Smoking Cessation
Conditions
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.
Interventions
OTHERAggressive 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.
Sponsors
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Smoking Cessation at 12 Months | 12 months | Conservative vs. aggressive smoking strategies in treating smoking cessation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conserative Therapy Patients counseled by the 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 and 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. | 14 |
| 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.
Varenicline, Bupropion,and nicotine nasal spray, inhaler, transdermal patches and gum: 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. | 22 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 8 | 0 |
Baseline characteristics
| Characteristic | Conserative Therapy | Aggressive Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 22 Participants | 36 Participants |
| Sex/Gender, Customized Unspecified Gender | 14 Participants | 22 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
Number of Participants With Smoking Cessation at 12 Months
Conservative vs. aggressive smoking strategies in treating smoking cessation.
Time frame: 12 months
Population: Mean follow up was 7.3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Conserative Therapy | Number of Participants With Smoking Cessation at 12 Months | 4 Participants |
| Aggressive Therapy | Number of Participants With Smoking Cessation at 12 Months | 10 Participants |