Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00181818
Status:
COMPLETED
Last Update Posted:
2005-09-16
First Post:
2005-09-13
Brief Title:
Bupropion for Hospitalized Smokers With Acute Cardiovascular Disease
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Safety and Efficacy of Sustained-Release SR Bupropion for Smokers Hospitalized Smokers With Acute Coronary Heart Disease
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIH R01 HL61779 | None | None | None |