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Combination Medications vs. Patch Alone for Medically-Ill Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00770666
Recruitment Status : Completed
First Posted : October 10, 2008
Last Update Posted : October 10, 2008
Rutgers Cancer Institute of New Jersey
Robert Wood Johnson Foundation
Information provided by:
Rutgers, The State University of New Jersey

Brief Summary:
Randomized clinical trial to evaluate a flexibly-dosed-3-medication combination for up to 6 months in smokers with medical illness

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Nicotine patch, nicotine inhaler, bupropion Drug: Nicotine patch Phase 4

Detailed Description:
Subjects randomly received either nicotine patch alone for a 10-week, tapering course (n=64) or the combination of nicotine patch, nicotine oral inhaler, and bupropion for an ad-lib duration (n=63).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Flexibly-Dosed Combination Pharmacotherapy Versus Standard-Dosed Nicotine Patch Alone for Smokers With Medical Illness
Study Start Date : September 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Nicotine patch, nicotine inhaler, bupropion
Drug: Nicotine patch, nicotine inhaler, bupropion
Patch - 21 mg - taper as able Inhaler - as needed Bupropion SR 150 mg daily

Active Comparator: 2
Nicotine patch
Drug: Nicotine patch
21 mg daily for 6 weeks followed by 14 mg for 2 weeks and then 7 mg for 2 weeks

Primary Outcome Measures :
  1. Tobacco use abstinence [ Time Frame: 26 week ]

Secondary Outcome Measures :
  1. Time to first relapse [ Time Frame: varies ]
  2. Duration of medication use [ Time Frame: 26 weeks ]
  3. Adverse clinical events [ Time Frame: 26 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • currently smoking at least 10 cigarettes per day (confirmed by high exhaled carbon-monoxide (CO))
  • 18 years or older
  • interested in quitting within the next 30 days
  • one or more pre-defined medical illnesses (including cardiovascular disease, other vascular disease, chronic pulmonary disease, cancer, hypertension, diabetes, hyperlipidemia, and recurrent pulmonary infections)

Exclusion Criteria:

  • contraindications to pharmacotherapy (including unstable angina, myocardial infarction within 2 months, severe arrhythmia, seizure disorder, serious mental illness requiring antipsychotic medications)
  • current use of other tobacco products (smokeless tobacco, cigars, pipes, etc.), bupropion, clonidine, nortriptyline, or nicotine replacement medications
  • unable to give consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00770666

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United States, New Jersey
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Rutgers Cancer Institute of New Jersey
Robert Wood Johnson Foundation
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Principal Investigator: Michael B Steinberg, MD, MPH UMDNJ-RWJMS

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Michael Steinberg, MD, MPH, UMDNJ-Robert Wood Johnson Medical School Identifier: NCT00770666    
Other Study ID Numbers: 0220055373
First Posted: October 10, 2008    Key Record Dates
Last Update Posted: October 10, 2008
Last Verified: October 2008
Keywords provided by Rutgers, The State University of New Jersey:
Tobacco dependence treatment
Additional relevant MeSH terms:
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Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors