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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01850589
• Other study ID #: 11-001
• Status: Terminated
• Phase: N/A
• First received: April 8, 2013
• Last updated: July 28, 2015
• Start date: March 2011
• Est. completion date: January 2013

Study information

• Verified date: July 2015
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Staten Island University Hospital	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Smoking Cessation at 12 Months	Conservative vs. aggressive smoking strategies in treating smoking cessation.	12 months	No