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Combination Medications vs. Patch Alone for Medically-Ill Smokers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00770666
First Posted: October 10, 2008
Last Update Posted: October 10, 2008
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.
Collaborators:
Rutgers Cancer Institute of New Jersey
Robert Wood Johnson Foundation
Information provided by:
Rutgers, The State University of New Jersey
  Purpose
Randomized clinical trial to evaluate a flexibly-dosed-3-medication combination for up to 6 months in smokers with medical illness

Condition Intervention Phase
Smoking Cessation Drug: Nicotine patch, nicotine inhaler, bupropion Drug: Nicotine patch Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

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

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

Enrollment: 127
Study Start Date: September 2005
Study Completion Date: January 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00770666


Locations
United States, New Jersey
Umdnj-Rwjms
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
Investigators
Principal Investigator: Michael B Steinberg, MD, MPH UMDNJ-RWJMS
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Steinberg, MD, MPH, UMDNJ-Robert Wood Johnson Medical School
ClinicalTrials.gov Identifier: NCT00770666     History of Changes
Other Study ID Numbers: 0220055373
First Submitted: October 9, 2008
First Posted: October 10, 2008
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:
Nicotine
Bupropion
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


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