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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
  Purpose

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. .


Condition Intervention
Nicotine Dependence
Tobacco Dependence
Cardiac Disease
 Behavioral: smoking reduction intervention (including NRT)

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Smoking reduction

Secondary Outcome Measures:
  • Smoking cessation, biomarker measures

Estimated Enrollment: 180
Study Start Date: October 2000
Estimated Study Completion Date: January 2005
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00301626

Locations
United States, Minnesota
Minneapolis VAMC (111-0)
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
National Institutes of Health (NIH)
Investigators
Principal Investigator: Anne Joseph, MD, MPH Minneapolis VAMC & University of Minnesota
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00301626     History of Changes
Other Study ID Numbers: DA13333-02
Study First Received: March 10, 2006
Last Updated: October 23, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Minneapolis Veterans Affairs Medical Center:
tobacco
nicotine
smoking reduction

Additional relevant MeSH terms:
Heart Diseases
Tobacco Use Disorder
Cardiovascular Diseases
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013