Smoking CessationNCT01850589
Comparison of Conservative and Aggressive Smoking Cessation Treatment Strategies in a Vascular Surgery Office Practice
A study testing Aggressive Therapy in people with Smoking Cessation, run by Northwell Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Aggressive Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jan 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)].
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Staten Island University Hospital
Staten Island, New York, 10305
About this study
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.
Read the 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
- Being tested
- Aggressive Therapy
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aggressive TherapyOther
Also called GlaxoSmithKline, Zyban,Nicoderm/Nicroette GlaxoSmithKline.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Aggressive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Smoking Cessation at 12 Months
Conservative vs. aggressive smoking strategies in treating smoking cessation.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startMar 2011
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: Use of bupropion with counseling works better to help patients quit smoking.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Deitch, Northwell Health
- Investigators
- Jonathan Deitch, MD, Principal investigator, North Shore- LIJ Health System (SIUH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850589
- Sponsor's protocol ID
- 11-001
- Status last verified
- Jul 2015
- First submitted
- 8 Apr 2013
- Last updated
- 3 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conservative and Aggressive Smoking Cessation Treatment Strategies in a Vascular Surgery Office Practice
- ClinicalTrials.gov ID
- NCT01850589
- Acronym / sponsor ID
- 11-001
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Use of bupropion with counseling works better to help patients quit smoking.
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 9 May 2013 (estimated)
- Results
- Posted 3 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative Therapy | Other | Other: Aggressive TherapyConservative 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. |
| Aggressive Therapy | Other | Other: Aggressive Therapy8 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aggressive TherapyAlso: GlaxoSmithKline, Zyban,Nicoderm/Nicroette GlaxoSmithKline.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, Conservative Therapy |
Primary outcome
Number of Participants With Smoking Cessation at 12 Months
Time frame: 12 months
Conservative vs. aggressive smoking strategies in treating smoking cessation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Deitch, MD principal investigator
North Shore- LIJ Health System (SIUH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aggressive Therapy in people with Smoking Cessation, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Smoking Cessation at 12 Months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2015.