Nicotine replacement therapy (Nicotine patches)Nicotine replacement therapy (Nicotine patches) plus counseling and cognitive behavioral therapy |
| Nicotine replacement therapy and Bupropion | Experimental | Drug: Bupropion, Drug: Nicotine replacement therapy (Nicotine patches)Nicotine replacement therapy (Nicotine patches) plus Bupropion and counseling and cognitive behavioral therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- >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
Key exclusion criteria (3 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupropionBupropion will be added at doses of 150 mg to 300 mg per day in addition to nicotine replacement therapy, counseling and cognitive behavioral therapy | Drug | Nicotine replacement therapy and Bupropion |
| Nicotine replacement therapy (Nicotine patches)Nicotine replacement therapy (Nicotine patches) plus counseling and cognitive behavioral therapy | Drug | Nicotine replacement therapy, Nicotine replacement therapy and Bupropion |
Primary outcome
Abstinence at 12 months. Negative cotinine test and negative an exhaled carbon monoxide test
Time frame: 12 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Background: PubMed 31516433Martinez 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.
- Background: PubMed 22592676Rigotti 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.
- Results publication: PubMed 30874290Makate 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.
- Individual participant dataSharing planned: Yes. The data will be collected on the redCap platform, and may be shared in Excel CSV format as well as related dictionaries. SAP, ICF, CSR information will be shared after the results are published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
IRERI THIRION-ROMERO, DR principal investigator
INER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupropion and Nicotine replacement therapy (Nicotine patches) in people with Tobacco Smoking and Tobacco Withdrawal, run by National Institute of Respiratory Diseases, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact IRERI THIRION, DR (55 5487 1700, ireri.thirion@iner.gob.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abstinence at 12 months. Negative cotinine test and negative an exhaled carbon monoxide test (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06254001, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.