ROSCAP: Reduction of Smoking in Cardiac Patients Study

Nicotine Dependence Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00301626
• Other study ID #: DA13333-02
• Status: Completed
• Phase: N/A
• First received: March 10, 2006
• Last updated: October 23, 2008
• Start date: October 2000
• Est. completion date: January 2005

Study information

• Verified date: April 2005
• Source: Minneapolis Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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. .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases
• Nicotine Dependence
• Tobacco Dependence

Intervention

Behavioral:
• smoking reduction intervention (including NRT)

Locations

Country	Name	City	State
United States	Minneapolis VAMC (111-0)	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking reduction
Secondary	Smoking cessation, biomarker measures