Reduction of Smoking in Cardiac Disease Patients

Cardiovascular Disease Clinical Trial

Official title: Harm Reduction Treatment for Smokers With Cardiovascular Disease {Reduction of Smoking in Cardiovascular Disease Patients (ROSCAP)}

Status Completed

Clinical Trial Summary

This study evaluates the effect of smoking reduction vs usual care (quitting advice only) for individuals with peripheral arterial disease who smoke.

Clinical Trial Description

This study randomly assigns smokers who do not have a quit date set to either a smoking reduction grop or usual care group. The smoking reduction group receives behavioral counseling on smoking reduction and nicotine patch and/or gum to reduce the number of cigarettes smoked per day by at least 50%. The usual care group is given brief advice to quit smoking and referral to local cessation services. To be included in the study, participants must have peripheral arterial disease (defined as ankle Brachial Index equal to or less than 0.85 or history of prior revascularization) and they must be daily smokers (defined as at least 1 cigarette, cigar, or tobacco pipe daily). Participants complete questionnaires that measure mood, functional ability, smoking history, and motivation to quit smoking. Participants will be followed in this study for up to 24 months. ;

Study Design

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Tobacco Use Disorder

• NCT number: NCT00469885
• Study type: Interventional
• Source: National Institute on Drug Abuse (NIDA)
• Status: Completed
• Phase: Phase 2
• Start date: January 2001
• Completion date: December 2005