Reduction of Smoking in Cardiac Disease Patients

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

Detailed Description
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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.

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

Conditions
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Cardiovascular Disease, Tobacco Use Disorder

Intervention / Treatment
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* Drug: Nicotine replacement
* Behavioral: Motivational counseling


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Usual care | Behavioral: Motivational counseling<br>* No drugs<br>* Other names: Behavioral counseling;|
| Other: 2<br>Reduction | Drug: Nicotine replacement<br>* For reduction<br>* Other names: Nicoderm, Nicorrette;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cigarettes per day |  | 6 months | 
| ASCVD health changes |  | 6 months | 
| Days of abstinence from cigarettes |  | 6 months | 
| Number of quit attempts |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Withdrawal symptoms |  | ongoing through 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking reduction, Smoking cessation, cardiovascular disease, nicotine replacement