Bupropion for Hospitalized Smokers With Acute Cardiovascular Disease

Myocardial Infarction Clinical Trial

Official title:

Safety and Efficacy of Sustained-Release (SR) Bupropion for Smokers Hospitalized Smokers With Acute Coronary Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00181818
• Other study ID #: 1999-P-002639
• Secondary ID: NIH: R01 HL61779
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: September 13, 2005
• Start date: October 1999
• Est. completion date: December 2003

Study information

• Verified date: September 2005
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina, Unstable
• Cardiovascular Disease
• Cardiovascular Diseases
• Infarction
• Myocardial Infarction
• Smoking
• Unstable Angina

Intervention

Drug:
• bupropion SR (sustained-release)

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	GlaxoSmithKline, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up
Primary	Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)
Secondary	Combined fatal and nonfatal cardiovascular events at 3 month follow-up (end of treatment)
Secondary	Combined fatal and nonfatal cardiovascular events at 1 year follow-up
Secondary	Cardiovascular mortality at 1 year follow-up
Secondary	Blood pressure elevation (SBP>160 or DBP>100) during treatment with study drug