Completed

Bupropion SR for Smoking Cessation in Hospitalized Acute Coronary Heart Disease Patients

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What is being tested

Data Collection

Who is being recruted

Angina Pectoris+17

+ Angina, Unstable

+ Behavior

Over 18 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: October 1999
See protocol details

Summary

Principal SponsorMassachusetts General Hospital
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 1999

Actual date on which the first participant was enrolled.

Every year, around 2 million people in the U.S. are hospitalized due to heart disease, specifically conditions like heart attack or unstable angina. For the 20% of these patients who smoke, quitting smoking is highly recommended and cost-effective. Hospitalization is a great opportunity to start smoking cessation, as it enforces temporary smoking abstinence and increases smokers' motivation to quit. However, even with the best counseling, at least 40% of smokers fail to quit. This study aims to test if adding a medication called Sustained-Release (SR) Bupropion (Zyban, Wellbutrin SR) to behavioral counseling can help. This drug is a non-nicotine antidepressant that has shown to be effective for smoking cessation and safe for heart patients. It may also prevent depression after a heart attack, which is a separate risk factor for death. In this study, adult smokers hospitalized with heart attack or unstable angina are given SR Bupropion or a placebo, starting in the hospital and continuing for 12 weeks. This is done along with comprehensive smoking counseling. The main goal is to see if the drug helps patients stay away from tobacco for a week at the one-year follow-up. Secondary goals include checking if the drug helps patients stay away from tobacco for a week at the end of treatment (12 weeks), delays the time to smoking relapse, reduces heart disease complications and depressive symptoms, and improves quality of life over one year.

Official TitleSafety and Efficacy of Sustained-Release (SR) Bupropion for Smokers Hospitalized Smokers With Acute Coronary Heart Disease
NCT00181818
Principal SponsorMassachusetts General Hospital
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

248 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Angina PectorisAngina, UnstableBehaviorCardiovascular DiseasesChest PainHeart DiseasesInfarctionIschemiaMyocardial InfarctionNecrosisNeurologic ManifestationsPainPathologic ProcessesSigns and SymptomsSmokingPathological Conditions, Signs and SymptomsVascular DiseasesHealth BehaviorSmoking CessationMyocardial Ischemia

Criteria

7 inclusion criteria required to participate
acute ischemic coronary heart disease (MI or unstable angina)

coronary artery bypass graft surgery

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

>18 years old

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14 exclusion criteria prevent from participating
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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Massachusetts General Hospital

Boston, United StatesOpen Massachusetts General Hospital in Google Maps
CompletedOne Study Center