Reduction of Smoking in Cardiac Disease Patients

Phase 2

Completed

• Conditions: Cardiovascular Disease; Tobacco Use Disorder
• Interventions: Drug: Nicotine replacement; Behavioral: Motivational counseling

• Registration Number: NCT00469885
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

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

Detailed 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 Timeline

• Study Start: 2001-01
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Study First Submitted: 2007-05-03
• Study First Submitted QC: 2007-05-04
• Study First Posted: 2007-05-07
• Status Verified: 2008-06
• Last Update Submitted: 2017-01-09
• Last Update Posted: 2017-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

• 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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Nicotine replacement	Reduction
1	Motivational counseling	Usual care

Primary Outcome Measures

Name	Time	Method
ASCVD health changes	6 months
Number of cigarettes per day	6 months
Number of quit attempts	6 months
Days of abstinence from cigarettes	6 months

Secondary Outcome Measures

Name	Time	Method
Withdrawal symptoms	ongoing through 6 months

Trial Locations

Locations (2)

Univeristy of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Univerisity of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States