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Reduction of Smoking in Cardiac Disease Patients

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status and phase

Completed
Phase 2

Conditions

Tobacco Use Disorder
Cardiovascular Disease

Treatments

Drug: Nicotine replacement
Behavioral: Motivational counseling

Study type

Interventional

Funder types

NIH

Identifiers

NCT00469885
NIDA P50 DA13333
P50DA13333-8

Details and patient eligibility

About

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

Full 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.

Enrollment

152 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

152 participants in 2 patient groups

1
Other group
Description:
Usual care
Treatment:
Behavioral: Motivational counseling
2
Other group
Description:
Reduction
Treatment:
Drug: Nicotine replacement

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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