Bupropion for Hospitalized Smokers With Acute Cardiovascular Disease

NCT ID: NCT00181818

Last Updated: 2005-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-10-31
• Study Completion Date: 2003-12-31

Brief Summary

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.

Conditions

Smoking; Myocardial Infarction; Unstable Angina; Cardiovascular Disease

Keywords

Smoking cessation; Bupropion SR; Hospital intervention; Myocardial infarction; Unstable angina

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

bupropion SR (sustained-release)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• >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.

Exclusion Criteria

• 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),
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Nancy A Rigotti, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37230961 (View on PubMed)

Thorndike 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.

Reference Type: DERIVED

PMID: 18227366 (View on PubMed)

Rigotti 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.

Reference Type: DERIVED

PMID: 17145253 (View on PubMed)

Other Identifiers

NIH: R01 HL61779

Identifier Type: -

Identifier Source: secondary_id

1999-P-002639

Identifier Type: -

Identifier Source: org_study_id