SmokingPhase 4NCT00181818
Bupropion for Hospitalized Smokers With Acute Cardiovascular Disease
A Phase 4 study testing bupropion SR (sustained-release) in people with Smoking and Myocardial Infarction, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of the study is to test the efficacy and safety of bupropion SR for smokers hospitalized with acute cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Myocardial Infarction, Unstable Angina
- What is being tested?
- bupropion SR (sustained-release)
- How many people
- 248 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1999to Dec 2003
- 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 old,
- had smoked >1 cigarette in the past month,
- were admitted to the hospital with a diagnosis of acute cardiovascular disease (see below)
- had an expected hospital stay of >24 hours.
- Eligible admission diagnoses included (1) acute ischemic coronary heart disease (MI or unstable angina), (2) coronary artery bypass graft surgery, or (3) other cardiovascular conditions (congestive heart failure, cardiac arrhythmia, valvular heart disease, or atherosclerotic disease of the aorta, carotid, renal or peripheral arteries) in subjects with documented coronary artery disease.
Who cannot join
- not willing to consider smoking cessation after discharge,
- a contraindication to bupropion (seizure disorder, monoamine oxidase inhibitor use, history of anorexia nervosa or bulimia, bupropion allergy)
- a condition that increased the risk of seizure (e.g., serious head trauma with loss of consciousness
- uncontrolled hypertension (BP >160/100) in hospital
- heavy alcohol use (>3 drinks/day) or binge drinking (>6 drinks for males or >5 drinks for females) at least monthly
- renal insufficiency (serum creatinine >2.0 mg/dl),
Show all 14Show fewer
- severe hepatic disease
- severe depression or severe cognitive impairment or psychosis
- life expectancy of <12 months,
- illegal drug use in the past 6 months
- bupropion use in the past month
- non-English speaking
- no telephone
- residence outside a defined geographic area.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Safety and Efficacy of Sustained-Release (SR) Bupropion for Smokers Hospitalized Smokers With Acute Coronary Heart Disease
The purpose of the study is to test the efficacy and safety of bupropion SR for smokers hospitalized with acute cardiovascular disease.
Read the detailed description
Each year, over 2 million Americans are hospitalized with a myocardial infarction (MI) or unstable angina pectoris, two acute and potentially fatal manifestations of coronary heart disease (CHD). Smoking cessation is highly cost-effective and universally recommended for the approximately 20% of these patients who smoke. Hospitalization for acute CHD is an excellent time to initiate smoking cessation because hospitalization requires temporary tobacco abstinence at the same time that illness increases smokers' motivation to quit. Unfortunately, at least 40% of smokers fail to quit even with optimal cognitive-behavioral counseling interventions that begin in the hospital and continue after discharge. More powerful intervention strategies are needed. Adding pharmacotherapy to behavioral counseling, which is standard practice in outpatients, has not been tested in this setting because of concern about the safety of nicotine replacement after MI. Sustained release (SR) bupropion (Zyban, Wellbutrin SR) is a non-nicotine antidepressant drug that has recently proved to be effective for smoking cessation. It appears to be safe in cardiac patients and may have the additional benefit of preventing post-MI depression, an independent predictor of mortality.
This study tested the efficacy and safety of bupropion SR for smoking cessation in adult smokers hospitalized with MI or unstable angina. To do so, we conducted a five-site randomized double-blind placebo-controlled trial to determine whether bupropion SR, initiated in the hospital and continued for 12 weeks, was effective and safe when added to comprehensive cognitive-behavioral smoking counseling. The primary outcome measure was biochemically-confirmed 7-day point prevalence tobacco abstinence at 1 year follow-up. Principal secondary outcome measure was biochemically-confirmed 7-day point-prevalence at end-of-treatment (12 weeks). Secondary aims were to test whether bupropion SR delays the time to smoking relapse, reduces CHD morbidity and depressive symptoms, and improves health-related quality of life over 1 year of follow-up.
- Being tested
- bupropion SR (sustained-release)
- Keywords
- Smoking cessation, Bupropion SR, Hospital intervention, Myocardial infarction, Unstable angina
- Medical subject headings
- Smoking, Myocardial Infarction, Angina, Unstable, Cardiovascular Diseases, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupropion SR (sustained-release)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up
Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)
Secondary outcomes (4)
Combined fatal and nonfatal cardiovascular events at 3 month follow-up (end of treatment)
Combined fatal and nonfatal cardiovascular events at 1 year follow-up
Cardiovascular mortality at 1 year follow-up
Blood pressure elevation (SBP>160 or DBP>100) during treatment with study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startOct 1999
- Study completionDec 2003
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 SmokingStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Enrolment
- 248 participants
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Nancy A Rigotti, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181818
- Sponsor's protocol ID
- 1999-P-002639
- Other IDs
- NIH: R01 HL61779
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 16 Sep 2005
- Results posted
- No
Publications
Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
PubMed 37230961Thorndike AN, Regan S, McKool K, Pasternak RC, Swartz S, Torres-Finnerty N, Rigotti NA. Depressive symptoms and smoking cessation after hospitalization for cardiovascular disease. Arch Intern Med. 2008 Jan 28;168(2):186-91. doi: 10.1001/archinternmed.2007.60.
PubMed 18227366Rigotti NA, Thorndike AN, Regan S, McKool K, Pasternak RC, Chang Y, Swartz S, Torres-Finnerty N, Emmons KM, Singer DE. Bupropion for smokers hospitalized with acute cardiovascular disease. Am J Med. 2006 Dec;119(12):1080-7. doi: 10.1016/j.amjmed.2006.04.024.
PubMed 17145253
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Sustained-Release (SR) Bupropion for Smokers Hospitalized Smokers With Acute Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT00181818
- Acronym / sponsor ID
- 1999-P-002639
- Keywords
- Smoking cessation, Bupropion SR, Hospital intervention, Myocardial infarction, Unstable angina
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), GlaxoSmithKline
- Study start
- Oct 1999
- Study completion
- Dec 2003
- First posted
- 16 Sep 2005 (estimated)
- 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.
The purpose of the study is to test the efficacy and safety of bupropion SR for smokers hospitalized with acute cardiovascular disease.
Detailed description
Each year, over 2 million Americans are hospitalized with a myocardial infarction (MI) or unstable angina pectoris, two acute and potentially fatal manifestations of coronary heart disease (CHD). Smoking cessation is highly cost-effective and universally recommended for the approximately 20% of these patients who smoke. Hospitalization for acute CHD is an excellent time to initiate smoking cessation because hospitalization requires temporary tobacco abstinence at the same time that illness increases smokers' motivation to quit. Unfortunately, at least 40% of smokers fail to quit even with optimal cognitive-behavioral counseling interventions that begin in the hospital and continue after discharge. More powerful intervention strategies are needed. Adding pharmacotherapy to behavioral counseling, which is standard practice in outpatients, has not been tested in this setting because of concern about the safety of nicotine replacement after MI. Sustained release (SR) bupropion (Zyban, Wellbutrin SR) is a non-nicotine antidepressant drug that has recently proved to be effective for smoking cessation. It appears to be safe in cardiac patients and may have the additional benefit of preventing post-MI depression, an independent predictor of mortality.
This study tested the efficacy and safety of bupropion SR for smoking cessation in adult smokers hospitalized with MI or unstable angina. To do so, we conducted a five-site randomized double-blind placebo-controlled trial to determine whether bupropion SR, initiated in the hospital and continued for 12 weeks, was effective and safe when added to comprehensive cognitive-behavioral smoking counseling. The primary outcome measure was biochemically-confirmed 7-day point prevalence tobacco abstinence at 1 year follow-up. Principal secondary outcome measure was biochemically-confirmed 7-day point-prevalence at end-of-treatment (12 weeks). Secondary aims were to test whether bupropion SR delays the time to smoking relapse, reduces CHD morbidity and depressive symptoms, and improves health-related quality of life over 1 year of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >18 years old,
- had smoked >1 cigarette in the past month,
- were admitted to the hospital with a diagnosis of acute cardiovascular disease (see below)
- had an expected hospital stay of >24 hours.
- Eligible admission diagnoses included (1) acute ischemic coronary heart disease (MI or unstable angina), (2) coronary artery bypass graft surgery, or (3) other cardiovascular conditions (congestive heart failure, cardiac arrhythmia, valvular heart disease, or atherosclerotic disease of the aorta, carotid, renal or peripheral arteries) in subjects with documented coronary artery disease.
Key exclusion criteria (14 listed)
- not willing to consider smoking cessation after discharge,
- a contraindication to bupropion (seizure disorder, monoamine oxidase inhibitor use, history of anorexia nervosa or bulimia, bupropion allergy)
- a condition that increased the risk of seizure (e.g., serious head trauma with loss of consciousness
- uncontrolled hypertension (BP >160/100) in hospital
- heavy alcohol use (>3 drinks/day) or binge drinking (>6 drinks for males or >5 drinks for females) at least monthly
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 |
|---|---|---|
| bupropion SR (sustained-release) | Drug | – |
Primary outcome
Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up
Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)
4 secondary outcomes
Combined fatal and nonfatal cardiovascular events at 3 month follow-up (end of treatment)
Combined fatal and nonfatal cardiovascular events at 1 year follow-up
Cardiovascular mortality at 1 year follow-up
Blood pressure elevation (SBP>160 or DBP>100) during treatment with study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2005.
- Derived from this study: PubMed 37230961Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
- Derived from this study: PubMed 18227366Thorndike AN, Regan S, McKool K, Pasternak RC, Swartz S, Torres-Finnerty N, Rigotti NA. Depressive symptoms and smoking cessation after hospitalization for cardiovascular disease. Arch Intern Med. 2008 Jan 28;168(2):186-91. doi: 10.1001/archinternmed.2007.60.
- Derived from this study: PubMed 17145253Rigotti NA, Thorndike AN, Regan S, McKool K, Pasternak RC, Chang Y, Swartz S, Torres-Finnerty N, Emmons KM, Singer DE. Bupropion for smokers hospitalized with acute cardiovascular disease. Am J Med. 2006 Dec;119(12):1080-7. doi: 10.1016/j.amjmed.2006.04.024.
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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.
Nancy A Rigotti, MD principal investigator
Massachusetts General Hospital
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 SR (sustained-release) in people with Smoking and Myocardial Infarction, run by Massachusetts General Hospital at 1 site in United States.
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 5 inclusion and 14 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: finished, as of the sponsor's last update on 16 Sep 2005. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up. The study lists 2 primary outcomes in all. 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 NCT00181818, 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 16 Sep 2005.