Cardiovascular Disease, Tobacco Use Disorder
Conditions
Keywords
Smoking cessation, cardiovascular disease, smoking reduction, nicotine replacement
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.
Interventions
For reduction
No drugs
Sponsors
Study design
Eligibility
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).
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Withdrawal symptoms | ongoing through 6 months |
Countries
United States