Bupropion for Hospitalized Smokers With Acute Cardiovascular Disease

Last updated: September 13, 2005
Sponsor: Massachusetts General Hospital
Overall Status: Completed

Phase

4

Condition

Heart Defect

Vascular Diseases

Myocardial Ischemia

Treatment

N/A

Clinical Study ID

NCT00181818
1999-P-002639
NIH: R01 HL61779
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 (seebelow)

  • had an expected hospital stay of >24 hours. Eligible admission diagnoses included (1) acute ischemic coronary heart disease (MI orunstable angina), (2) coronary artery bypass graft surgery, or (3) other cardiovascularconditions (congestive heart failure, cardiac arrhythmia, valvular heart disease, oratherosclerotic disease of the aorta, carotid, renal or peripheral arteries) in subjectswith documented coronary artery disease.

Exclusion

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 ofconsciousness

  • uncontrolled hypertension (BP >160/100) in hospital

  • heavy alcohol use (>3 drinks/day) or binge drinking (>6 drinks for males or >5 drinksfor 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

Total Participants: 248
Study Start date:
October 01, 1999
Estimated Completion Date:
December 31, 2003

Study 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.

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

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