ROSCAP: Reduction of Smoking in Cardiac Patients Study

This study has been completed.

Sponsor:

Information provided by:

Minneapolis Veterans Affairs Medical Center

ClinicalTrials.gov Identifier:

NCT00301626

First received: March 10, 2006

Last updated: October 23, 2008

Last verified: April 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

March 10, 2006

Last Updated Date

October 23, 2008

Start Date ^ICMJE

October 2000

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Smoking reduction

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00301626 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Smoking cessation, biomarker measures

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

ROSCAP: Reduction of Smoking in Cardiac Patients Study

Official Title ^ICMJE

Not Provided

Brief Summary

Background. The ROSCAP Study was a randomized controlled trial in heart disease patients to test the effect of a smoking reduction intervention on cigarettes per day (cpd) and biochemical and clinical indicators of tobacco exposure. .

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label

Condition ^ICMJE

Nicotine Dependence
Tobacco Dependence
Cardiac Disease

Intervention ^ICMJE

Behavioral: smoking reduction intervention (including NRT)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

180

Completion Date

January 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

smoked at least 15 cigarettes per day and had one of 11 cardiovascular disorders: history of myocardial infarction, coronary artery bypass surgery, angioplasty, stent placement, thrombolytic therapy, angina, arrhythmia, a history of cardiac arrest, greater than 50% coronary artery stenosis by angiography, ischemia on exercise tolerance testing or congestive heart failure, required to confirm that they were unwilling or uninterested in setting a stop smoking date in the next 30 days.

Exclusion Criteria:

1) unstable angina within the past 2 weeks, 2) unstable psychiatric or substance use disorders or 3) contraindications to nicotine replacement therapy (including pregnancy or intention to become pregnant)

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00301626

Other Study ID Numbers ^ICMJE

DA13333-02

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

National Institutes of Health (NIH)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Anne Joseph, MD, MPH

Minneapolis VAMC & University of Minnesota

Information Provided By

Minneapolis Veterans Affairs Medical Center

Verification Date

April 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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