Back to resultsComparison of Conservative and Aggressive Smoking Cessation Treatment Strategies in a Vascular Surgery Office Practice
Primary Purpose
Smoking Cessation
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aggressive Therapy
Sponsored by
About this trial
This is an interventional prevention trial for Smoking Cessation
Eligibility Criteria
Inclusion Criteria:
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:
- Ankle-brachial index of <.90 in at least 1 lower extremity.
- Toe-brachial index of <.60
- Objective evidence of arterial occlusive disease in 1 lower extremity by duplex ultrasonography, magnetic resonance angiography or computed tomographic angiography
- prior leg arterial revascularization or amputation due to PAD
- Patients have to smoke with a minimum of 10 cigarettes per day for a minimum of 5 years.
- Patients must be able to give informed written consent and be at least 18 years of age.
Exclusion Criteria:
- 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.
- 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.
- Patients with a history of a seizure disorder. Zyban (bupropion) is contraindicated in patients with preexisting seizure disorder.
- 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.
- 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.
- 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)].
- 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.
- Patients with vascular pathology other than PAD (Carotid atherosclerosis, abdominal aortic aneurysms, venous insufficiency).
- 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.
Sites / Locations
- Staten Island University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Conservative Therapy
Aggressive Therapy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of Participants With Smoking Cessation at 12 Months
Conservative vs. aggressive smoking strategies in treating smoking cessation.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01850589
Brief Title
Comparison of Conservative and Aggressive Smoking Cessation Treatment Strategies in a Vascular Surgery Office Practice
Official Title
Comparison of Conservative and Aggressive Smoking Cessation Treatment Strategies in a Vascular Surgery Office Practice
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
Use of bupropion with counseling works better to help patients quit smoking.
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conservative Therapy
Arm Type
Other
Arm Description
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.
Arm Title
Aggressive Therapy
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Aggressive Therapy
Other Intervention Name(s)
GlaxoSmithKline, Zyban,Nicoderm/Nicroette GlaxoSmithKline.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Smoking Cessation at 12 Months
Description
Conservative vs. aggressive smoking strategies in treating smoking cessation.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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:
Ankle-brachial index of <.90 in at least 1 lower extremity.
Toe-brachial index of <.60
Objective evidence of arterial occlusive disease in 1 lower extremity by duplex ultrasonography, magnetic resonance angiography or computed tomographic angiography
prior leg arterial revascularization or amputation due to PAD
Patients have to smoke with a minimum of 10 cigarettes per day for a minimum of 5 years.
Patients must be able to give informed written consent and be at least 18 years of age.
Exclusion Criteria:
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.
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.
Patients with a history of a seizure disorder. Zyban (bupropion) is contraindicated in patients with preexisting seizure disorder.
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.
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.
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)].
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.
Patients with vascular pathology other than PAD (Carotid atherosclerosis, abdominal aortic aneurysms, venous insufficiency).
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Deitch, MD
Organizational Affiliation
North Shore- LIJ Health System (SIUH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Staten Island University Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Conservative and Aggressive Smoking Cessation Treatment Strategies in a Vascular Surgery Office Practice
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