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Comparison of Conservative and Aggressive Smoking Cessation Treatment Strategies in a Vascular Surgery Office Practice

18 Years
Not Enrolling
Smoking Cessation

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Trial Information

Comparison of Conservative and Aggressive Smoking Cessation Treatment Strategies in a Vascular Surgery Office Practice

The objective of the current investigation is to evaluate the effectiveness of an intensive
verses conservative smoking cessation program in patients with peripheral arterial disease
in an outpatient setting.

Inclusion Criteria:

1. All patients with confirmed peripheral arterial disease (PAD), defined as at least
one of the following criteria, during the initial Vascular Surgery Office exam and
review of the patient's medical record:

1. Ankle-brachial index of <.90 in at least 1 lower extremity.

2. Toe-brachial index of <.60

3. Objective evidence of arterial occlusive disease in 1 lower extremity by duplex
ultrasonography, magnetic resonance angiography or computed tomographic

4. prior leg arterial revascularization or amputation due to PAD

2. Patients have to smoke with a minimum of 10 cigarettes per day for a minimum of 5

3. Patients must be able to give informed written consent and be at least 18 years of

Exclusion Criteria:

1. Pregnant women: Smoking Cessation Program medication Chantix (varenicline), Zyban
(bupropion) has been shown to cause decreased fertility and decrease fetal weight in
animal study offspring.

2. Patients less than 18 years of age: Safe and effective use in children has not been
established with Chantix (varenicline) and Zyban (bupropion). These medications are
not approved for use in individuals less than 18 years of old.

3. Patients with a history of a seizure disorder. Zyban (bupropion) is contraindicated
in patients with preexisting seizure disorder.

4. Patients with a history of anorexia nervosa or bulimia nervosa. Patients with these
eating disorders have been shown to have an increased incidence of seizures and Zyban
(bupropion) is contraindicated in patients with a history or anorexia nervosa and
bulimia nervosa.

5. The use bupropion concomitantly with monoamine oxidase inhibitors (MAOIs), including
drugs with MAOI-like activity is contraindicated. Studies with animals indicate that
bupropion-induced adverse reaction and toxicity appear to be enhanced by these

6. Patients with renal insufficiency;defined as having a Creatinine Clearance (CrCl)
<=50mL/min. Chantix is substantially excreted by the kidneys and the risk of toxic
reactions are greater in patients with impaired renal function. Creatinine Clearance

7. Patients with hepatic insufficiency; defined as having elevated liver function tests
(serum aminotransferases) greater than 1.5 baseline. Zyban is metabolized in the
liver. Half-lives of bupropion and/or its major metabolites are prolonged in patients
with liver disease.

8. Patients with vascular pathology other than PAD (Carotid atherosclerosis, abdominal
aortic aneurysms, venous insufficiency).

9. Subjects with a history of psychiatric illness requiring current treatment with
psychoactive medications, a history of dependence on alcohol or non nicotine
substance in the past year or current use of tobacco products other than cigarettes.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Outcome Measure:

A Change in Smoking Cessation Survey Results

Outcome Description:

Patients will complete the questionnaire provided to them by the Vascular Surgery attending/fellow during voluntary, free outpatient visits at the Vascular Surgery Office at Staten Island University Hospital.

Outcome Time Frame:

3 months, 6 months and 12 months

Safety Issue:


Principal Investigator

Jonathan Deitch, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Shore- LIJ (SIUH)


United States: Institutional Review Board

Study ID:




Start Date:

March 2011

Completion Date:

January 2013

Related Keywords:

  • Smoking Cessation
  • Smoking