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Bupropion for Hospitalized Smokers With Acute Cardiovascular Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00181818
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : September 16, 2005
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Massachusetts General Hospital

Brief Summary:
The purpose of the study is to test the efficacy and safety of bupropion SR for smokers hospitalized with acute cardiovascular disease.

Condition or disease Intervention/treatment Phase
Smoking Myocardial Infarction Unstable Angina Cardiovascular Disease Drug: bupropion SR (sustained-release) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Sustained-Release (SR) Bupropion for Smokers Hospitalized Smokers With Acute Coronary Heart Disease
Study Start Date : October 1999
Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up
  2. Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)

Secondary Outcome Measures :
  1. Combined fatal and nonfatal cardiovascular events at 3 month follow-up (end of treatment)
  2. Combined fatal and nonfatal cardiovascular events at 1 year follow-up
  3. Cardiovascular mortality at 1 year follow-up
  4. Blood pressure elevation (SBP>160 or DBP>100) during treatment with study drug

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00181818

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Nancy A Rigotti, MD Massachusetts General Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00181818    
Other Study ID Numbers: 1999-P-002639
NIH: R01 HL61779
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 16, 2005
Last Verified: September 2005
Keywords provided by Massachusetts General Hospital:
Smoking cessation
Bupropion SR
Hospital intervention
Myocardial infarction
Unstable angina
Additional relevant MeSH terms:
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Cardiovascular Diseases
Myocardial Infarction
Angina, Unstable
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Neurologic Manifestations
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors