Bupropion for Hospitalized Smokers With Acute Cardiovascular Disease

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: GlaxoSmithKline; National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Bupropion

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.