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

NCT01850589 | Terminated Results DMC

• 1 other identifier: 11-001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Smoking Cessation at 12 Months

  Conservative vs. aggressive smoking strategies in treating smoking cessation.

  12 months

Study Arms (2)

Conservative Therapy

OTHER

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.

Other: Aggressive Therapy

Aggressive Therapy

OTHER

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.

Other: Aggressive Therapy

Interventions

Aggressive Therapy 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.

Also known as: GlaxoSmithKline, Zyban,Nicoderm/Nicroette GlaxoSmithKline.

Aggressive Therapy; Conservative Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

halofantrine; Bupropion

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Results Point of Contact

• Title: Dr. Jonathan Deitch, PI, Director of Vascular Surgery
• Organization: Staten Island University Hospital

jonathan_deitch@siuh.edu

718-226-9000

Study Officials

• Jonathan Deitch, MD

  North Shore- LIJ Health System (SIUH)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director, Vascular Surgery

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: May 9, 2013
• Study Start: March 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: August 3, 2015
• Results First Posted: August 3, 2015

Record last verified: 2015-07

Locations

US (1)