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

NCT ID: NCT01850589

Last Updated: 2015-08-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-01-31

Brief Summary

The aim of this study is to prove that the use of Bupropion with counseling works better than counseling alone for patients to quit smoking. The belief is that overall, there is a small percentage of patients who quit smoking all together.

Detailed Description

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.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Conservative Therapy

Conservative therapy:

Subjects counseled by vascular attending/fellow during office appointment to stop smoking.

Counseling consists of:

Self-help materials including "Smart Move: A Stop Smoking Guide" from the American Cancer Society A brief educational discussion on the benefits of smoking cessation.

Patients randomized to Group 1 will be offered adjunctive treatment with nicotine replacement therapy at no cost.

Group Type: OTHER

Aggressive Therapy

Intervention Type: OTHER

Pharmacotherapy adjuncts offered at no cost are as follows:

• Chantix (varenicline) GlaxoSmithKline,
• Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline.

Aggressive Therapy

8 week comprehensive smoking cessation and pharmacotherapy program consisting of:

• One hour group counseling sessions, focusing on patient education and behavior modification.
• Behavior modifications including recognition; coping skills; stress management; and relapse prevention skills.
• Counseling including information on nutrition, exercise, and chemical dependency.

Counseling sessions will be held 256C Mason Avenue. Pharmacotherapy adjuncts offered at no cost are as follows: Chantix (varenicline) GlaxoSmithKline, Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline.

Group Type: OTHER

Aggressive Therapy

Intervention Type: OTHER

Pharmacotherapy adjuncts offered at no cost are as follows:

• Chantix (varenicline) GlaxoSmithKline,
• Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline.

Interventions

Aggressive Therapy

Pharmacotherapy adjuncts offered at no cost are as follows:

• Chantix (varenicline) GlaxoSmithKline,
• Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline.

Intervention Type: OTHER

Other Intervention Names

GlaxoSmithKline, Zyban,Nicoderm/Nicroette GlaxoSmithKline.

Eligibility Criteria

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 angiography

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 years.

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

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 medications.

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 =[(140-age(yr)]*weight(kg)]/[72*serumCr(mg/dL)].

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Deitch

Program Director, Vascular Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan Deitch, MD

Role: PRINCIPAL_INVESTIGATOR

North Shore- LIJ Health System (SIUH)

Locations

Staten Island University Hospital

Staten Island, New York, United States

Countries

United States

Other Identifiers

11-001

Identifier Type: -

Identifier Source: org_study_id