Status:
COMPLETED
Bupropion for Hospitalized Smokers With Acute Cardiovascular Disease
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
GlaxoSmithKline
Conditions:
Smoking
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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). Smok...
Eligibility Criteria
Inclusion
- \>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
- 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.
Key Trial Info
Start Date :
October 1 1999
Trial Type :
INTERVENTIONAL
End Date :
December 1 2003
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT00181818
Start Date
October 1 1999
End Date
December 1 2003
Last Update
September 16 2005
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114